Trial Outcomes & Findings for Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH) (NCT NCT02265952)
NCT ID: NCT02265952
Last Updated: 2019-12-09
Results Overview
Percent change was reported for low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Baseline (Week 0) up to Week 4
Results posted on
2019-12-09
Participant Flow
The study was conducted at five sites in United States, Canada, and the Netherlands between 04 Feb 2015 and 23 Jul 2018. A total of 12 participants were screened in the study. Out of 12 participants, 9 participants received the study treatment.
This study consisted of 2 screening periods: 1st for main study and 2nd for open label extension (OLE) period. Participants on stable background medical lipid-modifying therapy for at least 4 weeks prior to screening, or who didn't undergo lipid apheresis within 4 weeks prior to screening visit, were directly entered into a 2-week screening period.
Participant milestones
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
REGN1500 300 mg SC/20 mg/kg IV
Participants received REGN1500 SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 \[Day 1499\]) after the last dose of study drug in the OLE treatment period.
|
|---|---|---|
|
Main Study Period
STARTED
|
9
|
0
|
|
Main Study Period
COMPLETED
|
9
|
0
|
|
Main Study Period
NOT COMPLETED
|
0
|
0
|
|
Open Label Extension (OLE) Period
STARTED
|
0
|
8
|
|
Open Label Extension (OLE) Period
COMPLETED
|
0
|
0
|
|
Open Label Extension (OLE) Period
NOT COMPLETED
|
0
|
8
|
Reasons for withdrawal
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
REGN1500 300 mg SC/20 mg/kg IV
Participants received REGN1500 SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 \[Day 1499\]) after the last dose of study drug in the OLE treatment period.
|
|---|---|---|
|
Open Label Extension (OLE) Period
Physician Decision
|
0
|
7
|
|
Open Label Extension (OLE) Period
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Baseline characteristics by cohort
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 9.06 • n=5 Participants
|
|
Age, Customized
< 45 years
|
7 Participants
n=5 Participants
|
|
Age, Customized
≥ 45 to < 65 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 to < 75 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
< 75 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity
Not Reported
|
0 Participants
n=5 Participants
|
|
Race
White
|
7 Participants
n=5 Participants
|
|
Race
Black or African American
|
0 Participants
n=5 Participants
|
|
Race
Asian
|
0 Participants
n=5 Participants
|
|
Race
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race
Other
|
0 Participants
n=5 Participants
|
|
Race
Not Reported
|
2 Participants
n=5 Participants
|
|
Baseline Low-Density Lipoprotein Cholesterol (LDL-C)
|
376.0 Milligram per Deciliter (mg/dL)
STANDARD_DEVIATION 240.85 • n=5 Participants
|
|
Baseline High-Density Lipoprotein Cholesterol (HDL-C)
|
38.8 mg/dL
STANDARD_DEVIATION 14.24 • n=5 Participants
|
|
Baseline Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)
|
392.1 mg/dL
STANDARD_DEVIATION 246.41 • n=5 Participants
|
|
Baseline Apolipoprotein B (Apo B)
|
226.1 mg/dL
STANDARD_DEVIATION 131.70 • n=5 Participants
|
|
Baseline Apolipoprotein CIII (Apo CIII)
|
7.976 mg/dL
STANDARD_DEVIATION 3.3747 • n=5 Participants
|
|
Baseline Triglyceride (TG)
|
80.0 mg/dL
STANDARD_DEVIATION 41.20 • n=5 Participants
|
|
Baseline Lipoprotein(a) (Lp[a])
|
154.9 mg/dL
STANDARD_DEVIATION 109.25 • n=5 Participants
|
|
Baseline Total Cholesterol (Total -C)
|
430.9 mg/dL
STANDARD_DEVIATION 235.60 • n=5 Participants
|
|
Baseline Apolipoprotein A-1 (Apo A-1)
|
110.4 mg/dL
STANDARD_DEVIATION 23.74 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) up to Week 4Percent change was reported for low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period
|
-49.17 Percent Change
Standard Deviation 23.136 • Interval 23.136 to
|
SECONDARY outcome
Timeframe: Baseline (Week 0) up to Week 4Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period
|
-157.34 mg/dL
Standard Deviation 89.590 • Interval 89.59 to
|
SECONDARY outcome
Timeframe: Week 2 to Week 4Absolute change in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period
|
-63.63 Milligram per Deciliter (mg/dL)
Standard Deviation 50.970 • Interval 50.97 to
|
SECONDARY outcome
Timeframe: Week 2 to Week 4Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period
|
-30.05 Percent Change
Standard Deviation 18.503 • Interval 18.503 to
|
SECONDARY outcome
Timeframe: Baseline (Week 0) up to Week 26Population: "n" = Number of participants who were evaluable for this endpoint at a given time point.
Absolute change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 26 (n= 6)
|
-23.98 mg/dL
Standard Deviation 152.794
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Day 4 (n= 9)
|
-39.60 mg/dL
Standard Deviation 41.677
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 1 (n= 9)
|
-67.59 mg/dL
Standard Deviation 46.041
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 2 (n= 9)
|
-93.71 mg/dL
Standard Deviation 86.504
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 3 (n= 9)
|
-129.97 mg/dL
Standard Deviation 90.533
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 4 (n= 9)
|
-157.34 mg/dL
Standard Deviation 89.590
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 5 (n= 8)
|
-179.18 mg/dL
Standard Deviation 101.260
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 6 (n= 9)
|
-183.41 mg/dL
Standard Deviation 111.313
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 8 (n= 9)
|
-176.72 mg/dL
Standard Deviation 118.441
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 10 (n= 9)
|
-151.19 mg/dL
Standard Deviation 78.164
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 12 (n= 9)
|
-109.40 mg/dL
Standard Deviation 74.108
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 13 (n= 2)
|
-170.15 mg/dL
Standard Deviation 105.288
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 14 (n= 9)
|
-104.16 mg/dL
Standard Deviation 78.954
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 15 (n= 2)
|
-186.15 mg/dL
Standard Deviation 119.147
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 16 (n= 9)
|
-97.29 mg/dL
Standard Deviation 179.016
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 17 (n= 2)
|
-174.20 mg/dL
Standard Deviation 103.803
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 18 (n= 7)
|
-62.11 mg/dL
Standard Deviation 167.004
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 20 (n= 2)
|
-155.25 mg/dL
Standard Deviation 79.832
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 22 (n= 7)
|
-41.37 mg/dL
Standard Deviation 169.432
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 23 (n= 2)
|
-155.85 mg/dL
Standard Deviation 78.984
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Change at Week 25 (n= 2)
|
-87.90 mg/dL
Standard Deviation 23.900
|
SECONDARY outcome
Timeframe: Baseline (Week 0) up to Week 26Population: "n" = Number of participants who were evaluable for this endpoint at a given time point.
Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 5 (n= 8)
|
-46.88 Percent Change
Standard Deviation 14.507
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Day 4 (n= 9)
|
-12.76 Percent Change
Standard Deviation 11.086
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 1 (n= 9)
|
-24.00 Percent Change
Standard Deviation 21.078
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 2 (n= 9)
|
-30.13 Percent Change
Standard Deviation 24.402
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 3 (n= 9)
|
-41.38 Percent Change
Standard Deviation 24.986
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 4 (n= 9)
|
-49.17 Percent Change
Standard Deviation 23.136
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 6 (n= 9)
|
-52.13 Percent Change
Standard Deviation 14.768
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 8 (n= 9)
|
-51.59 Percent Change
Standard Deviation 17.910
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 10 (n= 9)
|
-45.61 Percent Change
Standard Deviation 13.839
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 12 (n= 9)
|
-36.54 Percent Change
Standard Deviation 19.281
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 13 (n= 2)
|
-39.84 Percent Change
Standard Deviation 10.753
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 14 (n= 9)
|
-33.02 Percent Change
Standard Deviation 18.538
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 15 (n= 2)
|
-43.38 Percent Change
Standard Deviation 12.814
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 16 (n= 9)
|
-24.98 Percent Change
Standard Deviation 25.441
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 17 (n= 2)
|
-40.99 Percent Change
Standard Deviation 9.950
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 18 (n= 7)
|
-13.72 Percent Change
Standard Deviation 28.424
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 20 (n= 2)
|
-37.17 Percent Change
Standard Deviation 5.503
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 22 (n= 7)
|
-9.50 Percent Change
Standard Deviation 38.456
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 23 (n= 2)
|
-37.37 Percent Change
Standard Deviation 5.217
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 25 (n= 2)
|
-22.12 Percent Change
Standard Deviation 2.537
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change at Week 26 (n= 6)
|
-10.27 Percent Change
Standard Deviation 25.806
|
SECONDARY outcome
Timeframe: Baseline (Week 26) up to Week 214Population: "n" = Number of participants who were evaluable for this endpoint at a given time point.
Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) up to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=8 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 44 (n= 8)
|
-140.36 mg/dL
Standard Deviation 109.275
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 40 (n= 6)
|
-127.13 mg/dL
Standard Deviation 122.808
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 41 (n= 6)
|
-163.28 mg/dL
Standard Deviation 137.365
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 42 (n= 6)
|
-142.65 mg/dL
Standard Deviation 126.647
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 46 (n= 8)
|
-123.25 mg/dL
Standard Deviation 112.503
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 50 (n= 8)
|
-106.61 mg/dL
Standard Deviation 99.458
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 54 (n= 8)
|
-13.38 mg/dL
Standard Deviation 177.649
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 58 (n= 6)
|
-48.27 mg/dL
Standard Deviation 93.443
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 70 (n= 4)
|
-117.93 mg/dL
Standard Deviation 145.917
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 82 (n= 4)
|
-63.88 mg/dL
Standard Deviation 64.738
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 94 (n= 1)
|
-369.90 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 106 (n= 1)
|
-290.00 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at ET (n= 8)
|
-9.78 mg/dL
Standard Deviation 64.930
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at EOS (n= 3)
|
95.63 mg/dL
Standard Deviation 147.100
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 26 (n= 8)
|
261.34 mg/dL
Standard Deviation 178.792
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 27 (n= 8)
|
-58.73 mg/dL
Standard Deviation 56.992
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 28 (n= 8)
|
-88.16 mg/dL
Standard Deviation 83.196
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 29 (n= 8)
|
-116.20 mg/dL
Standard Deviation 102.219
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 30 (n= 7)
|
-87.80 mg/dL
Standard Deviation 108.905
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 31 (n= 8)
|
-144.99 mg/dL
Standard Deviation 130.764
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 32 (n= 8)
|
-159.16 mg/dL
Standard Deviation 128.072
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 34 (n= 8)
|
-128.38 mg/dL
Standard Deviation 108.331
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 36 (n= 8)
|
-105.94 mg/dL
Standard Deviation 89.990
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 38 (n= 8)
|
-79.98 mg/dL
Standard Deviation 97.851
|
|
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Change at Week 39 (n= 6)
|
-138.28 mg/dL
Standard Deviation 123.133
|
SECONDARY outcome
Timeframe: Baseline (Week 26) up to Week 214Population: "n" = Number of participants who were evaluable for this endpoint at a given time point.
Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) to week 214 in the OLE period. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=8 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Baseline (n= 8)
|
261.34 Percent Change
Standard Deviation 178.792
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 27 (n= 8)
|
-22.49 Percent Change
Standard Deviation 16.520
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 28 (n= 8)
|
-36.74 Percent Change
Standard Deviation 20.931
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 29 (n= 8)
|
-44.35 Percent Change
Standard Deviation 20.817
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 30 (n= 7)
|
-37.37 Percent Change
Standard Deviation 31.297
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 31 (n= 8)
|
-50.74 Percent Change
Standard Deviation 20.147
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 32 (n= 8)
|
-60.03 Percent Change
Standard Deviation 18.502
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 34 (n= 8)
|
-53.03 Percent Change
Standard Deviation 22.130
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 36 (n= 8)
|
-47.90 Percent Change
Standard Deviation 21.623
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 38 (n= 8)
|
-37.05 Percent Change
Standard Deviation 25.341
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 39 (n= 6)
|
-59.83 Percent Change
Standard Deviation 22.220
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 40 (n= 6)
|
-53.90 Percent Change
Standard Deviation 20.970
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 41 (n= 6)
|
-66.28 Percent Change
Standard Deviation 18.555
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 42 (n= 6)
|
-59.59 Percent Change
Standard Deviation 18.950
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 44 (n= 8)
|
-57.64 Percent Change
Standard Deviation 18.599
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 46 (n= 8)
|
-48.74 Percent Change
Standard Deviation 19.717
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 50 (n= 8)
|
-42.31 Percent Change
Standard Deviation 23.194
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 54 (n= 8)
|
-13.60 Percent Change
Standard Deviation 44.339
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 58 (n= 6)
|
-12.86 Percent Change
Standard Deviation 27.645
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 70 (n= 4)
|
-38.61 Percent Change
Standard Deviation 36.151
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 82 (n= 4)
|
-24.68 Percent Change
Standard Deviation 30.789
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 94 (n= 1)
|
-81.67 Percent Change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at Week 106 (n= 1)
|
-64.03 Percent Change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at ET (n= 8)
|
-17.65 Percent Change
Standard Deviation 28.813
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change at EOS (n= 3)
|
19.59 Percent Change
Standard Deviation 40.976
|
SECONDARY outcome
Timeframe: Baseline (Week 0) up to Week 26Population: "n" = Number of participants who were evaluable for this endpoint at a given time point.
Absolute change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to Week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 26 (n = 6)
|
-25.47 mg/dL
Standard Deviation 156.948
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Change at Week 12 (n = 9)
|
-20.9 mg/dL
Standard Deviation 16.30
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Change at Week 2 (n = 9)
|
-53.0 mg/dL
Standard Deviation 56.29
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Change at Week 3 (n = 9)
|
-81.0 mg/dL
Standard Deviation 54.97
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Change at Week 4 (n = 9)
|
-96.3 mg/dL
Standard Deviation 56.01
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Change at Week 5 (n = 8)
|
-104.6 mg/dL
Standard Deviation 61.43
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Change at Week 6 (n = 9)
|
-100.7 mg/dL
Standard Deviation 71.12
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Change at Week 8 (n = 9)
|
-96.8 mg/dL
Standard Deviation 67.36
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Change at Week 12 (n = 9)
|
-60.0 mg/dL
Standard Deviation 63.61
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Change at Week 14 (n = 9)
|
-61.7 mg/dL
Standard Deviation 64.18
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Change at Week 16 (n = 9)
|
-62.6 mg/dL
Standard Deviation 98.77
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Change at Week 18 (n = 7)
|
-28.6 mg/dL
Standard Deviation 80.58
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Change at Week 20 (n = 2)
|
-114.0 mg/dL
Standard Deviation 67.88
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Change at Week 22 (n = 7)
|
-22.7 mg/dL
Standard Deviation 77.82
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Change at Week 23 (n = 2)
|
-119.0 mg/dL
Standard Deviation 79.20
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Change at Week 26 (n = 6)
|
-4.7 mg/dL
Standard Deviation 68.52
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Day 4 (n = 9)
|
-44.61 mg/dL
Standard Deviation 42.322
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 1 (n = 9)
|
-72.16 mg/dL
Standard Deviation 46.480
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 2 (n = 9)
|
-97.12 mg/dL
Standard Deviation 88.026
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 3 (n = 9)
|
-138.09 mg/dL
Standard Deviation 91.574
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 4 (n = 9)
|
-165.64 mg/dL
Standard Deviation 93.130
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 5 (n = 8)
|
-187.46 mg/dL
Standard Deviation 104.826
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 6 (n = 9)
|
-191.20 mg/dL
Standard Deviation 116.337
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 8 (n = 9)
|
-182.98 mg/dL
Standard Deviation 121.701
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 10 (n = 9)
|
-156.98 mg/dL
Standard Deviation 81.636
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 12 (n = 9)
|
-116.20 mg/dL
Standard Deviation 77.582
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 13 (n = 2)
|
-180.25 mg/dL
Standard Deviation 116.178
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 14 (n = 9)
|
-108.58 mg/dL
Standard Deviation 83.773
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 15 (n = 2)
|
-196.85 mg/dL
Standard Deviation 135.270
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 16 (n = 9)
|
-99.58 mg/dL
Standard Deviation 186.796
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 17 (n = 2)
|
-185.40 mg/dL
Standard Deviation 114.834
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 18 (n = 7)
|
-60.41 mg/dL
Standard Deviation 169.805
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 20 (n = 2)
|
-161.90 mg/dL
Standard Deviation 85.843
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 22 (n = 7)
|
-41.16 mg/dL
Standard Deviation 175.121
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 23 (n = 2)
|
-163.25 mg/dL
Standard Deviation 85.065
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Change at Week 25 (n = 2)
|
-92.20 mg/dL
Standard Deviation 29.981
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Day 4 (n = 9)
|
-50.36 mg/dL
Standard Deviation 41.860
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 1 (n = 9)
|
-81.99 mg/dL
Standard Deviation 46.513
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 2 (n = 9)
|
-109.03 mg/dL
Standard Deviation 86.365
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 3 (n = 9)
|
-154.10 mg/dL
Standard Deviation 86.927
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 4 (n = 9)
|
-180.79 mg/dL
Standard Deviation 87.304
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 5 (n = 8)
|
-199.11 mg/dL
Standard Deviation 98.202
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 6 (n = 9)
|
-207.63 mg/dL
Standard Deviation 107.187
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 8 (n = 9)
|
-195.18 mg/dL
Standard Deviation 113.993
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 10 (n = 9)
|
-167.87 mg/dL
Standard Deviation 76.914
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 12 (n = 9)
|
-122.94 mg/dL
Standard Deviation 76.104
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 13 (n = 2)
|
-188.45 mg/dL
Standard Deviation 113.349
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 14 (n = 9)
|
-114.68 mg/dL
Standard Deviation 84.082
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 15 (n = 2)
|
-205.60 mg/dL
Standard Deviation 136.047
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 16 (n = 9)
|
-105.24 mg/dL
Standard Deviation 186.103
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 17 (n = 2)
|
-195.00 mg/dL
Standard Deviation 111.157
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 18 (n = 7)
|
-63.27 mg/dL
Standard Deviation 166.911
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 20 (n = 2)
|
-170.45 mg/dL
Standard Deviation 78.135
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 22 (n = 7)
|
-41.30 mg/dL
Standard Deviation 174.597
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 23 (n = 2)
|
-167.55 mg/dL
Standard Deviation 80.539
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 25 (n = 2)
|
-90.15 mg/dL
Standard Deviation 26.234
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Change at Week 26 (n = 6)
|
-30.77 mg/dL
Standard Deviation 156.736
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Change at Week 2 (n = 9)
|
-22.4 mg/dL
Standard Deviation 30.18
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Change at Week 3 (n = 9)
|
-20.8 mg/dL
Standard Deviation 30.11
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Change at Week 4 (n = 9)
|
-21.1 mg/dL
Standard Deviation 28.29
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Change at Week 5 (n = 8)
|
-30.1 mg/dL
Standard Deviation 24.91
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Change at Week 6 (n = 9)
|
-25.0 mg/dL
Standard Deviation 31.40
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Change at Week 8 (n = 9)
|
-28.9 mg/dL
Standard Deviation 23.81
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Change at Week 14 (n = 9)
|
-22.3 mg/dL
Standard Deviation 21.01
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Change at Week 16 (n = 9)
|
-26.9 mg/dL
Standard Deviation 38.97
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Change at Week 18 (n = 7)
|
-29.9 mg/dL
Standard Deviation 29.27
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Change at Week 20 (n = 2)
|
-19.0 mg/dL
Standard Deviation 46.67
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Change at Week 22 (n = 7)
|
-24.3 mg/dL
Standard Deviation 37.53
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Change at Week 23 (n = 2)
|
-12.5 mg/dL
Standard Deviation 19.09
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Change at Week 26 (n = 6)
|
-16.3 mg/dL
Standard Deviation 37.90
|
SECONDARY outcome
Timeframe: Baseline (Week 0) up to Week 26Population: "n" = Number of participants who were evaluable for this endpoint at a given time point.
Percent change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to week 26. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Percent change at Week 2 (n = 9)
|
-24.38 Percent Change
Standard Deviation 20.959
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Percent change at Week 3 (n = 9)
|
-38.63 Percent Change
Standard Deviation 22.114
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Percent change at Week 4 (n = 9)
|
-45.89 Percent Change
Standard Deviation 18.222
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Percent change at Week 5 (n = 8)
|
-42.28 Percent Change
Standard Deviation 13.247
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Percent change at Week 6 (n = 9)
|
-43.12 Percent Change
Standard Deviation 14.716
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Percent change at Week 8 (n = 9)
|
-42.66 Percent Change
Standard Deviation 14.475
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Percent change at Week 12 (n = 9)
|
-29.47 Percent Change
Standard Deviation 21.736
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Percent change at Week 14 (n = 9)
|
-27.42 Percent Change
Standard Deviation 18.418
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Percent change at Week 16 (n = 9)
|
-21.60 Percent Change
Standard Deviation 24.970
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Percent change at Week 18 (n = 7)
|
-7.63 Percent Change
Standard Deviation 24.347
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Percent change at Week 20 (n = 2)
|
-39.32 Percent Change
Standard Deviation 6.481
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Percent change at Week 22 (n = 7)
|
-8.07 Percent Change
Standard Deviation 30.444
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Percent change at Week 23 (n = 2)
|
-40.29 Percent Change
Standard Deviation 10.089
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Apo B: Percent change at Week 26 (n = 6)
|
-2.03 Percent Change
Standard Deviation 25.320
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Day 4 (n = 9)
|
-13.61 Percent Change
Standard Deviation 10.721
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 1 (n = 9)
|
-24.12 Percent Change
Standard Deviation 20.083
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 2 (n = 9)
|
-29.61 Percent Change
Standard Deviation 23.406
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 3 (n = 9)
|
-41.62 Percent Change
Standard Deviation 23.969
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 4 (n = 9)
|
-48.91 Percent Change
Standard Deviation 22.257
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 5 (n = 8)
|
-46.61 Percent Change
Standard Deviation 14.172
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 6 (n = 9)
|
-51.49 Percent Change
Standard Deviation 14.344
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 8 (n = 9)
|
-50.65 Percent Change
Standard Deviation 17.231
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 10 (n = 9)
|
-44.80 Percent Change
Standard Deviation 13.148
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 12 (n = 9)
|
-36.40 Percent Change
Standard Deviation 18.711
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 13 (n = 2)
|
-39.84 Percent Change
Standard Deviation 11.313
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 14 (n = 9)
|
-32.71 Percent Change
Standard Deviation 18.214
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 15 (n = 2)
|
-43.09 Percent Change
Standard Deviation 14.482
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 16 (n = 9)
|
-24.22 Percent Change
Standard Deviation 25.899
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 17 (n = 2)
|
-41.21 Percent Change
Standard Deviation 10.455
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 18 (n = 7)
|
-12.70 Percent Change
Standard Deviation 27.798
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 20 (n = 2)
|
-36.71 Percent Change
Standard Deviation 5.471
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 22 (n = 7)
|
-9.43 Percent Change
Standard Deviation 37.102
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 23 (n = 2)
|
-37.10 Percent Change
Standard Deviation 5.138
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 25 (n = 2)
|
-21.86 Percent Change
Standard Deviation 1.676
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Non-HDL-C: Percent change at Week 26 (n = 6)
|
-9.99 Percent Change
Standard Deviation 25.292
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Day 4 (n = 9)
|
-13.18 Percent Change
Standard Deviation 8.932
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 1 (n = 9)
|
-23.23 Percent Change
Standard Deviation 16.602
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 2 (n = 9)
|
-29.14 Percent Change
Standard Deviation 20.307
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 3 (n = 9)
|
-40.81 Percent Change
Standard Deviation 21.011
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 4 (n = 9)
|
-46.95 Percent Change
Standard Deviation 19.083
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 5 (n = 8)
|
-45.43 Percent Change
Standard Deviation 12.909
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 6 (n = 9)
|
-50.68 Percent Change
Standard Deviation 13.327
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 8 (n = 9)
|
-48.29 Percent Change
Standard Deviation 15.556
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 10 (n = 9)
|
-42.15 Percent Change
Standard Deviation 10.858
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 12 (n = 9)
|
-33.48 Percent Change
Standard Deviation 16.136
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 13 (n = 2)
|
-38.98 Percent Change
Standard Deviation 10.525
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 14 (n = 9)
|
-29.66 Percent Change
Standard Deviation 15.759
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 15 (n = 2)
|
-42.01 Percent Change
Standard Deviation 14.356
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 16 (n = 9)
|
-23.51 Percent Change
Standard Deviation 25.208
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 17 (n = 2)
|
-40.59 Percent Change
Standard Deviation 9.468
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 18 (n = 7)
|
-12.65 Percent Change
Standard Deviation 26.105
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 20 (n = 2)
|
-36.28 Percent Change
Standard Deviation 3.862
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 22 (n = 7)
|
-7.73 Percent Change
Standard Deviation 33.729
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 23 (n = 2)
|
-35.50 Percent Change
Standard Deviation 4.662
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 25 (n = 2)
|
-19.82 Percent Change
Standard Deviation 1.459
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Total-C: Percent change at Week 26 (n = 6)
|
-10.05 Percent Change
Standard Deviation 22.903
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Percent change at Week 2 (n = 9)
|
-11.64 Percent Change
Standard Deviation 20.323
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Percent change at Week 3 (n = 9)
|
-12.25 Percent Change
Standard Deviation 19.350
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Percent change at Week 4 (n = 9)
|
-10.85 Percent Change
Standard Deviation 24.465
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Percent change at Week 5 (n = 8)
|
-23.79 Percent Change
Standard Deviation 17.908
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Percent change at Week 6 (n = 9)
|
-17.12 Percent Change
Standard Deviation 23.680
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Percent change at Week 8 (n = 9)
|
-17.24 Percent Change
Standard Deviation 17.764
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Percent change at Week 12 (n = 9)
|
-13.09 Percent Change
Standard Deviation 12.614
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Percent change at Week 14 (n = 9)
|
-13.54 Percent Change
Standard Deviation 10.151
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Percent change at Week 16 (n = 9)
|
-16.93 Percent Change
Standard Deviation 24.795
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Percent change at Week 18 (n = 7)
|
-19.61 Percent Change
Standard Deviation 21.686
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Percent change at Week 20 (n = 2)
|
-19.72 Percent Change
Standard Deviation 32.894
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Percent change at Week 22 (n = 7)
|
-10.37 Percent Change
Standard Deviation 29.230
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Percent change at Week 23 (n = 2)
|
-10.62 Percent Change
Standard Deviation 15.373
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Lp(a): Percent change at Week 26 (n = 6)
|
3.46 Percent Change
Standard Deviation 39.400
|
SECONDARY outcome
Timeframe: Baseline (Week 26) up to Week 214Population: "n" = Number of participants who were evaluable for this endpoint at a given time point.
Absolute changein Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline to week 214 in open label extension (OLE) period. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET = Early Termination; EOS = End of Study)
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=8 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Change at Week 30 (n= 7)
|
-48.1 mg/dL
Standard Deviation 61.41
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Change at Week 34 (n= 8)
|
-65.9 mg/dL
Standard Deviation 58.96
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Change at Week 38 (n= 8)
|
-40.9 mg/dL
Standard Deviation 56.34
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Change at Week 42 (n= 6)
|
-79.5 mg/dL
Standard Deviation 71.19
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Change at Week 44 (n= 8)
|
-78.6 mg/dL
Standard Deviation 58.93
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Change at Week 50 (n= 8)
|
-57.8 mg/dL
Standard Deviation 50.82
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Change at Week 70 (n= 4)
|
-60.3 mg/dL
Standard Deviation 78.24
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Change at Week 82 (n= 4)
|
-38.0 mg/dL
Standard Deviation 35.66
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Change at Week 94 (n= 1)
|
-212.0 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Change at Week 106 (n= 1)
|
-173.0 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Change at ET (n= 8)
|
-3.5 mg/dL
Standard Deviation 42.88
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Change at EOS (n= 3)
|
65.0 mg/dL
Standard Deviation 100.53
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 27 (n= 8)
|
-65.06 mg/dL
Standard Deviation 61.756
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 28 (n= 8)
|
-95.65 mg/dL
Standard Deviation 87.499
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 29 (n= 8)
|
-122.94 mg/dL
Standard Deviation 106.296
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 30 (n= 7)
|
-94.33 mg/dL
Standard Deviation 113.286
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 31 (n= 8)
|
-152.98 mg/dL
Standard Deviation 135.977
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 32 (n= 8)
|
-166.94 mg/dL
Standard Deviation 133.990
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 34 (n= 8)
|
-133.69 mg/dL
Standard Deviation 112.247
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 36 (n= 8)
|
-111.06 mg/dL
Standard Deviation 93.635
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 38 (n= 8)
|
-84.16 mg/dL
Standard Deviation 101.210
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 39 (n= 6)
|
-146.35 mg/dL
Standard Deviation 128.368
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 40 (n= 6)
|
-134.50 mg/dL
Standard Deviation 128.198
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 41 (n= 6)
|
-171.25 mg/dL
Standard Deviation 143.692
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C:Change at Week 42 (n= 6)
|
-150.28 mg/dL
Standard Deviation 132.214
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 44 (n= 8)
|
-149.00 mg/dL
Standard Deviation 114.152
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 46 (n= 8)
|
-129.99 mg/dL
Standard Deviation 116.770
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 50 (n= 8)
|
-110.83 mg/dL
Standard Deviation 104.353
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 54 (n= 8)
|
-14.79 mg/dL
Standard Deviation 178.797
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 58 (n= 6)
|
-49.13 mg/dL
Standard Deviation 97.212
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 70 (n= 4)
|
-121.83 mg/dL
Standard Deviation 152.887
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 82 (n= 4)
|
-69.00 mg/dL
Standard Deviation 66.715
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 94 (n= 1)
|
-388.10 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at Week 106 (n= 1)
|
-303.10 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at ET (n= 8)
|
-12.45 mg/dL
Standard Deviation 64.513
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Change at EOS (n= 3)
|
102.07 mg/dL
Standard Deviation 153.301
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 27 (n= 8)
|
-73.80 mg/dL
Standard Deviation 60.737
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 28 (n= 8)
|
-107.78 mg/dL
Standard Deviation 83.051
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 29 (n= 8)
|
-134.33 mg/dL
Standard Deviation 102.667
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 30 (n= 7)
|
-107.61 mg/dL
Standard Deviation 109.689
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 31 (n= 8)
|
-166.85 mg/dL
Standard Deviation 130.925
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 32 (n= 8)
|
-181.09 mg/dL
Standard Deviation 130.048
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 34 (n= 8)
|
-148.90 mg/dL
Standard Deviation 106.534
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 36 (n= 8)
|
-125.14 mg/dL
Standard Deviation 89.065
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 38 (n= 8)
|
-93.00 mg/dL
Standard Deviation 99.558
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 39 (n= 6)
|
-160.38 mg/dL
Standard Deviation 125.452
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 40 (n= 6)
|
-150.42 mg/dL
Standard Deviation 124.695
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 41 (n= 6)
|
-188.42 mg/dL
Standard Deviation 141.249
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 42 (n= 6)
|
-166.80 mg/dL
Standard Deviation 128.247
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 44 (n= 8)
|
-164.68 mg/dL
Standard Deviation 110.222
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 46 (n= 8)
|
-144.69 mg/dL
Standard Deviation 110.682
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 50 (n= 8)
|
-123.04 mg/dL
Standard Deviation 99.299
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 54 (n= 8)
|
-23.80 mg/dL
Standard Deviation 180.982
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 58 (n= 6)
|
-54.45 mg/dL
Standard Deviation 97.160
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 70 (n= 4)
|
-132.55 mg/dL
Standard Deviation 152.664
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 82 (n= 4)
|
-75.43 mg/dL
Standard Deviation 67.802
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 94 (n= 1)
|
-392.30 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at Week 106 (n= 1)
|
-303.10 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at ET (n= 8)
|
-20.38 mg/dL
Standard Deviation 68.809
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Change at EOS (n= 3)
|
100.40 mg/dL
Standard Deviation 144.828
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Change at Week 30 (n= 7)
|
-9.0 mg/dL
Standard Deviation 27.59
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Change at Week 34 (n= 8)
|
-10.8 mg/dL
Standard Deviation 24.00
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Change at Week 38 (n= 8)
|
-16.0 mg/dL
Standard Deviation 19.70
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Change at Week 42 (n= 6)
|
-0.8 mg/dL
Standard Deviation 41.36
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Change at Week 44 (n= 8)
|
1.5 mg/dL
Standard Deviation 37.73
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Change at Week 50 (n= 8)
|
11.6 mg/dL
Standard Deviation 48.23
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Change at Week 70 (n= 4)
|
36.8 mg/dL
Standard Deviation 77.92
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Change at Week 82 (n= 4)
|
-5.3 mg/dL
Standard Deviation 27.04
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Change at Week 94 (n= 1)
|
-18.0 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Change at Week 106 (n= 1)
|
39.0 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Change at Week ET (n= 8)
|
11.6 mg/dL
Standard Deviation 26.72
|
|
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Change at EOS (n= 3)
|
18.3 mg/dL
Standard Deviation 18.01
|
SECONDARY outcome
Timeframe: Baseline (Week 26) up to Week 214Population: "n" = Number of participants who were evaluable for this endpoint at a given time point.
Percent change was reported in Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 26) up to week 214 in OLE Period. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=8 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Percent change at Week 30 (n= 7)
|
-30.59 Percent change
Standard Deviation 25.991
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Percent change at Week 34 (n= 8)
|
-41.27 Percent change
Standard Deviation 19.573
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Percent change at Week 38 (n= 8)
|
-29.02 Percent change
Standard Deviation 25.029
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Percent change at Week 42 (n= 6)
|
-50.90 Percent change
Standard Deviation 17.497
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Percent change at Week 44 (n= 8)
|
-48.59 Percent change
Standard Deviation 16.201
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Percent change at Week 50 (n= 8)
|
-36.68 Percent change
Standard Deviation 19.620
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Percent change at Week 70 (n= 4)
|
-33.44 Percent change
Standard Deviation 26.773
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Percent change at Week 82 (n= 4)
|
-24.87 Percent change
Standard Deviation 17.148
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Percent change at Week 94 (n= 1)
|
-77.09 Percent change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Percent change at Week 106 (n= 1)
|
-62.91 Percent change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Percent change at ET (n= 8)
|
-11.94 Percent change
Standard Deviation 25.708
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo B: Percent change at EOS (n= 3)
|
22.60 Percent change
Standard Deviation 38.988
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 27 (n= 8)
|
-23.62 Percent change
Standard Deviation 15.342
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 28 (n= 8)
|
-37.22 Percent change
Standard Deviation 19.207
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 29 (n= 8)
|
-44.30 Percent change
Standard Deviation 19.766
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 30 (n= 7)
|
-37.90 Percent change
Standard Deviation 29.133
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 31 (n= 8)
|
-50.59 Percent change
Standard Deviation 19.285
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 32 (n= 8)
|
-59.09 Percent change
Standard Deviation 18.200
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 34 (n= 8)
|
-51.55 Percent change
Standard Deviation 21.112
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 36 (n= 8)
|
-46.62 Percent change
Standard Deviation 20.797
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 38 (n= 8)
|
-36.10 Percent change
Standard Deviation 24.473
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 39 (n= 6)
|
-59.25 Percent change
Standard Deviation 21.381
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 40 (n= 6)
|
-53.24 Percent change
Standard Deviation 20.135
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 41 (n= 6)
|
-65.07 Percent change
Standard Deviation 18.375
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 42 (n= 6)
|
-58.92 Percent change
Standard Deviation 18.287
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 44 (n= 8)
|
-57.03 Percent change
Standard Deviation 17.675
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 46 (n= 8)
|
-48.27 Percent change
Standard Deviation 18.674
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 50 (n= 8)
|
-41.16 Percent change
Standard Deviation 22.284
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 54 (n= 8)
|
-12.93 Percent change
Standard Deviation 42.412
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 58 (n= 6)
|
-12.28 Percent change
Standard Deviation 26.060
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 70 (n= 4)
|
-37.68 Percent change
Standard Deviation 35.771
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 82 (n= 4)
|
-26.16 Percent change
Standard Deviation 27.153
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 94 (n= 1)
|
-81.52 Percent change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at Week 106 (n= 1)
|
-63.66 Percent change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at ET (n= 8)
|
-17.65 Percent change
Standard Deviation 27.339
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Non- HDL-C: Percent change at EOS (n= 3)
|
19.98 Percent change
Standard Deviation 40.313
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 27 (n= 8)
|
-22.24 Percent change
Standard Deviation 11.566
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 28 (n= 8)
|
-34.78 Percent change
Standard Deviation 14.984
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 29 (n= 8)
|
-40.57 Percent change
Standard Deviation 14.335
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 30 (n= 7)
|
-36.37 Percent change
Standard Deviation 23.550
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 31 (n= 8)
|
-48.83 Percent change
Standard Deviation 16.944
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 32 (n= 8)
|
-55.05 Percent change
Standard Deviation 16.624
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 34 (n= 8)
|
-48.67 Percent change
Standard Deviation 18.123
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 36 (n= 8)
|
-44.16 Percent change
Standard Deviation 19.175
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 38 (n= 8)
|
-33.29 Percent change
Standard Deviation 22.145
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 39 (n= 6)
|
-54.40 Percent change
Standard Deviation 19.803
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 40 (n= 6)
|
-50.13 Percent change
Standard Deviation 18.316
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 41 (n= 6)
|
-60.87 Percent change
Standard Deviation 17.966
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 42 (n= 6)
|
-54.88 Percent change
Standard Deviation 15.886
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 44 (n= 8)
|
-53.41 Percent change
Standard Deviation 16.231
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 46 (n= 8)
|
-46.06 Percent change
Standard Deviation 16.855
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 50 (n= 8)
|
-39.04 Percent change
Standard Deviation 19.318
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 54 (n= 8)
|
-12.82 Percent change
Standard Deviation 38.323
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 58 (n= 6)
|
-13.78 Percent change
Standard Deviation 21.976
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 70 (n= 4)
|
-36.63 Percent change
Standard Deviation 32.371
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 82 (n= 4)
|
-23.09 Percent change
Standard Deviation 19.171
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 94 (n= 1)
|
-77.50 Percent change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at Week 106 (n= 1)
|
-59.88 Percent change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at ET (n= 8)
|
-16.76 Percent change
Standard Deviation 25.085
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Total-C: Percent change at EOS (n= 3)
|
18.20 Percent change
Standard Deviation 33.900
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Percent change at Week 30 (n= 7)
|
-3.57 Percent change
Standard Deviation 24.610
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Percent change at Week 34 (n= 8)
|
-6.43 Percent change
Standard Deviation 21.281
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Percent change at Week 38 (n= 8)
|
-9.50 Percent change
Standard Deviation 14.429
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Percent change at Week 42 (n= 6)
|
-4.76 Percent change
Standard Deviation 24.227
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Percent change at Week 44 (n= 8)
|
-5.13 Percent change
Standard Deviation 25.377
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Percent change at Week 50 (n= 8)
|
1.02 Percent change
Standard Deviation 29.756
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Percent change at Week 70 (n= 4)
|
15.80 Percent change
Standard Deviation 36.280
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Percent change at Week 82 (n= 4)
|
-3.77 Percent change
Standard Deviation 16.168
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Percent change at Week 94 (n= 1)
|
-11.92 Percent change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Percent change at Week 106 (n= 1)
|
25.83 Percent change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Percent change at ET (n= 8)
|
9.96 Percent change
Standard Deviation 21.597
|
|
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Lp(a): Percent change at EOS (n= 3)
|
40.51 Percent change
Standard Deviation 39.616
|
SECONDARY outcome
Timeframe: Baseline (Week 0) up to Week 26Percentage of participants who achieved reduction in low-density lipoprotein cholesterol (LDL-C) of greater than or equal to (≥) 25 percent (%) from baseline in the main study period was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 0) in the Main Study Period
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 26) to Week 214Percentage of participants who achieved a reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 25% from baseline (week 26) to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=8 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 26) in the Open Label Extension (OLE) Period
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 26Percentage of participants who achieved a reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 50% from baseline (week 0) to week 26 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 0) in the Main Study Period
|
77.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 26) up to Week 214Percentage of participants who achieved reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 50% from baseline (week 26) in the OLE period was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=8 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 26) in the Open Label Extension (OLE) Period
|
87.5 Percentage
|
SECONDARY outcome
Timeframe: Baseline (Week 0) up to Week 26Population: "n" = Number of participants who were evaluable for this endpoint at a given time point.
Absolute change was reported in HDL-C, TG, and Apo A-1 from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period.
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Day 4 (n = 9)
|
-5.81 mg/dL
Standard Deviation 4.789
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 1 (n = 9)
|
-9.92 mg/dL
Standard Deviation 6.578
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 2 (n = 9)
|
-11.99 mg/dL
Standard Deviation 7.351
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 3 (n = 9)
|
-16.02 mg/dL
Standard Deviation 10.737
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 4 (n = 9)
|
-15.07 mg/dL
Standard Deviation 10.792
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 5 (n = 8)
|
-11.66 mg/dL
Standard Deviation 8.442
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 6 (n = 9)
|
-16.46 mg/dL
Standard Deviation 11.868
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 8 (n = 9)
|
-12.06 mg/dL
Standard Deviation 11.334
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 10 (n = 9)
|
-10.94 mg/dL
Standard Deviation 8.215
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 12 (n = 9)
|
-6.82 mg/dL
Standard Deviation 6.811
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 13 (n = 2)
|
-8.10 mg/dL
Standard Deviation 2.970
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 14 (n = 9)
|
-6.18 mg/dL
Standard Deviation 4.205
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 15 (n = 2)
|
-8.70 mg/dL
Standard Deviation 0.566
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 16 (n = 9)
|
-5.54 mg/dL
Standard Deviation 5.785
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 17 (n = 2)
|
-9.40 mg/dL
Standard Deviation 3.818
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 18 (n = 7)
|
-2.93 mg/dL
Standard Deviation 7.435
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 20 (n = 2)
|
-8.70 mg/dL
Standard Deviation 8.202
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 22 (n = 7)
|
-0.30 mg/dL
Standard Deviation 6.943
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 23 (n = 2)
|
-4.00 mg/dL
Standard Deviation 4.384
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 25 (n = 2)
|
2.50 mg/dL
Standard Deviation 3.818
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Change at Week 26 (n = 6)
|
-5.30 mg/dL
Standard Deviation 5.266
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Day 4 (n = 9)
|
-25.17 mg/dL
Standard Deviation 18.545
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 1 (n = 9)
|
-21.41 mg/dL
Standard Deviation 17.603
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 2 (n = 9)
|
-15.83 mg/dL
Standard Deviation 15.908
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 3 (n = 9)
|
-39.73 mg/dL
Standard Deviation 31.977
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 4 (n = 9)
|
-40.81 mg/dL
Standard Deviation 30.277
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 5 (n = 8)
|
-42.04 mg/dL
Standard Deviation 28.887
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 6 (n = 9)
|
-38.73 mg/dL
Standard Deviation 35.120
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 8 (n = 9)
|
-30.37 mg/dL
Standard Deviation 26.383
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 10 (n = 9)
|
-28.79 mg/dL
Standard Deviation 21.095
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 12 (n = 9)
|
-33.23 mg/dL
Standard Deviation 32.901
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 13 (n = 2)
|
-49.15 mg/dL
Standard Deviation 56.922
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 14 (n = 9)
|
-22.11 mg/dL
Standard Deviation 35.348
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 15 (n = 2)
|
-52.20 mg/dL
Standard Deviation 82.590
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 16 (n = 9)
|
-11.20 mg/dL
Standard Deviation 48.136
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 17 (n = 2)
|
-55.35 mg/dL
Standard Deviation 58.195
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 18 (n = 7)
|
9.77 mg/dL
Standard Deviation 24.537
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 20 (n = 2)
|
-33.65 mg/dL
Standard Deviation 33.729
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 22 (n = 7)
|
1.90 mg/dL
Standard Deviation 33.916
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 23 (n = 2)
|
-36.30 mg/dL
Standard Deviation 31.254
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 25 (n = 2)
|
-23.45 mg/dL
Standard Deviation 34.436
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Change at Week 26 (n = 6)
|
-5.87 mg/dL
Standard Deviation 28.748
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Change at Week 2 (n = 9)
|
-28.6 mg/dL
Standard Deviation 18.64
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Change at Week 3 (n = 9)
|
-43.3 mg/dL
Standard Deviation 22.54
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Change at Week 4 (n = 9)
|
-43.4 mg/dL
Standard Deviation 16.88
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Change at Week 5 (n = 8)
|
-35.8 mg/dL
Standard Deviation 17.53
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Change at Week 6 (n = 9)
|
-40.7 mg/dL
Standard Deviation 19.86
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Change at Week 8 (n = 9)
|
-33.6 mg/dL
Standard Deviation 20.64
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Change at Week 12 (n = 9)
|
-17.2 mg/dL
Standard Deviation 20.04
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Change at Week 14 (n = 9)
|
-17.7 mg/dL
Standard Deviation 11.97
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Change at Week 16 (n = 9)
|
-11.3 mg/dL
Standard Deviation 16.50
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Change at Week 18 (n = 7)
|
-4.9 mg/dL
Standard Deviation 17.72
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Change at Week 20 (n = 2)
|
-24.0 mg/dL
Standard Deviation 8.49
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Change at Week 22 (n = 7)
|
1.9 mg/dL
Standard Deviation 15.42
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Change at Week 23 (n = 2)
|
-23.0 mg/dL
Standard Deviation 8.49
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Change at Week 26 (n = 6)
|
-10.8 mg/dL
Standard Deviation 13.83
|
SECONDARY outcome
Timeframe: Baseline (Week 0) up to Week 26Population: "n" = Number of participants who were evaluable for this endpoint at a given time point.
Percent change was reported in HDL-C, TG, and Apo A-1 from baseline (week 0) up to week 26. HDL-C, TG, and Apo A-1 were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Day 4 (n = 9)
|
-14.37 Percent Change
Standard Deviation 10.830
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 1 (n = 9)
|
-23.34 Percent Change
Standard Deviation 10.783
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 2 (n = 9)
|
-28.75 Percent Change
Standard Deviation 8.458
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 3 (n = 9)
|
-36.96 Percent Change
Standard Deviation 16.495
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 4 (n = 9)
|
-35.24 Percent Change
Standard Deviation 16.212
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 5 (n = 8)
|
-29.74 Percent Change
Standard Deviation 14.240
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 6 (n = 9)
|
-37.88 Percent Change
Standard Deviation 15.864
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 8 (n = 9)
|
-25.42 Percent Change
Standard Deviation 23.199
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 10 (n = 9)
|
-24.57 Percent Change
Standard Deviation 22.409
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 12 (n = 9)
|
-13.59 Percent Change
Standard Deviation 23.189
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 13 (n = 2)
|
-24.48 Percent Change
Standard Deviation 6.243
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 14 (n = 9)
|
-16.81 Percent Change
Standard Deviation 14.822
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 15 (n = 2)
|
-26.97 Percent Change
Standard Deviation 4.895
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 16 (n = 9)
|
-12.03 Percent Change
Standard Deviation 16.026
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 17 (n = 2)
|
-28.34 Percent Change
Standard Deviation 8.393
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 18 (n = 7)
|
-1.05 Percent Change
Standard Deviation 24.171
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 20 (n = 2)
|
-25.39 Percent Change
Standard Deviation 22.187
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 22 (n = 7)
|
3.78 Percent Change
Standard Deviation 20.466
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 23 (n = 2)
|
-11.56 Percent Change
Standard Deviation 12.094
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 25 (n = 2)
|
8.41 Percent Change
Standard Deviation 12.698
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
HDL-C: Percent Change at Week 26 (n = 6)
|
-12.00 Percent Change
Standard Deviation 11.109
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Day 4 (n = 9)
|
-29.61 Percent Change
Standard Deviation 18.562
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 1 (n = 9)
|
-23.41 Percent Change
Standard Deviation 20.150
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 2 (n = 9)
|
-17.19 Percent Change
Standard Deviation 18.735
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 3 (n = 9)
|
-44.38 Percent Change
Standard Deviation 19.223
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 4 (n = 9)
|
-46.57 Percent Change
Standard Deviation 17.014
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 5 (n = 8)
|
-44.49 Percent Change
Standard Deviation 16.583
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 6 (n = 9)
|
-40.03 Percent Change
Standard Deviation 26.830
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 8 (n = 9)
|
-30.69 Percent Change
Standard Deviation 24.800
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 10 (n = 9)
|
-31.40 Percent Change
Standard Deviation 16.697
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 12 (n = 9)
|
-35.38 Percent Change
Standard Deviation 25.014
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 13 (n = 2)
|
-35.11 Percent Change
Standard Deviation 26.733
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 14 (n = 9)
|
-23.51 Percent Change
Standard Deviation 28.335
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 15 (n = 2)
|
-27.77 Percent Change
Standard Deviation 55.240
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 16 (n = 9)
|
-6.70 Percent Change
Standard Deviation 40.326
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 17 (n = 2)
|
-42.09 Percent Change
Standard Deviation 22.941
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 18 (n = 7)
|
23.13 Percent Change
Standard Deviation 55.349
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 20 (n = 2)
|
-26.30 Percent Change
Standard Deviation 11.945
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 22 (n = 7)
|
8.86 Percent Change
Standard Deviation 43.819
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 23 (n = 2)
|
-30.58 Percent Change
Standard Deviation 6.662
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 25 (n = 2)
|
-13.62 Percent Change
Standard Deviation 21.582
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
TG: Percent Change at Week 26 (n = 6)
|
-1.60 Percent Change
Standard Deviation 33.318
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Percent Change at Week 2 (n = 9)
|
-24.37 Percent Change
Standard Deviation 12.794
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Percent Change at Week 3 (n = 9)
|
-36.47 Percent Change
Standard Deviation 16.930
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Percent Change at Week 4 (n = 9)
|
-38.54 Percent Change
Standard Deviation 8.906
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Percent Change at Week 5 (n = 8)
|
-31.91 Percent Change
Standard Deviation 11.491
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Percent Change at Week 6 (n = 9)
|
-34.72 Percent Change
Standard Deviation 12.342
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Percent Change at Week 8 (n = 9)
|
-29.03 Percent Change
Standard Deviation 14.765
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Percent Change at Week 12 (n = 9)
|
-11.85 Percent Change
Standard Deviation 25.176
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Percent Change at Week 14 (n = 9)
|
-17.65 Percent Change
Standard Deviation 13.824
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Percent Change at Week 16 (n = 9)
|
-9.86 Percent Change
Standard Deviation 14.372
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Percent Change at Week 18 (n = 7)
|
-1.16 Percent Change
Standard Deviation 19.598
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Percent Change at Week 20 (n = 2)
|
-22.15 Percent Change
Standard Deviation 7.965
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Percent Change at Week 22 (n = 7)
|
4.21 Percent Change
Standard Deviation 17.857
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Percent Change at Week 23 (n = 2)
|
-21.22 Percent Change
Standard Deviation 7.959
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Apo A-1: Percent Change at Week 26 (n = 6)
|
-9.68 Percent Change
Standard Deviation 11.250
|
SECONDARY outcome
Timeframe: Baseline (Week 26) up to Week 214Population: "n" = Number of participants who were evaluable for this endpoint at a given time point.
Percent change was reported in HDL-C, TG and Apo A-1 from baseline (week 26) up to week 214. HDL-C, TG and Apo A-1 were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=8 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 27 (n= 8)
|
-21.47 Percent change
Standard Deviation 11.815
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 28 (n= 8)
|
-27.60 Percent change
Standard Deviation 11.485
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 29 (n= 8)
|
-26.51 Percent change
Standard Deviation 16.584
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 30 (n= 7)
|
-27.57 Percent change
Standard Deviation 14.566
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 31 (n= 8)
|
-32.81 Percent change
Standard Deviation 18.939
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 32 (n= 8)
|
-32.72 Percent change
Standard Deviation 14.684
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 34 (n= 8)
|
-34.60 Percent change
Standard Deviation 15.971
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 36 (n= 8)
|
-31.14 Percent change
Standard Deviation 18.695
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 38 (n= 8)
|
-18.57 Percent change
Standard Deviation 15.411
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 39 (n= 6)
|
-32.09 Percent change
Standard Deviation 16.062
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 40 (n= 6)
|
-36.25 Percent change
Standard Deviation 9.327
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 41 (n= 6)
|
-39.14 Percent change
Standard Deviation 13.804
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 42 (n= 6)
|
-38.31 Percent change
Standard Deviation 10.670
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 44 (n= 8)
|
-37.01 Percent change
Standard Deviation 12.049
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 46 (n= 8)
|
-32.77 Percent change
Standard Deviation 13.829
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 50 (n= 8)
|
-25.17 Percent change
Standard Deviation 17.957
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 54 (n= 8)
|
-20.16 Percent change
Standard Deviation 18.657
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 58 (n= 6)
|
-10.87 Percent change
Standard Deviation 14.194
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 70 (n= 4)
|
-24.67 Percent change
Standard Deviation 15.473
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 82 (n= 4)
|
-17.56 Percent change
Standard Deviation 10.574
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 94 (n= 1)
|
-13.95 Percent change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at Week 106 (n= 1)
|
0.00 Percent change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at ET (n= 8)
|
-15.08 Percent change
Standard Deviation 21.569
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at EOS (n= 3)
|
-0.78 Percent change
Standard Deviation 27.385
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 27 (n= 8)
|
-38.62 Percent change
Standard Deviation 26.036
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 28 (n= 8)
|
-41.76 Percent change
Standard Deviation 27.247
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 29 (n= 8)
|
-41.17 Percent change
Standard Deviation 18.721
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 30 (n= 7)
|
-38.82 Percent change
Standard Deviation 23.649
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 31 (n= 8)
|
-44.86 Percent change
Standard Deviation 28.212
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 32 (n= 8)
|
-45.33 Percent change
Standard Deviation 23.671
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 34 (n= 8)
|
-28.58 Percent change
Standard Deviation 23.643
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 36 (n= 8)
|
-25.89 Percent change
Standard Deviation 36.606
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 38 (n= 8)
|
-24.32 Percent change
Standard Deviation 25.386
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 39 (n= 6)
|
-48.37 Percent change
Standard Deviation 26.457
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 40 (n= 6)
|
-43.36 Percent change
Standard Deviation 26.527
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 41 (n= 6)
|
-46.65 Percent change
Standard Deviation 25.386
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 42 (n= 6)
|
-43.09 Percent change
Standard Deviation 29.631
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 44 (n= 8)
|
-47.98 Percent change
Standard Deviation 35.076
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 46 (n= 8)
|
-37.64 Percent change
Standard Deviation 26.234
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 50 (n= 8)
|
-22.10 Percent change
Standard Deviation 27.247
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 54 (n= 8)
|
-1.08 Percent change
Standard Deviation 30.518
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 58 (n= 6)
|
3.72 Percent change
Standard Deviation 25.130
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 70 (n= 4)
|
-22.28 Percent change
Standard Deviation 31.761
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 82 (n= 4)
|
-36.47 Percent change
Standard Deviation 9.998
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 94 (n= 1)
|
-76.36 Percent change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at Week 106 (n= 1)
|
-57.98 Percent change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at ET (n= 8)
|
-14.52 Percent change
Standard Deviation 25.892
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Percent change at EOS (n= 3)
|
30.98 Percent change
Standard Deviation 40.511
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Percent change at Week 30 (n= 7)
|
-27.20 Percent change
Standard Deviation 12.119
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Percent change at Week 34 (n= 8)
|
-29.05 Percent change
Standard Deviation 17.483
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Percent change at Week 38 (n= 8)
|
-11.79 Percent change
Standard Deviation 23.939
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Percent change at Week 42 (n= 6)
|
-35.47 Percent change
Standard Deviation 9.512
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Percent change at Week 44 (n= 8)
|
-34.28 Percent change
Standard Deviation 11.306
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Percent change at Week 50 (n= 8)
|
-21.01 Percent change
Standard Deviation 15.471
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Percent change at Week 70 (n= 4)
|
-25.28 Percent change
Standard Deviation 11.950
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Percent change at Week 82 (n= 4)
|
-18.98 Percent change
Standard Deviation 6.534
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Percent change at Week 94 (n= 1)
|
-22.45 Percent change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Percent change at Week 106 (n= 1)
|
3.06 Percent change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Percent change at ET (n= 8)
|
-9.63 Percent change
Standard Deviation 25.308
|
|
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Percent change at EOS (n= 3)
|
11.27 Percent change
Standard Deviation 25.093
|
SECONDARY outcome
Timeframe: Baseline (Week 26) up to Week 214Population: "n" = Number of participants who were evaluable for this endpoint at a given time point.
Absolute change was reported in HDL-C, TG and Apo A-1 from baseline (week 26) up to week 214. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=8 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 27 (n= 8)
|
-8.78 mg/dL
Standard Deviation 5.736
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 28 (n= 8)
|
-12.08 mg/dL
Standard Deviation 7.244
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 29 (n= 8)
|
-11.44 mg/dL
Standard Deviation 7.858
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 30 (n= 7)
|
-13.29 mg/dL
Standard Deviation 9.270
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 31 (n= 8)
|
-13.94 mg/dL
Standard Deviation 8.655
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 32 (n= 8)
|
-14.11 mg/dL
Standard Deviation 8.163
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 34 (n= 8)
|
-15.10 mg/dL
Standard Deviation 9.167
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 36 (n= 8)
|
-14.14 mg/dL
Standard Deviation 10.426
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 38 (n= 8)
|
-8.89 mg/dL
Standard Deviation 7.513
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 39 (n= 6)
|
-14.02 mg/dL
Standard Deviation 8.023
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 40 (n= 6)
|
-15.90 mg/dL
Standard Deviation 7.171
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 41 (n= 6)
|
-17.17 mg/dL
Standard Deviation 8.262
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 42 (n= 6)
|
-16.65 mg/dL
Standard Deviation 7.148
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 44 (n= 8)
|
-15.83 mg/dL
Standard Deviation 8.167
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 46 (n= 8)
|
-14.85 mg/dL
Standard Deviation 10.173
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 50 (n= 8)
|
-12.25 mg/dL
Standard Deviation 10.985
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 54 (n= 8)
|
-9.06 mg/dL
Standard Deviation 9.107
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 58 (n= 6)
|
-5.42 mg/dL
Standard Deviation 6.058
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 70 (n= 4)
|
-10.83 mg/dL
Standard Deviation 10.448
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 82 (n= 4)
|
-6.28 mg/dL
Standard Deviation 2.655
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 94 (n= 1)
|
-4.20 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at Week 106 (n= 1)
|
0.00 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Percent change at ET (n= 8)
|
-7.86 mg/dL
Standard Deviation 8.258
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
HDL-C: Change at EOS (n= 3)
|
-1.67 mg/dL
Standard Deviation 10.698
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 27 (n= 8)
|
-31.19 mg/dL
Standard Deviation 28.590
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 28 (n= 8)
|
-36.28 mg/dL
Standard Deviation 30.630
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 29 (n= 8)
|
-32.86 mg/dL
Standard Deviation 25.188
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 30 (n= 7)
|
-32.37 mg/dL
Standard Deviation 30.475
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 31 (n= 8)
|
-39.04 mg/dL
Standard Deviation 30.169
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 32 (n= 8)
|
-37.83 mg/dL
Standard Deviation 30.808
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 34 (n= 8)
|
-25.41 mg/dL
Standard Deviation 26.559
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 36 (n= 8)
|
-24.66 mg/dL
Standard Deviation 28.139
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 38 (n= 8)
|
-21.13 mg/dL
Standard Deviation 25.190
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 39 (n= 6)
|
-40.27 mg/dL
Standard Deviation 32.803
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 40 (n= 6)
|
-37.30 mg/dL
Standard Deviation 33.559
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 41 (n= 6)
|
-39.37 mg/dL
Standard Deviation 33.251
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 42 (n= 6)
|
-37.62 mg/dL
Standard Deviation 33.724
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 44 (n= 8)
|
-42.25 mg/dL
Standard Deviation 32.682
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 46 (n= 8)
|
-31.53 mg/dL
Standard Deviation 28.209
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 50 (n= 8)
|
-20.00 mg/dL
Standard Deviation 27.720
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 54 (n= 8)
|
-6.40 mg/dL
Standard Deviation 26.869
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 58 (n= 6)
|
-3.53 mg/dL
Standard Deviation 21.753
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 70 (n= 4)
|
-21.23 mg/dL
Standard Deviation 35.614
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 82 (n= 4)
|
-26.33 mg/dL
Standard Deviation 21.457
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 94 (n= 1)
|
-88.50 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at Week 106 (n= 1)
|
-67.20 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at ET (n= 8)
|
-11.71 mg/dL
Standard Deviation 21.343
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Triglycerides: Change at EOS (n= 3)
|
30.67 mg/dL
Standard Deviation 35.390
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Change at Week 30 (n= 7)
|
-34.4 mg/dL
Standard Deviation 20.18
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Change at Week 34 (n= 8)
|
-35.1 mg/dL
Standard Deviation 24.70
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Change at Week 38 (n= 8)
|
-18.0 mg/dL
Standard Deviation 26.54
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Change at Week 42 (n= 6)
|
-43.7 mg/dL
Standard Deviation 15.71
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Change at Week 44 (n= 8)
|
-39.4 mg/dL
Standard Deviation 18.12
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Change at Week 50 (n= 8)
|
-26.9 mg/dL
Standard Deviation 23.56
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Change at Week 70 (n= 4)
|
-30.3 mg/dL
Standard Deviation 20.12
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Change at Week 82 (n= 4)
|
-21.0 mg/dL
Standard Deviation 5.83
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Change at Week 94 (n= 1)
|
-22.0 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Change at Week 106 (n= 1)
|
3.0 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Change at ET (n= 8)
|
-15.6 mg/dL
Standard Deviation 24.34
|
|
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Apo A-1: Change at EOS (n= 3)
|
7.0 mg/dL
Standard Deviation 24.98
|
SECONDARY outcome
Timeframe: Baseline (Week 0) up to Week 16Population: "n" = Number of participants who were evaluable for this endpoint at a given time point.
Absolute change was reported in Apo CIII from baseline (week 0) up to week 16. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Apo CIII: Change at Day 4 (n = 9)
|
-3.729 mg/dL
Standard Deviation 1.6905
|
|
Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Apo CIII: Change at Week 1 (n = 9)
|
-4.296 mg/dL
Standard Deviation 1.9829
|
|
Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Apo CIII: Change at Week 2 (n = 9)
|
-4.301 mg/dL
Standard Deviation 2.2542
|
|
Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Apo CIII: Change at Week 5 (n = 8)
|
-6.000 mg/dL
Standard Deviation 2.8541
|
|
Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Apo CIII: Change at Week 6 (n = 1)
|
-8.380 mg/dL
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Apo CIII: Change at Week 12 (n = 9)
|
-3.772 mg/dL
Standard Deviation 2.8443
|
|
Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Apo CIII: Change at Week 14 (n = 9)
|
-3.866 mg/dL
Standard Deviation 3.7327
|
|
Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Apo CIII: Change at Week 16 (n = 9)
|
-2.757 mg/dL
Standard Deviation 4.4877
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 16Population: "n" = Number of participants who were evaluable for this endpoint at a given time point.
Percent change was reported in Apo CIII from baseline (week 0) up to week 16. Apo CIII was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period.
Outcome measures
| Measure |
REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 Participants
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
|---|---|
|
Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Apo CIII: Percent Change at Day 4 (n = 9)
|
-46.59 Percent Change
Standard Deviation 22.129
|
|
Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Apo CIII: Percent Change at Week 1 (n = 9)
|
-55.43 Percent Change
Standard Deviation 18.541
|
|
Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Apo CIII: Percent Change at Week 2 (n = 9)
|
-56.57 Percent Change
Standard Deviation 24.815
|
|
Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Apo CIII: Percent Change at Week 5 (n = 8)
|
-75.44 Percent Change
Standard Deviation 9.667
|
|
Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Apo CIII: Percent Change at Week 6 (n = 1)
|
-91.48 Percent Change
Standard Deviation NA
NA = Standard deviation cannot be calculated for n = 1.
|
|
Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Apo CIII: Percent Change at Week 12 (n = 9)
|
-49.07 Percent Change
Standard Deviation 25.517
|
|
Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Apo CIII: Percent Change at Week 14 (n = 9)
|
-40.67 Percent Change
Standard Deviation 44.674
|
|
Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Apo CIII: Percent Change at Week 16 (n = 9)
|
-28.30 Percent Change
Standard Deviation 54.676
|
Adverse Events
Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
OLE Period: REGN1500 300 mg SC/20 mg/kg IV
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 participants at risk
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
OLE Period: REGN1500 300 mg SC/20 mg/kg IV
n=8 participants at risk
Participants received REGN1500 a SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 \[Day 1499\]) after the last dose of study drug in the OLE treatment period.
|
|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
Other adverse events
| Measure |
Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
n=9 participants at risk
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
|
OLE Period: REGN1500 300 mg SC/20 mg/kg IV
n=8 participants at risk
Participants received REGN1500 a SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 \[Day 1499\]) after the last dose of study drug in the OLE treatment period.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Eye disorders
Corneal opacity
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Eye disorders
Eye inflammation
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 2 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Number of events 2 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
50.0%
4/8 • Number of events 6 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Gastrointestinal disorders
Faeces discoloured
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Number of events 6 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
37.5%
3/8 • Number of events 5 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
General disorders
Chest discomfort
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
General disorders
Chest pain
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
General disorders
Fatigue
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
General disorders
Injection site haematoma
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
General disorders
Influenza like illness
|
22.2%
2/9 • Number of events 3 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
25.0%
2/8 • Number of events 2 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
General disorders
Injection site haemorrhage
|
11.1%
1/9 • Number of events 2 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
General disorders
Local swelling
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
General disorders
Oedema peripheral
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
General disorders
Pyrexia
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Immune system disorders
Food allergy
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 2 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Infections and infestations
Gastroenteritis
|
11.1%
1/9 • Number of events 2 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Infections and infestations
Nasopharyngitis
|
22.2%
2/9 • Number of events 3 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
37.5%
3/8 • Number of events 4 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Infections and infestations
Pharyngitis
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Infections and infestations
Sinusitis
|
11.1%
1/9 • Number of events 2 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
25.0%
2/8 • Number of events 2 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
25.0%
2/8 • Number of events 3 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Injury, poisoning and procedural complications
Crush injury
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Investigations
Blood creatine phosphokinase increased
|
11.1%
1/9 • Number of events 3 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 2 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Investigations
Crystal urine present
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Investigations
Liver function test abnormal
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Investigations
Transaminases increased
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
44.4%
4/9 • Number of events 6 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
50.0%
4/8 • Number of events 8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
22.2%
2/9 • Number of events 2 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
25.0%
2/8 • Number of events 3 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.2%
2/9 • Number of events 2 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway cough syndrome
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
11.1%
1/9 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 1 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
12.5%
1/8 • Number of events 3 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
|
Vascular disorders
Flushing
|
11.1%
1/9 • Number of events 2 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
0.00%
0/8 • All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
|
Additional Information
Clinical Trial Information
Regeneron Pharmaceuticals, Inc.
Phone: 844-734-6643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER