Trial Outcomes & Findings for A Study of LY3015014 in Participants With High Cholesterol (NCT NCT01890967)
NCT ID: NCT01890967
Last Updated: 2019-09-18
Results Overview
Least square (LS) Means was calculated using analysis of covariance (ANCOVA) adjusted for disease classification, statin dose, baseline LDL-C measurement. Percent change from baseline response is the dependent variable.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
527 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2019-09-18
Participant Flow
Participant milestones
| Measure |
Placebo Q4W
Placebo given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
20 mg LY3015014 Q4W
20 milligrams (mg) LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
120 mg LY3015014 Q4W
120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q4W
300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
100 mg LY3015014 Q8W
100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q8W
300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
88
|
88
|
88
|
88
|
87
|
88
|
|
Overall Study
Received at Least One Dose of Study Drug
|
87
|
87
|
86
|
86
|
86
|
87
|
|
Overall Study
COMPLETED
|
78
|
77
|
78
|
77
|
77
|
75
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
10
|
11
|
10
|
13
|
Reasons for withdrawal
| Measure |
Placebo Q4W
Placebo given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
20 mg LY3015014 Q4W
20 milligrams (mg) LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
120 mg LY3015014 Q4W
120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q4W
300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
100 mg LY3015014 Q8W
100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q8W
300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
3
|
2
|
1
|
7
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
3
|
3
|
2
|
4
|
1
|
|
Overall Study
Sponsor Decision
|
2
|
0
|
1
|
3
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
2
|
3
|
3
|
1
|
Baseline Characteristics
A Study of LY3015014 in Participants With High Cholesterol
Baseline characteristics by cohort
| Measure |
Placebo Q4W
n=87 Participants
Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
20 mg LY3015014 Q4W
n=87 Participants
20 mg LY3015014 given subcutaneously SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
120 mg LY3015014 Q4W
n=86 Participants
120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q4W
n=86 Participants
300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
100 mg LY3015014 Q8W
n=86 Participants
100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q8W
n=87 Participants
300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
Total
n=519 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.9 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
57.2 Years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
57.1 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
59.7 Years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
59.6 Years
STANDARD_DEVIATION 8.1 • n=21 Participants
|
58.7 Years
STANDARD_DEVIATION 10.1 • n=8 Participants
|
58.4 Years
STANDARD_DEVIATION 10.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
43 Participants
n=8 Participants
|
241 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
278 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
315 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
191 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
137 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
58 Participants
n=8 Participants
|
356 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
94 Participants
n=8 Participants
|
|
Region of Enrollment
Netherlands
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
88 Participants
n=8 Participants
|
|
Region of Enrollment
Czech Republic
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
143 Participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
106 Participants
n=8 Participants
|
|
Region of Enrollment
Denmark
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
|
Region of Enrollment
Poland
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
|
Serum LDL Cholesterol Beta Quantification
|
136.5 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 39.6 • n=5 Participants
|
134.1 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 42.4 • n=7 Participants
|
134.0 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 40.7 • n=5 Participants
|
132.1 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 42.3 • n=4 Participants
|
135.2 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 41.2 • n=21 Participants
|
146.0 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 60.5 • n=8 Participants
|
136.3 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 45.0 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: Modified Intent to Treat (mITT) is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.
Least square (LS) Means was calculated using analysis of covariance (ANCOVA) adjusted for disease classification, statin dose, baseline LDL-C measurement. Percent change from baseline response is the dependent variable.
Outcome measures
| Measure |
Placebo Q4W
n=79 Participants
Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
20 mg LY3015014 Q4W
n=75 Participants
20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
120 mg LY3015014 Q4W
n=78 Participants
120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q4W
n=76 Participants
300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
100 mg LY3015014 Q8W
n=73 Participants
100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q8W
n=73 Participants
300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
|
7.6 Percentage change
Standard Error 2.27
|
-14.9 Percentage change
Standard Error 2.39
|
-40.5 Percentage change
Standard Error 2.31
|
-50.5 Percentage change
Standard Error 2.30
|
-14.9 Percentage change
Standard Error 2.35
|
-37.1 Percentage change
Standard Error 2.44
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.
LS Mean was calculated using mixed model repeated measures (MMRM) analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.
Outcome measures
| Measure |
Placebo Q4W
n=86 Participants
Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
20 mg LY3015014 Q4W
n=86 Participants
20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
120 mg LY3015014 Q4W
n=86 Participants
120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q4W
n=85 Participants
300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
100 mg LY3015014 Q8W
n=86 Participants
100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q8W
n=87 Participants
300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C
LDL-C
|
5.9 Percentage change
Standard Error 2.13
|
-18.0 Percentage change
Standard Error 2.18
|
-46.4 Percentage change
Standard Error 2.15
|
-56.5 Percentage change
Standard Error 2.14
|
-18.4 Percentage change
Standard Error 2.14
|
-42.2 Percentage change
Standard Error 2.21
|
|
Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C
TG
|
3.5 Percentage change
Standard Error 3.26
|
-6.1 Percentage change
Standard Error 3.35
|
-7.2 Percentage change
Standard Error 3.25
|
-15.1 Percentage change
Standard Error 3.26
|
-7.2 Percentage change
Standard Error 3.29
|
-10.6 Percentage change
Standard Error 3.35
|
|
Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C
TC
|
3.5 Percentage change
Standard Error 1.44
|
-10.5 Percentage change
Standard Error 1.47
|
-27.8 Percentage change
Standard Error 1.44
|
-34.1 Percentage change
Standard Error 1.44
|
-11.0 Percentage change
Standard Error 1.45
|
-24.6 Percentage change
Standard Error 1.48
|
|
Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C
HDL-C
|
1.6 Percentage change
Standard Error 1.58
|
4.5 Percentage change
Standard Error 1.60
|
7.3 Percentage change
Standard Error 1.57
|
8.8 Percentage change
Standard Error 1.58
|
4.5 Percentage change
Standard Error 1.59
|
8.4 Percentage change
Standard Error 1.61
|
|
Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C
Non-HDL-C
|
4.9 Percentage change
Standard Error 1.83
|
-16.1 Percentage change
Standard Error 1.86
|
-39.3 Percentage change
Standard Error 1.83
|
-48.9 Percentage change
Standard Error 1.83
|
-16.1 Percentage change
Standard Error 1.84
|
-35.8 Percentage change
Standard Error 1.88
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.
LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.
Outcome measures
| Measure |
Placebo Q4W
n=86 Participants
Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
20 mg LY3015014 Q4W
n=84 Participants
20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
120 mg LY3015014 Q4W
n=84 Participants
120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q4W
n=85 Participants
300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
100 mg LY3015014 Q8W
n=85 Participants
100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q8W
n=87 Participants
300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)
Apo B
|
4.2 Percentage change
Standard Error 2.23
|
-16.6 Percentage change
Standard Error 2.32
|
-34.9 Percentage change
Standard Error 2.28
|
-46.8 Percentage change
Standard Error 2.25
|
-16.0 Percentage change
Standard Error 2.25
|
-31.9 Percentage change
Standard Error 2.31
|
|
Percentage Change From Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)
Apo A1
|
0.3 Percentage change
Standard Error 1.40
|
2.4 Percentage change
Standard Error 1.43
|
6.5 Percentage change
Standard Error 1.41
|
6.2 Percentage change
Standard Error 1.41
|
3.8 Percentage change
Standard Error 1.43
|
5.8 Percentage change
Standard Error 1.44
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.
Data was log-transformed for MMRM analysis, with change from baseline as the dependent variable, and baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included as independent variables. Percentage change from baseline in the original scale was then back-calculated from the log-transformed MMRM analysis.
Outcome measures
| Measure |
Placebo Q4W
n=68 Participants
Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
20 mg LY3015014 Q4W
n=71 Participants
20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
120 mg LY3015014 Q4W
n=73 Participants
120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q4W
n=75 Participants
300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
100 mg LY3015014 Q8W
n=70 Participants
100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q8W
n=68 Participants
300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Lipoprotein(a) [Lp(a)]
|
-0.31 Percentage Change
Standard Error 0.0436
|
-16.63 Percentage Change
Standard Error 0.0442
|
-19.02 Percentage Change
Standard Error 0.0427
|
-37.29 Percentage Change
Standard Error 0.0420
|
-7.54 Percentage Change
Standard Error 0.0427
|
-21.01 Percentage Change
Standard Error 0.0437
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.
LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.
Outcome measures
| Measure |
Placebo Q4W
n=78 Participants
Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
20 mg LY3015014 Q4W
n=75 Participants
20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
120 mg LY3015014 Q4W
n=80 Participants
120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q4W
n=78 Participants
300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
100 mg LY3015014 Q8W
n=76 Participants
100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q8W
n=73 Participants
300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)
|
0.5 Percentage change
Standard Error 0.70
|
-0.2 Percentage change
Standard Error 0.72
|
1.6 Percentage change
Standard Error 0.69
|
-0.3 Percentage change
Standard Error 0.70
|
-0.3 Percentage change
Standard Error 0.70
|
-0.7 Percentage change
Standard Error 0.72
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: All randomized participants who received at least one dose of study treatment and had evaluable data.
Outcome measures
| Measure |
Placebo Q4W
n=86 Participants
Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
20 mg LY3015014 Q4W
n=86 Participants
20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
120 mg LY3015014 Q4W
n=86 Participants
120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q4W
n=85 Participants
300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
100 mg LY3015014 Q8W
n=86 Participants
100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q8W
n=87 Participants
300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies
|
4 Participants
|
6 Participants
|
10 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.
LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.
Outcome measures
| Measure |
Placebo Q4W
n=77 Participants
Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
20 mg LY3015014 Q4W
n=76 Participants
20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
120 mg LY3015014 Q4W
n=79 Participants
120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q4W
n=79 Participants
300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
100 mg LY3015014 Q8W
n=75 Participants
100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q8W
n=75 Participants
300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Total Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels
|
14.6 Percentage change
Standard Error 13.66
|
9.1 Percentage change
Standard Error 14.00
|
86.4 Percentage change
Standard Error 13.65
|
130.6 Percentage change
Standard Error 13.63
|
21.8 Percentage change
Standard Error 13.63
|
41.0 Percentage change
Standard Error 13.63
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.
LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.
Outcome measures
| Measure |
Placebo Q4W
n=77 Participants
Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
20 mg LY3015014 Q4W
n=72 Participants
20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
120 mg LY3015014 Q4W
n=76 Participants
120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q4W
n=75 Participants
300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
100 mg LY3015014 Q8W
n=70 Participants
100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q8W
n=72 Participants
300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Free Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels
|
9.9 Percentage change
Standard Error 5.59
|
-16.3 Percentage change
Standard Error 5.81
|
-36.6 Percentage change
Standard Error 5.67
|
-68.0 Percentage change
Standard Error 5.71
|
-4.4 Percentage change
Standard Error 5.80
|
-35.2 Percentage change
Standard Error 5.72
|
SECONDARY outcome
Timeframe: Week 12-16 (Q4W) - Predose, Week 8-16 (Q8W) - PredosePopulation: All randomly assigned participants who received at least one dose of the study medication and had evaluable data.
Outcome measures
| Measure |
Placebo Q4W
n=83 Participants
Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
20 mg LY3015014 Q4W
n=85 Participants
20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
120 mg LY3015014 Q4W
n=82 Participants
120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q4W
n=84 Participants
300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
100 mg LY3015014 Q8W
n=86 Participants
100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q8W
300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady-State (AUC,ss) for LY3015014
|
1590 μg∙hr/mL
Geometric Coefficient of Variation 29.2
|
9670 μg∙hr/mL
Geometric Coefficient of Variation 29.9
|
27300 μg∙hr/mL
Geometric Coefficient of Variation 26.3
|
7800 μg∙hr/mL
Geometric Coefficient of Variation 28.5
|
26600 μg∙hr/mL
Geometric Coefficient of Variation 32.2
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: All randomized participants who received at least one dose of study treatment and had evaluable data.
Outcome measures
| Measure |
Placebo Q4W
n=87 Participants
Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
20 mg LY3015014 Q4W
n=87 Participants
20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
120 mg LY3015014 Q4W
n=86 Participants
120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q4W
n=86 Participants
300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
100 mg LY3015014 Q8W
n=86 Participants
100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q8W
n=87 Participants
300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
|---|---|---|---|---|---|---|
|
Number of Participants With an Injection Site Reaction
|
26 Participants
|
42 Participants
|
57 Participants
|
51 Participants
|
36 Participants
|
41 Participants
|
Adverse Events
Placebo Q4W
Serious events: 5 serious events
Other events: 63 other events
Deaths: 0 deaths
20 mg LY3015014 Q4W
Serious events: 3 serious events
Other events: 69 other events
Deaths: 0 deaths
120 mg LY3015014 Q4W
Serious events: 6 serious events
Other events: 64 other events
Deaths: 0 deaths
300 mg LY3015014 Q4W
Serious events: 2 serious events
Other events: 64 other events
Deaths: 0 deaths
100 mg LY3015014 Q8W
Serious events: 2 serious events
Other events: 64 other events
Deaths: 0 deaths
300 mg LY3015014 Q8W
Serious events: 4 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Q4W
n=87 participants at risk
Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
20 mg LY3015014 Q4W
n=87 participants at risk
20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
120 mg LY3015014 Q4W
n=86 participants at risk
120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q4W
n=86 participants at risk
300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
100 mg LY3015014 Q8W
n=86 participants at risk
100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q8W
n=87 participants at risk
300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
1.2%
1/86 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
1.2%
1/86 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
1.2%
1/86 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
1.2%
1/86 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
1.2%
1/86 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
1.2%
1/86 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningeal neoplasm
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
1.2%
1/86 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/47
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/45
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/45
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/47
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/50
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
1/44 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
1.2%
1/86 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Loss of consciousness
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/40
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/42
Participants at Risk included all participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/39
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/36
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/43
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
1.2%
1/86 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
1.2%
1/86 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo Q4W
n=87 participants at risk
Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
20 mg LY3015014 Q4W
n=87 participants at risk
20 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
120 mg LY3015014 Q4W
n=86 participants at risk
120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q4W
n=86 participants at risk
300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
100 mg LY3015014 Q8W
n=86 participants at risk
100 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
300 mg LY3015014 Q8W
n=87 participants at risk
300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
2/87 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
6.9%
6/87 • Number of events 9
Participants at Risk included all participants who received at least one dose of study drug.
|
7.0%
6/86 • Number of events 6
Participants at Risk included all participants who received at least one dose of study drug.
|
3.5%
3/86 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
3.5%
3/86 • Number of events 4
Participants at Risk included all participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
4.6%
4/87 • Number of events 4
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
7.0%
6/86 • Number of events 6
Participants at Risk included all participants who received at least one dose of study drug.
|
3.5%
3/86 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
3.5%
3/86 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
6.9%
6/87 • Number of events 8
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
2/87 • Number of events 2
Participants at Risk included all participants who received at least one dose of study drug.
|
1.2%
1/86 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
1.2%
1/86 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
1.2%
1/86 • Number of events 2
Participants at Risk included all participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
|
General disorders
Injection site bruising
|
4.6%
4/87 • Number of events 4
Participants at Risk included all participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
9.3%
8/86 • Number of events 9
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
2/86 • Number of events 2
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
2/86 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
4.6%
4/87 • Number of events 4
Participants at Risk included all participants who received at least one dose of study drug.
|
|
General disorders
Injection site erythema
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
10.5%
9/86 • Number of events 10
Participants at Risk included all participants who received at least one dose of study drug.
|
8.1%
7/86 • Number of events 10
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
2/86 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
3.4%
3/87 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
|
General disorders
Injection site pain
|
3.4%
3/87 • Number of events 6
Participants at Risk included all participants who received at least one dose of study drug.
|
17.2%
15/87 • Number of events 20
Participants at Risk included all participants who received at least one dose of study drug.
|
12.8%
11/86 • Number of events 17
Participants at Risk included all participants who received at least one dose of study drug.
|
9.3%
8/86 • Number of events 17
Participants at Risk included all participants who received at least one dose of study drug.
|
8.1%
7/86 • Number of events 13
Participants at Risk included all participants who received at least one dose of study drug.
|
10.3%
9/87 • Number of events 12
Participants at Risk included all participants who received at least one dose of study drug.
|
|
General disorders
Injection site pruritus
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
4.6%
4/87 • Number of events 6
Participants at Risk included all participants who received at least one dose of study drug.
|
7.0%
6/86 • Number of events 6
Participants at Risk included all participants who received at least one dose of study drug.
|
9.3%
8/86 • Number of events 13
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
2/86 • Number of events 2
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
2/87 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
5.8%
5/86 • Number of events 7
Participants at Risk included all participants who received at least one dose of study drug.
|
7.0%
6/86 • Number of events 10
Participants at Risk included all participants who received at least one dose of study drug.
|
3.5%
3/86 • Number of events 4
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
2/87 • Number of events 2
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
5.7%
5/87 • Number of events 6
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
2/86 • Number of events 2
Participants at Risk included all participants who received at least one dose of study drug.
|
3.5%
3/86 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
2/86 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
3.4%
3/87 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
3.4%
3/87 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
5.7%
5/87 • Number of events 5
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
2/86 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
3.5%
3/86 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
2/86 • Number of events 2
Participants at Risk included all participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 2
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
17.2%
15/87 • Number of events 17
Participants at Risk included all participants who received at least one dose of study drug.
|
23.0%
20/87 • Number of events 23
Participants at Risk included all participants who received at least one dose of study drug.
|
25.6%
22/86 • Number of events 22
Participants at Risk included all participants who received at least one dose of study drug.
|
16.3%
14/86 • Number of events 18
Participants at Risk included all participants who received at least one dose of study drug.
|
12.8%
11/86 • Number of events 13
Participants at Risk included all participants who received at least one dose of study drug.
|
17.2%
15/87 • Number of events 18
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.6%
4/87 • Number of events 4
Participants at Risk included all participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 2
Participants at Risk included all participants who received at least one dose of study drug.
|
5.8%
5/86 • Number of events 5
Participants at Risk included all participants who received at least one dose of study drug.
|
8.1%
7/86 • Number of events 8
Participants at Risk included all participants who received at least one dose of study drug.
|
7.0%
6/86 • Number of events 7
Participants at Risk included all participants who received at least one dose of study drug.
|
5.7%
5/87 • Number of events 5
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
5/87 • Number of events 5
Participants at Risk included all participants who received at least one dose of study drug.
|
3.4%
3/87 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
3.5%
3/86 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
7.0%
6/86 • Number of events 6
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
2/86 • Number of events 2
Participants at Risk included all participants who received at least one dose of study drug.
|
4.6%
4/87 • Number of events 5
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
3/87 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
4.6%
4/87 • Number of events 6
Participants at Risk included all participants who received at least one dose of study drug.
|
10.5%
9/86 • Number of events 10
Participants at Risk included all participants who received at least one dose of study drug.
|
3.5%
3/86 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
2/86 • Number of events 2
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
2/87 • Number of events 2
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
3/87 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
6.9%
6/87 • Number of events 9
Participants at Risk included all participants who received at least one dose of study drug.
|
7.0%
6/86 • Number of events 8
Participants at Risk included all participants who received at least one dose of study drug.
|
8.1%
7/86 • Number of events 9
Participants at Risk included all participants who received at least one dose of study drug.
|
3.5%
3/86 • Number of events 5
Participants at Risk included all participants who received at least one dose of study drug.
|
6.9%
6/87 • Number of events 6
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
6.9%
6/87 • Number of events 7
Participants at Risk included all participants who received at least one dose of study drug.
|
6.9%
6/87 • Number of events 7
Participants at Risk included all participants who received at least one dose of study drug.
|
12.8%
11/86 • Number of events 13
Participants at Risk included all participants who received at least one dose of study drug.
|
9.3%
8/86 • Number of events 11
Participants at Risk included all participants who received at least one dose of study drug.
|
9.3%
8/86 • Number of events 8
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
2/87 • Number of events 8
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
5/87 • Number of events 5
Participants at Risk included all participants who received at least one dose of study drug.
|
3.4%
3/87 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
5.8%
5/86 • Number of events 6
Participants at Risk included all participants who received at least one dose of study drug.
|
2.3%
2/86 • Number of events 2
Participants at Risk included all participants who received at least one dose of study drug.
|
1.2%
1/86 • Number of events 2
Participants at Risk included all participants who received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1
Participants at Risk included all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/87
Participants at Risk included all participants who received at least one dose of study drug.
|
3.4%
3/87 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
3.5%
3/86 • Number of events 3
Participants at Risk included all participants who received at least one dose of study drug.
|
0.00%
0/86
Participants at Risk included all participants who received at least one dose of study drug.
|
5.8%
5/86 • Number of events 5
Participants at Risk included all participants who received at least one dose of study drug.
|
6.9%
6/87 • Number of events 6
Participants at Risk included all participants who received at least one dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60