Trial Outcomes & Findings for Randomized Study of Obicetrapib as an Adjunct to Statin Therapy (NCT NCT04753606)
NCT ID: NCT04753606
Last Updated: 2024-07-12
Results Overview
Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group.LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
8-weeks
Results posted on
2024-07-12
Participant Flow
195 participants were screened; out of 195, 120 participants were randomized.
Participant milestones
| Measure |
Placebo
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
39
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
Randomized Study of Obicetrapib as an Adjunct to Statin Therapy
Baseline characteristics by cohort
| Measure |
Placebo
n=40 Participants
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 8.77 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 8.13 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 8.43 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Ethnicity (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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Baseline Low-Density Lipoprotein Cholesterol (LDL-C) Values
|
98.6 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 31.09 • n=5 Participants
|
99.2 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 30.95 • n=7 Participants
|
94.2 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 31.14 • n=5 Participants
|
97.33 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 31.06 • n=4 Participants
|
PRIMARY outcome
Timeframe: 8-weeksPopulation: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group.LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),
Outcome measures
| Measure |
Placebo
n=39 Participants
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=39 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
|
-5.48 percent change from baseline
Standard Deviation 23.357
|
-37.97 percent change from baseline
Standard Deviation 27.526
|
-43.35 percent change from baseline
Standard Deviation 19.369
|
PRIMARY outcome
Timeframe: 8-WeeksPopulation: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. \[Friedewald\] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),
Outcome measures
| Measure |
Placebo
n=39 Participants
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=39 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
|
0 percent change from baseline
Interval -57.9 to 40.3
|
-42.90 percent change from baseline
Interval -81.9 to 72.4
|
-45.65 percent change from baseline
Interval -78.0 to 26.2
|
PRIMARY outcome
Timeframe: 8-WeeksPopulation: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
LS mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. \[Friedewald\] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),
Outcome measures
| Measure |
Placebo
n=40 Participants
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
LS Mean Percent Change Iin Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
|
-5.00 percent change from baseline
Standard Error 3.502
|
-37.97 percent change from baseline
Standard Error 3.491
|
-44.18 percent change from baseline
Standard Error 3.461
|
PRIMARY outcome
Timeframe: 8-WeeksPopulation: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Outcome measures
| Measure |
Placebo
n=39 Participants
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=38 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
|
-7.11 percent change from baseline
Standard Deviation 20.773
|
-35.98 percent change from baseline
Standard Deviation 25.469
|
-46.06 percent change from baseline
Standard Deviation 19.393
|
PRIMARY outcome
Timeframe: 8-WeeksPopulation: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Outcome measures
| Measure |
Placebo
n=39 Participants
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=38 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
|
-6.50 percent change from baseline
Interval -53.9 to 31.6
|
-41.45 percent change from baseline
Interval -71.2 to 62.3
|
-50.75 percent change from baseline
Interval -76.9 to 15.6
|
PRIMARY outcome
Timeframe: 8-WeeksPopulation: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
LS Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured directly by preparative ultracentrifugation (PUC).
Outcome measures
| Measure |
Placebo
n=39 Participants
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=38 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
|
-6.70 percent change from baseline
Standard Error 3.263
|
-35.65 percent change from baseline
Standard Error 3.305
|
-46.77 percent change from baseline
Standard Error 3.225
|
SECONDARY outcome
Timeframe: 8-WeeksPopulation: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
Outcome measures
| Measure |
Placebo
n=39 Participants
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=39 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
Mean Percent Change in Apolipoprotein B (ApoB)
|
-4.67 percent change from baseline
Standard Deviation 17.687
|
-22.62 percent change from baseline
Standard Deviation 21.882
|
-27.19 percent change from baseline
Standard Deviation 15.329
|
SECONDARY outcome
Timeframe: 8-WeekPopulation: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
Outcome measures
| Measure |
Placebo
n=39 Participants
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=39 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
Median Percent Change in Apolipoprotein B (ApoB)
|
-2.60 percent change from baseline
Interval -50.0 to 28.4
|
-24.40 percent change from baseline
Interval -58.5 to 47.4
|
-29.75 percent change from baseline
Interval -58.4 to 13.0
|
SECONDARY outcome
Timeframe: 8-WeeksPopulation: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
Outcome measures
| Measure |
Placebo
n=40 Participants
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
LS Mean Percent Change in Apolipoprotein B (ApoB)
|
-4.13 percent change from baseline
Standard Error 2.593
|
-22.40 percent change from baseline
Standard Error 2.582
|
-28.12 percent change from baseline
Standard Error 2.564
|
SECONDARY outcome
Timeframe: 8-weeksPopulation: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Outcome measures
| Measure |
Placebo
n=39 Participants
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=39 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
|
-4.22 percent change from baseline
Standard Deviation 20.440
|
-34.28 percent change from baseline
Standard Deviation 25.623
|
-39.25 percent change from baseline
Standard Deviation 17.625
|
SECONDARY outcome
Timeframe: 8-WeeksPopulation: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
Median percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Outcome measures
| Measure |
Placebo
n=39 Participants
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=39 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
|
-3.50 percent change from baseline
Interval -50.3 to 48.4
|
-38.90 percent change from baseline
Interval -65.6 to 66.3
|
-44.40 percent change from baseline
Interval -70.2 to 22.5
|
SECONDARY outcome
Timeframe: 8-WeeksPopulation: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
LS Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Outcome measures
| Measure |
Placebo
n=40 Participants
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
|
-3.83 percent change from baseline
Standard Error 3.191
|
-34.37 percent change from baseline
Standard Error 3.179
|
-39.86 percent change from baseline
Standard Error 3.153
|
SECONDARY outcome
Timeframe: 8-weeksPopulation: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.
Outcome measures
| Measure |
Placebo
n=39 Participants
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=39 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
|
-6.62 percent change from baseline
Standard Deviation 12.436
|
123.92 percent change from baseline
Standard Deviation 57.671
|
156.41 percent change from baseline
Standard Deviation 52.165
|
SECONDARY outcome
Timeframe: 8-WeeksPopulation: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
Median percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.
Outcome measures
| Measure |
Placebo
n=39 Participants
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=39 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
|
-4.90 percent change from baseline
Interval -30.3 to 28.6
|
135.40 percent change from baseline
Interval -26.4 to 212.9
|
164.95 percent change from baseline
Interval 55.1 to 286.3
|
SECONDARY outcome
Timeframe: 8-WeeksPopulation: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
LS mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.
Outcome measures
| Measure |
Placebo
n=40 Participants
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 Participants
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
|
-6.98 percent change from baseline
Standard Error 6.620
|
122.29 percent change from baseline
Standard Error 6.585
|
157.35 percent change from baseline
Standard Error 6.538
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Obicetrapib 5 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Obicetrapib 10 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=40 participants at risk
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=40 participants at risk
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 participants at risk
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
Nervous system disorders
Transient ischemic attack
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
Other adverse events
| Measure |
Placebo
n=40 participants at risk
once-daily placebo
Obicetrapib: tablets
|
Obicetrapib 5 mg
n=40 participants at risk
once-daily obicetrapib
Obicetrapib: tablets
|
Obicetrapib 10 mg
n=40 participants at risk
once-daily obicetrapib
Obicetrapib: tablets
|
|---|---|---|---|
|
Reproductive system and breast disorders
Pelvic Pain
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
2/40 • Number of events 2 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
Perineal abscess
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Investigations
Lipase increased
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Investigations
Transaminases increased
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
2/40 • Number of events 3 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
5.0%
2/40 • Number of events 2 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
General disorders
Fatigue
|
5.0%
2/40 • Number of events 2 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
5.0%
2/40 • Number of events 2 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
General disorders
Pain
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
General disorders
Influenza like illness
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Colitis microscopic
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Investigations
Platelet count increased
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
General disorders
Oedema peripheral
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
5.0%
2/40 • Number of events 2 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
General disorders
Inflammation
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
COVID-19
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Eye disorders
Glaucoma
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
5.0%
2/40 • Number of events 2 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/40 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.5%
1/40 • Number of events 1 • From first dose of study drug through week 12
Safety Population included all participants who received at least 1 dose of any study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After the multicenter publication or 12 months after completion of the study, whichever occurs first, Institution may publish the results of its study data. Institution and PI shall provide sponsor with an advance copy of any proposed communications at least 60 days prior and Sponsor shall have 60 days to review. Sponsor may request (a) the deletion of any Confidential Information, (b) reasonable changes, or (c) a delay for an additional period, not to exceed 90 days.
- Publication restrictions are in place
Restriction type: OTHER