Trial Outcomes & Findings for Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies (NCT NCT06005597)
NCT ID: NCT06005597
Last Updated: 2025-10-08
Results Overview
LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
407 participants
Primary outcome timeframe
84 Days
Results posted on
2025-10-08
Participant Flow
716 participants were screened: out of 716, 407 participants were randomized (1:1:1:1) (FDC therapy: Obicetrapib monotherapy: Ezetimibe monotherapy: placebo)
Participant milestones
| Measure |
Fixed Dose Combination
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Monotherapy Obicetrapib
once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
Monotherapy obicetrapib: tablet; 10mg obicetrapib
Combination Therapy placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Monotherapy Ezetimibe
once-daily ezetimibe 10 mg capsule, 2 placebo tablets
Monotherapy ezetimibe: capsule; 10mg ezetimibe
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
|
Placebo
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
102
|
102
|
101
|
102
|
|
Overall Study
COMPLETED
|
100
|
99
|
99
|
100
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
2
|
2
|
Reasons for withdrawal
| Measure |
Fixed Dose Combination
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Monotherapy Obicetrapib
once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
Monotherapy obicetrapib: tablet; 10mg obicetrapib
Combination Therapy placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Monotherapy Ezetimibe
once-daily ezetimibe 10 mg capsule, 2 placebo tablets
Monotherapy ezetimibe: capsule; 10mg ezetimibe
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
|
Placebo
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
2
|
|
Overall Study
Death
|
1
|
1
|
1
|
0
|
Baseline Characteristics
Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
Baseline characteristics by cohort
| Measure |
Fixed Dose Combination
n=102 Participants
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Monotherapy Obicetrapib
n=102 Participants
once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
Monotherapy obicetrapib: tablet; 10mg obicetrapib
Combination Therapy placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Monotherapy Ezetimibe
n=101 Participants
once-daily ezetimibe 10 mg capsule, 2 placebo tablets
Monotherapy ezetimibe: capsule; 10mg ezetimibe
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
|
Placebo
n=102 Participants
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Total
n=407 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 9.43 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 9.64 • n=7 Participants
|
67.6 years
STANDARD_DEVIATION 8.71 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 9.47 • n=4 Participants
|
66.9 years
STANDARD_DEVIATION 9.30 • n=21 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
177 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
230 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
98 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
398 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
337 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Baseline Low-Density Lipoprotein Cholesterol (LDL-C)
|
96.5 mg/dL
STANDARD_DEVIATION 28.80 • n=5 Participants
|
100.0 mg/dL
STANDARD_DEVIATION 35.34 • n=7 Participants
|
98.2 mg/dL
STANDARD_DEVIATION 31.09 • n=5 Participants
|
91.0 mg/dL
STANDARD_DEVIATION 25.81 • n=4 Participants
|
96.4 mg/dL
STANDARD_DEVIATION 30.26 • n=21 Participants
|
PRIMARY outcome
Timeframe: 84 DaysPopulation: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Outcome measures
| Measure |
Fixed Dose Combination
n=102 Participants
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Placebo
n=100 Participants
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
|---|---|---|
|
Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C
|
-45.58 percent change from baseline
Standard Error 3.465
|
3.03 percent change from baseline
Standard Error 3.564
|
PRIMARY outcome
Timeframe: 84 DaysPopulation: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Outcome measures
| Measure |
Fixed Dose Combination
n=102 Participants
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Placebo
n=101 Participants
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
|---|---|---|
|
Effect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C
|
-45.58 percent change from baseline
Standard Error 3.465
|
-17.63 percent change from baseline
Standard Error 3.497
|
PRIMARY outcome
Timeframe: 84 DaysPopulation: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10 mg group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Outcome measures
| Measure |
Fixed Dose Combination
n=102 Participants
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Placebo
n=102 Participants
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
|---|---|---|
|
Effect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C
|
-45.58 percent change from baseline
Standard Error 3.465
|
-28.82 percent change from baseline
Standard Error 3.484
|
PRIMARY outcome
Timeframe: 84 DaysPopulation: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Outcome measures
| Measure |
Fixed Dose Combination
n=102 Participants
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Placebo
n=100 Participants
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
|---|---|---|
|
Effect of Obicetrapib Monotherapy Compared to Placebo on LDL-C
|
-28.82 percent change from baseline
Standard Error 3.484
|
3.03 percent change from baseline
Standard Error 3.564
|
SECONDARY outcome
Timeframe: 84 DaysPopulation: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group.
Outcome measures
| Measure |
Fixed Dose Combination
n=102 Participants
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Placebo
n=102 Participants
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
|---|---|---|
|
Effect of Fixed Dose Combination (FDC) Compared to Placebo on Non-HDL-C
|
-42.42 percent change from baseline
Standard Error 2.977
|
2.71 percent change from baseline
Standard Error 3.017
|
SECONDARY outcome
Timeframe: 84 DaysPopulation: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group.
Outcome measures
| Measure |
Fixed Dose Combination
n=102 Participants
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Placebo
n=102 Participants
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
|---|---|---|
|
Effect of Fixed Dose Combination (FDC) Compared to Placebo on Apolipoprotein B (ApoB)
|
-26.91 percent change from baseline
Standard Error 2.425
|
2.28 percent change from baseline
Standard Error 2.466
|
SECONDARY outcome
Timeframe: 84 DaysPopulation: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib monotherapy 10 mg group compared to the placebo group.
Outcome measures
| Measure |
Fixed Dose Combination
n=102 Participants
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Placebo
n=102 Participants
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
|---|---|---|
|
Effect of Obicetrapib Monotherapy Compared to Placebo on Non-HDL-C
|
-27.19 percent change from baseline
Standard Error 3.010
|
2.71 percent change from baseline
Standard Error 3.017
|
SECONDARY outcome
Timeframe: 84 DaysPopulation: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib monotherapy 10 mg group compared to the placebo group.
Outcome measures
| Measure |
Fixed Dose Combination
n=102 Participants
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Placebo
n=102 Participants
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
|---|---|---|
|
Effect of Obicetrapib Monotherapy Compared to Placebo on Apolipoprotein B (ApoB)
|
-17.50 percent change from baseline
Standard Error 2.482
|
2.28 percent change from baseline
Standard Error 2.466
|
SECONDARY outcome
Timeframe: 84 DaysPopulation: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group.
Outcome measures
| Measure |
Fixed Dose Combination
n=102 Participants
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Placebo
n=101 Participants
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
|---|---|---|
|
Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Non-HDL-C
|
-42.42 percent change from baseline
Standard Error 2.977
|
-16.98 percent change from baseline
Standard Error 3.006
|
SECONDARY outcome
Timeframe: 84 DaysPopulation: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group.
Outcome measures
| Measure |
Fixed Dose Combination
n=102 Participants
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Placebo
n=101 Participants
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
|---|---|---|
|
Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Apolipoprotein B (ApoB)
|
-26.91 percent change from baseline
Standard Error 2.425
|
-12.71 percent change from baseline
Standard Error 2.495
|
SECONDARY outcome
Timeframe: 84 DaysPopulation: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10mg group.
Outcome measures
| Measure |
Fixed Dose Combination
n=102 Participants
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Placebo
n=102 Participants
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
|---|---|---|
|
Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Non-HDL-C
|
-42.42 percent change from baseline
Standard Error 2.977
|
-27.19 percent change from baseline
Standard Error 3.010
|
SECONDARY outcome
Timeframe: 84 DaysPopulation: Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group.
LS mean percent change in Apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10 mg group.
Outcome measures
| Measure |
Fixed Dose Combination
n=102 Participants
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Placebo
n=102 Participants
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
|---|---|---|
|
Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Apolipoprotein B (ApoB)
|
-26.91 percent change from baseline
Standard Error 2.425
|
-17.50 percent change from baseline
Standard Error 2.482
|
Adverse Events
Fixed Dose Combination
Serious events: 3 serious events
Other events: 30 other events
Deaths: 1 deaths
Monotherapy Obicetrapib
Serious events: 6 serious events
Other events: 62 other events
Deaths: 1 deaths
Monotherapy Ezetimibe
Serious events: 7 serious events
Other events: 35 other events
Deaths: 1 deaths
Placebo
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fixed Dose Combination
n=102 participants at risk
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Monotherapy Obicetrapib
n=102 participants at risk
once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
Monotherapy obicetrapib: tablet; 10mg obicetrapib
Combination Therapy placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Monotherapy Ezetimibe
n=101 participants at risk
once-daily ezetimibe 10 mg capsule, 2 placebo tablets
Monotherapy ezetimibe: capsule; 10mg ezetimibe
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
|
Placebo
n=102 participants at risk
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.99%
1/101 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.99%
1/101 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.99%
1/101 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.99%
1/101 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.99%
1/101 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.99%
1/101 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.98%
1/102 • Number of events 2 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.99%
1/101 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.99%
1/101 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.0%
2/101 • Number of events 2 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.99%
1/101 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.99%
1/101 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Vascular disorders
Arterial haemorrhage
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Vascular disorders
Shock
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
General disorders
Chest pain
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
Other adverse events
| Measure |
Fixed Dose Combination
n=102 participants at risk
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Fixed Dose Combination: tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Monotherapy Obicetrapib
n=102 participants at risk
once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
Monotherapy obicetrapib: tablet; 10mg obicetrapib
Combination Therapy placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
Monotherapy Ezetimibe
n=101 participants at risk
once-daily ezetimibe 10 mg capsule, 2 placebo tablets
Monotherapy ezetimibe: capsule; 10mg ezetimibe
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
|
Placebo
n=102 participants at risk
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo: tablet; no active ingredient
Obicetrapib Placebo: tablet; no active ingredient
Ezetimibe Placebo: capsule; no active ingredient
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
4/102 • Number of events 4 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
3.9%
4/102 • Number of events 4 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
3.0%
3/101 • Number of events 3 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.9%
3/102 • Number of events 3 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
COVID-19
|
3.9%
4/102 • Number of events 4 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.99%
1/101 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
Bronchitis
|
2.0%
2/102 • Number of events 2 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
3.9%
4/102 • Number of events 4 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
Cellulitis
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.9%
3/102 • Number of events 3 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.0%
2/102 • Number of events 3 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.0%
2/102 • Number of events 2 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
3.0%
3/101 • Number of events 3 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
2/102 • Number of events 2 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
6.9%
7/102 • Number of events 8 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
5.0%
5/101 • Number of events 6 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.9%
3/102 • Number of events 3 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.0%
2/102 • Number of events 2 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
3.0%
3/101 • Number of events 3 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
2/102 • Number of events 2 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.9%
3/102 • Number of events 3 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
4.0%
4/101 • Number of events 4 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
5/102 • Number of events 6 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.9%
3/102 • Number of events 3 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.0%
2/101 • Number of events 2 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
4.9%
5/102 • Number of events 5 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.99%
1/101 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Investigations
C-reactive protein increased
|
2.0%
2/102 • Number of events 2 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.99%
1/101 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.9%
3/102 • Number of events 3 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.0%
2/102 • Number of events 2 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
3.0%
3/101 • Number of events 3 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Nervous system disorders
Headache
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
5.9%
6/102 • Number of events 6 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.99%
1/101 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.0%
2/102 • Number of events 2 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Vascular disorders
Hypertension
|
3.9%
4/102 • Number of events 5 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
8.8%
9/102 • Number of events 10 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.0%
2/101 • Number of events 2 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.9%
3/102 • Number of events 3 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
General disorders
Fatigue
|
3.9%
4/102 • Number of events 4 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
4.9%
5/102 • Number of events 6 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
3.0%
3/101 • Number of events 3 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.98%
1/102 • Number of events 1 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
3.0%
3/101 • Number of events 4 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/102 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
3.9%
4/102 • Number of events 4 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/101 • From first dose of study drug up to Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/102 • From first dose of study drug up to Week 16
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