Trial Outcomes & Findings for Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies. (NCT NCT05425745)
NCT ID: NCT05425745
Last Updated: 2025-06-11
Results Overview
LS mean percent change from baseline to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group \[PUC\]. LDL-C level was measured by preparative ultracentrifugation (PUC).
COMPLETED
PHASE3
354 participants
84 Days
2025-06-11
Participant Flow
513 patients were screened: out of 513, 354 participants were randomized: 236 participants to the obicetrapib 10 mg group and 118 participants to the placebo group
Participant milestones
| Measure |
Placebo
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Overall Study
STARTED
|
118
|
236
|
|
Overall Study
COMPLETED
|
110
|
226
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
| Measure |
Placebo
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Overall Study
Withdrawal of Consent
|
3
|
3
|
|
Overall Study
Death
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Did not return for end of study visit
|
0
|
1
|
|
Overall Study
End of study visit completed by phone
|
1
|
0
|
|
Overall Study
Subject decision
|
1
|
0
|
Baseline Characteristics
4 participants were missing baseline LDL-C (measured by PUC). 2 pts baseline LDL-C results were not available due to low volume or hemolysis. 2 pts were randomized but did not receive study drug. Therefore, baseline values (baseline defined as the last measurement prior to the first dose of study drug) were not available.
Baseline characteristics by cohort
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=236 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
Total
n=354 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 11.06 • n=118 Participants
|
57 years
STANDARD_DEVIATION 12.70 • n=236 Participants
|
56.9 years
STANDARD_DEVIATION 12.16 • n=354 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=118 Participants
|
125 Participants
n=236 Participants
|
190 Participants
n=354 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=118 Participants
|
111 Participants
n=236 Participants
|
164 Participants
n=354 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=118 Participants
|
8 Participants
n=236 Participants
|
10 Participants
n=354 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=118 Participants
|
226 Participants
n=236 Participants
|
340 Participants
n=354 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=118 Participants
|
2 Participants
n=236 Participants
|
4 Participants
n=354 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=118 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=354 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=118 Participants
|
6 Participants
n=236 Participants
|
7 Participants
n=354 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=118 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=354 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=118 Participants
|
3 Participants
n=236 Participants
|
6 Participants
n=354 Participants
|
|
Race (NIH/OMB)
White
|
110 Participants
n=118 Participants
|
219 Participants
n=236 Participants
|
329 Participants
n=354 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=118 Participants
|
4 Participants
n=236 Participants
|
7 Participants
n=354 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=118 Participants
|
4 Participants
n=236 Participants
|
5 Participants
n=354 Participants
|
|
Baseline Low-Density Lipoprotein Cholesterol (LDL-C)
|
119.9 mg/dL
STANDARD_DEVIATION 54.47 • n=118 Participants • 4 participants were missing baseline LDL-C (measured by PUC). 2 pts baseline LDL-C results were not available due to low volume or hemolysis. 2 pts were randomized but did not receive study drug. Therefore, baseline values (baseline defined as the last measurement prior to the first dose of study drug) were not available.
|
123.4 mg/dL
STANDARD_DEVIATION 49.23 • n=232 Participants • 4 participants were missing baseline LDL-C (measured by PUC). 2 pts baseline LDL-C results were not available due to low volume or hemolysis. 2 pts were randomized but did not receive study drug. Therefore, baseline values (baseline defined as the last measurement prior to the first dose of study drug) were not available.
|
121.65 mg/dL
STANDARD_DEVIATION 51.85 • n=350 Participants • 4 participants were missing baseline LDL-C (measured by PUC). 2 pts baseline LDL-C results were not available due to low volume or hemolysis. 2 pts were randomized but did not receive study drug. Therefore, baseline values (baseline defined as the last measurement prior to the first dose of study drug) were not available.
|
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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84.
LS mean percent change from baseline to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group \[PUC\]. LDL-C level was measured by preparative ultracentrifugation (PUC).
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=232 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC]
|
.25 percent change from baseline
Standard Error 2.480
|
-36.05 percent change from baseline
Standard Error 1.769
|
SECONDARY outcome
Timeframe: 180 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 180.
LS mean percent change from baseline to Day 180 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group \[Martin/Hopkins\]. LDL-C value was calculated using the Martin/Hopkins equation unless TG \>= 400 mg/dL or LDL-C \<= 50 mg/dL; where, LDL-C value was measured directly by preparative ultracentrifugation (PUC).
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins]
|
5.98 percent change from baseline
Standard Error 2.925
|
-31.80 percent change from baseline
Standard Error 2.054
|
SECONDARY outcome
Timeframe: 365 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365.
LS mean percent change from baseline to Day 365 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group \[PUC\]. LDL-C level was measured by preparative ultracentrifugation (PUC).
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=232 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC]
|
10.30 percent change from baseline
Standard Error 4.222
|
-31.14 percent change from baseline
Standard Error 2.544
|
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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84.
LS mean percent change from baseline to Day 84 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84
|
2.93 percent change from baseline
Standard Error 1.758
|
-21.45 percent change from baseline
Standard Error 1.219
|
SECONDARY outcome
Timeframe: 180 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 180.
LS mean percent change from baseline to Day 180 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180
|
6.02 percent change from baseline
Standard Error 2.127
|
-18.30 percent change from baseline
Standard Error 1.472
|
SECONDARY outcome
Timeframe: 365 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365.
LS mean percent change from baseline to Day 365 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365
|
8.15 percent change from baseline
Standard Error 2.633
|
-17.62 percent change from baseline
Standard Error 1.663
|
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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84.
LS mean percent change from baseline to Day 84 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) in obicetrapib group compared to the placebo group
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in Non-HDL-C From Baseline to Day 84
|
2.83 percent change from baseline
Standard Error 2.188
|
-31.62 percent change from baseline
Standard Error 1.520
|
SECONDARY outcome
Timeframe: 180 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 180.
LS mean percent change from baseline to Day 180 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in Non-HDL-C From Baseline to Day 180
|
5.92 percent change from baseline
Standard Error 2.658
|
-27.08 percent change from baseline
Standard Error 1.855
|
SECONDARY outcome
Timeframe: 365 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365.
LS mean percent change from baseline to Day 365 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in Non-HDL-C From Baseline to Day 365
|
11.64 percent change from baseline
Standard Error 3.905
|
-25.84 percent change from baseline
Standard Error 2.305
|
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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84.
LS mean percent change from baseline to Day 84 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in HDL-C From Baseline to Day 84
|
1.26 percent change from baseline
Standard Error 5.078
|
139.92 percent change from baseline
Standard Error 3.614
|
SECONDARY outcome
Timeframe: 180 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 180.
LS mean percent change from baseline to Day 180 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in HDL-C From Baseline to Day 180
|
2.63 percent change from baseline
Standard Error 5.484
|
133.83 percent change from baseline
Standard Error 3.730
|
SECONDARY outcome
Timeframe: 365 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365.
LS mean percent change from baseline to Day 365 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in HDL-C From Baseline to Day 365
|
6.28 percent change from baseline
Standard Error 5.994
|
127.67 percent change from baseline
Standard Error 4.222
|
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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84.
LS mean percent change from baseline to Day 84 in Lipoprotein (a) \[Lp(a)\] in obicetrapib group compared to the placebo group
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in Lp(a) From Baseline to Day 84
|
10.52 percent change from baseline
Standard Error 9.413
|
-35.42 percent change from baseline
Standard Error 4.527
|
SECONDARY outcome
Timeframe: 365 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365.
LS mean percent change from baseline to Day 365 in Lipoprotein (a) \[Lp(a)\] in obicetrapib group compared to the placebo group
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in Lp(a) From Baseline to Day 365
|
24.37 percent change from baseline
Standard Error 37.111
|
-29.93 percent change from baseline
Standard Error 11.224
|
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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84.
LS mean percent change from baseline to Day 84 in Total Cholesterol (TC) in obicetrapib group compared to the placebo group
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in Total Cholesterol From Baseline to Day 84
|
2.34 percent change from baseline
Standard Error 1.796
|
12.09 percent change from baseline
Standard Error 1.268
|
SECONDARY outcome
Timeframe: 180 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 180.
LS mean percent change from baseline to Day 180 in Total Cholesterol in obicetrapib group compared to the placebo group
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in Total Cholesterol From Baseline to Day 180
|
4.44 percent change from baseline
Standard Error 2.043
|
14.43 percent change from baseline
Standard Error 1.438
|
SECONDARY outcome
Timeframe: 365 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365.
LS mean percent change from baseline to Day 365 in Total Cholesterol in obicetrapib group compared to the placebo group
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in Total Cholesterol From Baseline to Day 365
|
9.32 percent change from baseline
Standard Error 2.801
|
13.92 percent change from baseline
Standard Error 1.684
|
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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84.
LS mean percent change from baseline to Day 84 in Triglycerides in obicetrapib group compared to the placebo group
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in Triglycerides From Baseline to Day 84
|
10.16 percent change from baseline
Standard Error 4.207
|
-1.57 percent change from baseline
Standard Error 2.580
|
SECONDARY outcome
Timeframe: 180 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 180.
LS mean percent change from baseline to Day 180 in Triglycerides in obicetrapib group compared to the placebo group
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Percent Change in Triglycerides From Baseline to Day 180
|
12.43 percent change from baseline
Standard Error 4.178
|
4.49 percent change from baseline
Standard Error 2.885
|
SECONDARY outcome
Timeframe: 365 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365.
LS mean percent change from baseline to Day 365 in Triglycerides in obicetrapib group compared to the placebo group
Outcome measures
| Measure |
Placebo
n=118 Participants
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 Participants
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Precent Change in Triglycerides From Baseline to Day 365
|
7.39 percent change from baseline
Standard Error 5.642
|
2.27 percent change from baseline
Standard Error 3.219
|
Adverse Events
Placebo
Obicetrapib 10 mg
Serious adverse events
| Measure |
Placebo
n=118 participants at risk
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 participants at risk
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
General disorders
Death
|
0.85%
1/118 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/234 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.85%
1/118 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/234 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/118 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.85%
2/234 • Number of events 2 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Cardiac disorders
Angina pectoris
|
1.7%
2/118 • Number of events 2 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/234 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.85%
1/118 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/234 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.85%
1/118 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/234 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
Diabetic gangrene
|
0.85%
1/118 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/234 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.85%
1/118 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/234 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Cardiac disorders
Sudden cardiac death
|
0.85%
1/118 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/234 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.85%
1/118 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.43%
1/234 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.85%
1/118 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/234 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.85%
1/118 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.00%
0/234 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/118 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.43%
1/234 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/118 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.43%
1/234 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/118 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.43%
1/234 • Number of events 1 • From first dose of study drug up to Week 54
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%
0/118 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.85%
2/234 • Number of events 3 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/118 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.43%
1/234 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.00%
0/118 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.43%
1/234 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/118 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.43%
1/234 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/118 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.43%
1/234 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/118 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.43%
1/234 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/118 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.43%
1/234 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/118 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.43%
1/234 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/118 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.43%
1/234 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Vascular disorders
Angiopathy
|
0.00%
0/118 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.43%
1/234 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/118 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.43%
1/234 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
Other adverse events
| Measure |
Placebo
n=118 participants at risk
one placebo tablet once daily
Placebo: placebo tablet made to resemble active
|
Obicetrapib 10 mg
n=234 participants at risk
one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet
|
|---|---|---|
|
Infections and infestations
Influenza
|
5.9%
7/118 • Number of events 7 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
9.0%
21/234 • Number of events 22 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
COVID-19
|
6.8%
8/118 • Number of events 8 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
6.4%
15/234 • Number of events 16 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
5/118 • Number of events 5 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
6.4%
15/234 • Number of events 17 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
4/118 • Number of events 4 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
5.1%
12/234 • Number of events 15 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Infections and infestations
Urinary tract infection
|
4.2%
5/118 • Number of events 5 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
3.0%
7/234 • Number of events 7 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
6/118 • Number of events 6 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
3.0%
7/234 • Number of events 7 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
3/118 • Number of events 4 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
3.8%
9/234 • Number of events 9 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.85%
1/118 • Number of events 1 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
4.3%
10/234 • Number of events 10 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
4/118 • Number of events 4 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.6%
6/234 • Number of events 8 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
6.8%
8/118 • Number of events 9 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
3.8%
9/234 • Number of events 10 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
4.2%
5/118 • Number of events 6 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
1.3%
3/234 • Number of events 4 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Vascular disorders
Hypertension
|
6.8%
8/118 • Number of events 10 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
6.0%
14/234 • Number of events 14 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
General disorders
Fatigue
|
5.9%
7/118 • Number of events 7 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
0.85%
2/234 • Number of events 2 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Nervous system disorders
Headache
|
5.1%
6/118 • Number of events 8 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
3.0%
7/234 • Number of events 9 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
3/118 • Number of events 3 • From first dose of study drug up to Week 54
Safety Population included all participants who received at least 1 dose of any study drug.
|
2.1%
5/234 • Number of events 5 • From first dose of study drug up to Week 54
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