Dyslipidemias, High Cholesterol, Hypercholesterolemia, Familial Hypercholesterolemia, Lipid Metabolism Disorder, Metabolic Disease, Lipid Metabolism, Inborn Errors, Genetic Disease, Inborn, Hyperlipoproteinemias
Conditions
Keywords
Obicetrapib, BROOKLYN, Cholesteryl ester transfer protein (CETP) inhibitor, Heterozygous Familial Hypercholesterolemia (HeFH), LDL-C
Brief summary
This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH).
Detailed description
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with HeFH to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy. The screening period for this study will take up to 14 days. Afterwards, patients will be randomized to placebo or 10 mg obicetrapib for an 365-day treatment period. After the treatment period, participants will have an end-of-study follow-up visit.
Interventions
DRUGObicetrapib
10 mg Obicetrapib tablet
DRUGPlacebo
placebo tablet made to resemble active
Sponsors
NewAmsterdam Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
placebo tablet made to resemble active
Intervention model description
Placebo-Controlled, double-blind, randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a history of heterozygous familial hypercholesterolemia (HeFH) by 1) Genotyping (not a screening assessment), WHO Criteria/Dutch Lipid Clinical Network Criteria with a score of \> 8 points; and/or Simon Broome Register Diagnostic Criteria for definite or possible Familial Hypercholesterolemia (FH) * Maximally tolerated lipid Modifying therapy for at least 8 weeks prior to screening such as: ATV (40 or 80), or (ROS 20 or 40 mg), Ezetimide, Bempedoic Acid, PCSK9 targeted therapy for at least 4 doses * Fasting serum LDL-C ≥70 mg/dL (≥1.80 mmol/L)
Exclusion criteria
* New York Heart Association class II or IV heart failure or last known left ventricular ejection fraction \< 30%; * Hospitalized for heart failure within 5 years prior to Screening * Major adverse cardiac event (MACE) within 3 months prior to Screening; * HbA1c ≥10%, or fasting glucose * Formal diagnosis of homozygous familial hypercholesterolemia (HoFH) * Uncontrolled severe hypertension, defined as either systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg prior to Randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC] | 84 Days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Total Cholesterol From Baseline to Day 84 | 84 Days | LS mean percent change from baseline to Day 84 in Total Cholesterol (TC) in obicetrapib group compared to the placebo group |
| Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins] | 180 Days | 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). |
| Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC] | 365 Days | 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). |
| Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84 | 84 Days | LS mean percent change from baseline to Day 84 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group. |
| Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180 | 180 Days | LS mean percent change from baseline to Day 180 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group |
| Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365 | 365 Days | LS mean percent change from baseline to Day 365 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group |
| Percent Change in Non-HDL-C From Baseline to Day 84 | 84 Days | 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 |
| Percent Change in Non-HDL-C From Baseline to Day 180 | 180 Days | 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 |
| Percent Change in Non-HDL-C From Baseline to Day 365 | 365 Days | 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 |
| Percent Change in Lp(a) From Baseline to Day 365 | 365 Days | LS mean percent change from baseline to Day 365 in Lipoprotein (a) \[Lp(a)\] in obicetrapib group compared to the placebo group |
| Percent Change in HDL-C From Baseline to Day 180 | 180 Days | LS mean percent change from baseline to Day 180 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group |
| Percent Change in HDL-C From Baseline to Day 365 | 365 Days | LS mean percent change from baseline to Day 365 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group |
| Percent Change in Lp(a) From Baseline to Day 84 | 84 Days | LS mean percent change from baseline to Day 84 in Lipoprotein (a) \[Lp(a)\] in obicetrapib group compared to the placebo group |
| Percent Change in Total Cholesterol From Baseline to Day 180 | 180 Days | LS mean percent change from baseline to Day 180 in Total Cholesterol in obicetrapib group compared to the placebo group |
| Percent Change in Total Cholesterol From Baseline to Day 365 | 365 Days | LS mean percent change from baseline to Day 365 in Total Cholesterol in obicetrapib group compared to the placebo group |
| Percent Change in Triglycerides From Baseline to Day 84 | 84 Days | LS mean percent change from baseline to Day 84 in Triglycerides in obicetrapib group compared to the placebo group |
| Percent Change in Triglycerides From Baseline to Day 180 | 180 Days | LS mean percent change from baseline to Day 180 in Triglycerides in obicetrapib group compared to the placebo group |
| Precent Change in Triglycerides From Baseline to Day 365 | 365 days | LS mean percent change from baseline to Day 365 in Triglycerides in obicetrapib group compared to the placebo group |
| Percent Change in HDL-C From Baseline to Day 84 | 84 Days | LS mean percent change from baseline to Day 84 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group |
Countries
Canada, Czechia, Georgia, Netherlands, Norway, Poland, South Africa, Spain, United Kingdom, United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Placebo one placebo tablet once daily
Placebo: placebo tablet made to resemble active | 118 |
| Obicetrapib 10 mg one 10 mg Obicetrapib tablet once daily
Obicetrapib: 10 mg Obicetrapib tablet | 236 |
| Total | 354 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Death | 2 | 3 |
| 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 | Lost to Follow-up | 1 | 2 |
| Overall Study | Subject decision | 1 | 0 |
| Overall Study | Withdrawal of Consent | 3 | 3 |
Baseline characteristics
| Characteristic | Placebo | Obicetrapib 10 mg | Total |
|---|---|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 11.06 | 57 years STANDARD_DEVIATION 12.7 | 56.9 years STANDARD_DEVIATION 12.16 |
| Baseline Low-Density Lipoprotein Cholesterol (LDL-C) | 119.9 mg/dL STANDARD_DEVIATION 54.47 | 123.4 mg/dL STANDARD_DEVIATION 49.23 | 121.65 mg/dL STANDARD_DEVIATION 51.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 8 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 114 Participants | 226 Participants | 340 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) White | 110 Participants | 219 Participants | 329 Participants |
| Sex: Female, Male Female | 65 Participants | 125 Participants | 190 Participants |
| Sex: Female, Male Male | 53 Participants | 111 Participants | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 118 | 3 / 234 |
| other Total, other adverse events | 52 / 118 | 95 / 234 |
| serious Total, serious adverse events | 8 / 118 | 13 / 234 |
Outcome results
Primary
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC]
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).
Time frame: 84 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC] | .25 percent change from baseline | Standard Error 2.48 |
| Obicetrapib 10 mg | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC] | -36.05 percent change from baseline | Standard Error 1.769 |
p-value: <0.000195% CI: [-42.22, -30.39]ANCOVA
Secondary
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180
LS mean percent change from baseline to Day 180 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group
Time frame: 180 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180 | 6.02 percent change from baseline | Standard Error 2.127 |
| Obicetrapib 10 mg | Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180 | -18.30 percent change from baseline | Standard Error 1.472 |
p-value: <0.000195% CI: [-29.38, -19.25]ANCOVA
Secondary
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365
LS mean percent change from baseline to Day 365 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group
Time frame: 365 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365 | 8.15 percent change from baseline | Standard Error 2.633 |
| Obicetrapib 10 mg | Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365 | -17.62 percent change from baseline | Standard Error 1.663 |
p-value: <0.000195% CI: [-31.88, -19.67]ANCOVA
Secondary
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84
LS mean percent change from baseline to Day 84 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.
Time frame: 84 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84 | 2.93 percent change from baseline | Standard Error 1.758 |
| Obicetrapib 10 mg | Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84 | -21.45 percent change from baseline | Standard Error 1.219 |
p-value: <0.000195% CI: [-28.58, -20.2]ANCOVA
Secondary
Percent Change in HDL-C From Baseline to 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
Time frame: 180 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in HDL-C From Baseline to Day 180 | 2.63 percent change from baseline | Standard Error 5.484 |
| Obicetrapib 10 mg | Percent Change in HDL-C From Baseline to Day 180 | 133.83 percent change from baseline | Standard Error 3.73 |
p-value: <0.000195% CI: [118.27, 144.13]ANCOVA
Secondary
Percent Change in HDL-C From Baseline to 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
Time frame: 365 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in HDL-C From Baseline to Day 365 | 6.28 percent change from baseline | Standard Error 5.994 |
| Obicetrapib 10 mg | Percent Change in HDL-C From Baseline to Day 365 | 127.67 percent change from baseline | Standard Error 4.222 |
p-value: <0.000195% CI: [107.02, 135.76]ANCOVA
Secondary
Percent Change in HDL-C From Baseline to 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
Time frame: 84 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in HDL-C From Baseline to Day 84 | 1.26 percent change from baseline | Standard Error 5.078 |
| Obicetrapib 10 mg | Percent Change in HDL-C From Baseline to Day 84 | 139.92 percent change from baseline | Standard Error 3.614 |
p-value: <0.000195% CI: [126.42, 150.9]ANCOVA
Secondary
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins]
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).
Time frame: 180 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| Obicetrapib 10 mg | Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins] | -31.80 percent change from baseline | Standard Error 2.054 |
p-value: <0.000195% CI: [-44.79, -30.78]ANCOVA
Secondary
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC]
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).
Time frame: 365 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| Obicetrapib 10 mg | Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC] | -31.14 percent change from baseline | Standard Error 2.544 |
p-value: <0.000195% CI: [-51.14, -31.76]ANCOVA
Secondary
Percent Change in Lp(a) From Baseline to Day 365
LS mean percent change from baseline to Day 365 in Lipoprotein (a) \[Lp(a)\] in obicetrapib group compared to the placebo group
Time frame: 365 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Lp(a) From Baseline to Day 365 | 24.37 percent change from baseline | Standard Error 37.111 |
| Obicetrapib 10 mg | Percent Change in Lp(a) From Baseline to Day 365 | -29.93 percent change from baseline | Standard Error 11.224 |
p-value: 0.164895% CI: [-131.13, 22.53]ANCOVA
Secondary
Percent Change in Lp(a) From Baseline to Day 84
LS mean percent change from baseline to Day 84 in Lipoprotein (a) \[Lp(a)\] in obicetrapib group compared to the placebo group
Time frame: 84 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Lp(a) From Baseline to Day 84 | 10.52 percent change from baseline | Standard Error 9.413 |
| Obicetrapib 10 mg | Percent Change in Lp(a) From Baseline to Day 84 | -35.42 percent change from baseline | Standard Error 4.527 |
p-value: <0.000195% CI: [-65.88, -26]ANCOVA
Secondary
Percent Change in Non-HDL-C From Baseline to 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
Time frame: 180 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Non-HDL-C From Baseline to Day 180 | 5.92 percent change from baseline | Standard Error 2.658 |
| Obicetrapib 10 mg | Percent Change in Non-HDL-C From Baseline to Day 180 | -27.08 percent change from baseline | Standard Error 1.855 |
p-value: <0.000195% CI: [-39.36, -26.65]ANCOVA
Secondary
Percent Change in Non-HDL-C From Baseline to 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
Time frame: 365 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Non-HDL-C From Baseline to Day 365 | 11.64 percent change from baseline | Standard Error 3.905 |
| Obicetrapib 10 mg | Percent Change in Non-HDL-C From Baseline to Day 365 | -25.84 percent change from baseline | Standard Error 2.305 |
p-value: <0.000195% CI: [-46.38, -28.58]ANCOVA
Secondary
Percent Change in Non-HDL-C From Baseline to 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
Time frame: 84 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Non-HDL-C From Baseline to Day 84 | 2.83 percent change from baseline | Standard Error 2.188 |
| Obicetrapib 10 mg | Percent Change in Non-HDL-C From Baseline to Day 84 | -31.62 percent change from baseline | Standard Error 1.52 |
p-value: <0.000195% CI: [-39.67, -29.24]ANCOVA
Secondary
Percent Change in Total Cholesterol From Baseline to Day 180
LS mean percent change from baseline to Day 180 in Total Cholesterol in obicetrapib group compared to the placebo group
Time frame: 180 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Total Cholesterol From Baseline to Day 180 | 4.44 percent change from baseline | Standard Error 2.043 |
| Obicetrapib 10 mg | Percent Change in Total Cholesterol From Baseline to Day 180 | 14.43 percent change from baseline | Standard Error 1.438 |
Secondary
Percent Change in Total Cholesterol From Baseline to Day 365
LS mean percent change from baseline to Day 365 in Total Cholesterol in obicetrapib group compared to the placebo group
Time frame: 365 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Total Cholesterol From Baseline to Day 365 | 9.32 percent change from baseline | Standard Error 2.801 |
| Obicetrapib 10 mg | Percent Change in Total Cholesterol From Baseline to Day 365 | 13.92 percent change from baseline | Standard Error 1.684 |
Secondary
Percent Change in Total Cholesterol From Baseline to Day 84
LS mean percent change from baseline to Day 84 in Total Cholesterol (TC) in obicetrapib group compared to the placebo group
Time frame: 84 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Total Cholesterol From Baseline to Day 84 | 2.34 percent change from baseline | Standard Error 1.796 |
| Obicetrapib 10 mg | Percent Change in Total Cholesterol From Baseline to Day 84 | 12.09 percent change from baseline | Standard Error 1.268 |
Secondary
Percent Change in Triglycerides From Baseline to Day 180
LS mean percent change from baseline to Day 180 in Triglycerides in obicetrapib group compared to the placebo group
Time frame: 180 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Triglycerides From Baseline to Day 180 | 12.43 percent change from baseline | Standard Error 4.178 |
| Obicetrapib 10 mg | Percent Change in Triglycerides From Baseline to Day 180 | 4.49 percent change from baseline | Standard Error 2.885 |
Secondary
Percent Change in Triglycerides From Baseline to Day 84
LS mean percent change from baseline to Day 84 in Triglycerides in obicetrapib group compared to the placebo group
Time frame: 84 Days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Triglycerides From Baseline to Day 84 | 10.16 percent change from baseline | Standard Error 4.207 |
| Obicetrapib 10 mg | Percent Change in Triglycerides From Baseline to Day 84 | -1.57 percent change from baseline | Standard Error 2.58 |
Secondary
Precent Change in Triglycerides From Baseline to Day 365
LS mean percent change from baseline to Day 365 in Triglycerides in obicetrapib group compared to the placebo group
Time frame: 365 days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Precent Change in Triglycerides From Baseline to Day 365 | 7.39 percent change from baseline | Standard Error 5.642 |
| Obicetrapib 10 mg | Precent Change in Triglycerides From Baseline to Day 365 | 2.27 percent change from baseline | Standard Error 3.219 |