The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors 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 1:1:1:1 to Obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination, obicetrapib 10 mg, ezetimibe 10 mg or placebo for a 84 day treatment period. After the treatment period, patients will have an end of study follow-up visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
407
tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
tablet; 10mg obicetrapib
capsule; 10mg ezetimibe
tablet; no active ingredient
tablet; no active ingredient
capsule; no active ingredient
East Valley Diabetes & Endocrinology
Gilbert, Arizona, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Centricity Research - Columbus
Columbus, Georgia, United States
Center for Advanced Research and Education
Gainesville, Georgia, United States
Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C
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).
Time frame: 84 Days
Effect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C
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).
Time frame: 84 Days
Effect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C
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).
Time frame: 84 Days
Effect of Obicetrapib Monotherapy Compared to Placebo on LDL-C
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).
Time frame: 84 Days
Effect of Fixed Dose Combination (FDC) Compared to Placebo on Non-HDL-C
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.
Time frame: 84 Days
Effect of Fixed Dose Combination (FDC) Compared to Placebo on Apolipoprotein B (ApoB)
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.
Time frame: 84 Days
Effect of Obicetrapib Monotherapy Compared to Placebo on Non-HDL-C
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.
Time frame: 84 Days
Effect of Obicetrapib Monotherapy Compared to Placebo on Apolipoprotein B (ApoB)
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.
Time frame: 84 Days
Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Non-HDL-C
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.
Time frame: 84 Days
Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Apolipoprotein B (ApoB)
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.
Time frame: 84 Days
Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Non-HDL-C
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.
Time frame: 84 Days
Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Apolipoprotein B (ApoB)
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.
Time frame: 84 Days
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