Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

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.

Inclusion criteria

• Have underlying HeFH and/or a history of ASCVD or multiple ASCVD risk factors
• On maximally tolerated lipid-modifying therapy as an adjunct to a diet and lifestyle modifications
• LDL-C ≥ 70 mg/dL
• Triglycerides < 500
• Estimated glomerular filtration rate ≥ 15 mL/min/1.73 m2

Exclusion criteria

• History of New York Heart Association (NYHA) class III or IV heart failure of left ventricular ejection fraction <30%
• Hospitalized for heart failure within the last 5 years
• Myocardial infarction, stroke, non-elective coronary revascularization or hospitalization for unstable angina or chest pain in the last 3 months
• Uncontrolled severe hypertension
• Diagnosis of homozygous FH
• Liver disease
• HbA1c ≥ 10.0% or fasting glucose ≥ 270 mg/dL
• Thyroid-stimulating hormone >1.5 x upper limit of normal (ULN)
• History of malignancy
• Creatinine kinase (CK) >3 X ULN
• Alcohol abuse
• Treatment with investigational product
• Treatment with gemfibrozil or ezetimibe
• Previous participation in a trial evaluating obicetrapib
• Known allergy to study drugs, placebo or excipients in study drugs of placebo
• Other condition that would interfere with the conduct of the study