Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy.

This study will be a placebo-controlled, double-blind, randomized, phase 3 study to evaluate the effect of 10mg Obicetrapib in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy to reduce the risk of cardiovascular death, myocardial infarction, stroke and non-elective coronary revascularization. The PREVAIL Study

Inclusion Criteria: * Males \& females ≥ 18 years age. * Established ASCVD including: * Coronary artery disease * Cerebrovascular disease * Peripheral Artery disease * On maximally tolerated lipid-modifying therapy * Fasting LDL-C ≥ 55 mg/dL * Fasting triglycerides \< 400 mg/dL * Estimated glomerular filtration rate ≥ 30 mL/min Exclusion Criteria: * New York Heart Association class III or IV heart failure or left ventricular ejection fraction \< 30% * Have been hospitalized for Heart Failure within 5 years prior to screening * Had non-fatal MI, non-fatal stroke, non-elective coronary revascularization and/or hospitalization for unstable angina or chest pain within past 3 months prior to screening * Uncontrolled hypertension * Diagnosis of homozygous familial hypercholesterolemia (HoFH) * Active liver disease * HbA1c ≥10% * Thyroid Stimulating Hormone (TSH) \> 1.5 times upper limit normal * Creatine kinase \> 3 times upper limit normal * History of malignancy with surgery in past 3 years * History of alcohol or drug abuse within past 5 years * Received treatment with investigational product or device within past 30 days excluding Coronavirus treatment or vaccine * Known allergy to study drug * Participated in previous obicetrapib trial * Taking gemfibrozil within 30 days screening