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

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.

Eligibility

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 ≥ 70 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

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