Overview
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.
Description
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
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 ≥ 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
