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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Placebo Controlled, Double Blind, Randomized Cardiovascular Outcome Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With ASCVD Not Adequately Controlled Despite Maximally Tolerated Lipid Modifying Therapies

Conditions
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Atherosclerotic Cardiovascular Disease

Intervention / Treatment
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* Drug: Obicetrapib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Placebo-Controlled, Double-Blind, Randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: obicetrapib 10mg<br>one 10mg tablet, once daily. | Drug: Obicetrapib<br>* 10mg obicetrapib tablet<br>|
| Placebo Comparator: Placebo<br>one placebo tablet, once daily | Drug: Placebo<br>* Placebo tablet to resemble obicetrapib<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Effect (MACE) | To evaluate the effect of obicetrapib on the risk of MACE | 32 months after last participant randomized |