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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05202509

Acronym

PREVAIL

Enrollment

9541

Registered

2022-01-21

Start date

2022-02-07

Completion date

2026-11-30

Last updated

2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic Cardiovascular Disease

Brief summary

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

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

Interventions

DRUGObicetrapib

10mg obicetrapib tablet

DRUGPlacebo

Placebo tablet to resemble obicetrapib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Matching placebo to active

Intervention model description

Placebo-Controlled, Double-Blind, Randomized

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Major Adverse Cardiovascular Effect (MACE)	30 months after last participant randomized	To evaluate the effect of obicetrapib on the risk of MACE

Countries

Australia, Bulgaria, Canada, China, Croatia, Czechia, Denmark, Finland, Georgia, Germany, Hungary, Israel, Italy, Japan, Jordan, Latvia, Netherlands, Poland, Slovakia, South Africa, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026