NCT05202509

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9,541 (actual)
• Sponsor: NewAmsterdam Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Atherosclerotic Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Obicetrapib	10mg obicetrapib tablet
DRUG	Placebo	Placebo tablet to resemble obicetrapib

Timeline

• Start date: 2022-02-07
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2022-01-21
• Last updated: 2024-06-04

Locations

591 sites across 23 countries: United States, Australia, Bulgaria, Canada, China, Croatia, Czechia, Denmark, Finland, Georgia, Germany, Hungary, Israel, Italy, Japan, Jordan, Latvia, Netherlands, Poland, Slovakia, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study