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

Phase 3

Active, not recruiting

• Conditions: Atherosclerotic Cardiovascular Disease
• Interventions: Drug: Placebo; Drug: Obicetrapib

• Registration Number: NCT05202509
• Lead Sponsor: NewAmsterdam Pharma

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

Study Timeline

• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-01-21
• Study Start: 2022-02-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 9541

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	one placebo tablet, once daily
obicetrapib 10mg	Obicetrapib	one 10mg tablet, once daily.

Primary Outcome Measures

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

Trial Locations

Locations (589)

Advanced Cardiovascular LLC; 🇺🇸 Alexander City, Alabama, United States

Ascension - Cardiology Specialists of Birmingham; 🇺🇸 Birmingham, Alabama, United States

Central Alabama Research; 🇺🇸 Birmingham, Alabama, United States

Cardiovascular Associates of the Southeast, LLC; 🇺🇸 Birmingham, Alabama, United States

Eastern Shore Research Institute, LLC; 🇺🇸 Fairhope, Alabama, United States

The Heart Center Research; 🇺🇸 Huntsville, Alabama, United States

Mobile Heart Specialists; 🇺🇸 Mobile, Alabama, United States

Syed Research Consultants; 🇺🇸 Sheffield, Alabama, United States

Elite Clinical Studies; 🇺🇸 Phoenix, Arizona, United States

Clinical Research Institute of Arizona, LLC; 🇺🇸 Sun City West, Arizona, United States

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