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Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

NCT05202509•NewAmsterdam Pharma

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

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
+5 more criteria

Locations (591)

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

Muscle Shoals, Alabama, United States

Syed Research Consultants

Sheffield, Alabama, United States

Elite Clinical Studies

Phoenix, Arizona, United States

Key Dates

Start Date

February 7, 2022

Primary Completion Date

November 1, 2026

Completion Date

November 1, 2026

Last Updated

June 4, 2024

Enrollment

9,541

ACTUAL participants

Conditions

Atherosclerotic Cardiovascular Disease

Interventions

Obicetrapib

DRUG

Placebo

DRUG

Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD

NCT06813911

Atherosclerotic Cardiovascular Disease (ASCVD)

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RECRUITING

A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease

NCT06295679

Major Cardiovascular EventEstablished Atherosclerotic Cardiovascular Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD

A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease

A Pragmatic INitiative for LDL-C Management by a CLinical Pharmacist-Led Team Among Atherosclerotic CardiovascUlar DisEase Patients

Coated or Chewable Aspirin and a Hybrid Strategy to Mitigate Adverse Effects of Air Pollution in Stable Atherosclerotic Disease

Effect of Ezetimibe on Gut Microbiota

A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.