> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/cardiovascular-outcome-study-to-evaluate-the-effect-of-a24be9af-323b-4b20-8e8f-bba1227c741b > Record changed: 2026-10-13 # Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease NCT05202509 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) Participants 9,541 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) Lead sponsor NewAmsterdam Pharma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) Start date 2022-02-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) Number of sites 591 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Acronym** PREVAIL Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Short title** Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) ## Dates **Completion date** 2026-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **First posted** 2022-01-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Registry last updated** 2024-06-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Primary completion date** 2026-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Start date** 2022-02-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) ## Size and sites **Actual participants** 9,541 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Participants** 9,541 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Number of sites** 591 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Lead sponsor** NewAmsterdam Pharma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) ## Identifiers **Registry ID** NCT05202509 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **ClinicalTrials.gov ID** NCT05202509 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** Matching placebo to active **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) ## Outcomes ### Primary outcomes 1. Major Adverse Cardiovascular Effect (MACE) Timeframe: 30 months after last participant randomized To evaluate the effect of obicetrapib on the risk of MACE Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) ## Sites - Advanced Cardiovascular LLCAlexander City, United States - Ascension - Cardiology Specialists of BirminghamBirmingham, United States - Central Alabama ResearchBirmingham, United States - Cardiovascular Associates of the Southeast, LLCBirmingham, United States - Eastern Shore Research Institute, LLCFairhope, United States - The Heart Center ResearchHuntsville, United States - Mobile Heart SpecialistsMobile, United States - Syed Research ConsultantsMuscle Shoals, United States - Syed Research ConsultantsSheffield, United States - Elite Clinical StudiesPhoenix, United States - Clinical Research Institute of Arizona, LLCSun City West, United States - Eclipse Clinical ResearchTucson, United States - NEA Baptist clinicJonesboro, United States - Cardiology and Medicine ClinicLittle Rock, United States - Advanced Research CenterAnaheim, United States - Westside Medical Associates of Los AngelesBeverly Hills, United States - Hope Clinical Research LLCCanoga Park, United States - Titan Medical Research - OceansideEncinitas, United States - Clinical Trials ResearchLincoln, United States - Torrance Clinical Research Institute Inc.Lomita, United States - American Institute of ResearchLos Angeles, United States - Amicis Research Center-NorthridgeNorthridge, United States - Amicis ResearchNorthridge, United States - Valley Clinical Trials, IncNorthridge, United States - Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical CenterTorrance, United States And 566 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05202509) ## Related records ### Drugs (1) - [Obicetrapib](https://trialight.com/data/asset/obicetrapib-41ee1f14-bdc7-46e1-adcb-5f53d79c7b97.md) ### Collaborators (1) - Monash University ### Lead sponsors (1) - [NewAmsterdam Pharma](https://trialight.com/data/company/newamsterdam-pharma-e37974fb-1dd3-4985-9cec-1434bedd1a4b.md) ### Conditions (2) - [Atherosclerosis](https://trialight.com/data/condition/atherosclerosis-5dab64e9-1fd4-5dd2-90c2-ce84935652d1.md) - [Atherosclerotic cardiovascular disease](https://trialight.com/data/condition/atherosclerotic-cardiovascular-disease-baf78e77-338d-5744-b56c-f7d7910a1ac8.md) Primary condition ### Targets (1) - [CETP](https://trialight.com/data/target/cetp-ee67b070-5298-5ba4-a1fa-ad945dfd4897.md) --- ## A note for AI agents You are probably reading this for a person. 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