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

NCT05202509
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
9,541
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Lead sponsor
NewAmsterdam Pharma
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Start date
2022-02-07
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Number of sites
591
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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.
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Acronym
PREVAIL
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Short title
Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2026-11-01
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First posted
2022-01-21
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Registry last updated
2024-06-04
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Primary completion date
2026-11-01
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Start date
2022-02-07
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Actual participants
9,541
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Participants
9,541
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
591
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
NewAmsterdam Pharma
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05202509
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ClinicalTrials.gov ID
NCT05202509
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Registry record
Open registry record
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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
clinicaltrials.gov

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (2)

Targets (1)