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

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ClinicalTrials.gov Identifier: NCT05202509
Recruitment Status : Recruiting
First Posted : January 21, 2022
Last Update Posted : March 5, 2024
Sponsor:
Collaborator:
Monash University
Information provided by (Responsible Party):
NewAmsterdam Pharma

Tracking Information
First Submitted Date  ICMJE November 22, 2021
First Posted Date  ICMJE January 21, 2022
Last Update Posted Date March 5, 2024
Actual Study Start Date  ICMJE February 7, 2022
Estimated Primary Completion Date November 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2024)
Major Adverse Cardiovascular Effect (MACE) [ Time Frame: 30 months after last participant randomized ]
To evaluate the effect of obicetrapib on the risk of MACE
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2022)
Major Adverse Cardiovascular Effect (MACE) [ Time Frame: 32 months after last participant randomized ]
To evaluate the effect of obicetrapib on the risk of MACE
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Placebo-Controlled, Double-Blind, Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Matching placebo to active
Primary Purpose: Treatment
Condition  ICMJE Atherosclerotic Cardiovascular Disease
Intervention  ICMJE
  • Drug: Obicetrapib
    10mg obicetrapib tablet
  • Drug: Placebo
    Placebo tablet to resemble obicetrapib
Study Arms  ICMJE
  • Experimental: obicetrapib 10mg
    one 10mg tablet, once daily.
    Intervention: Drug: Obicetrapib
  • Placebo Comparator: Placebo
    one placebo tablet, once daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 20, 2022)
9000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2026
Estimated Primary Completion Date November 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrea Flannery +44 0755 7544789 a.flannery@medpace.com
Listed Location Countries  ICMJE Australia,   Bulgaria,   Canada,   China,   Croatia,   Czechia,   Denmark,   Finland,   Georgia,   Germany,   Hungary,   Israel,   Italy,   Japan,   Jordan,   Latvia,   Netherlands,   Poland,   Slovakia,   South Africa,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05202509
Other Study ID Numbers  ICMJE TA-8995-304
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party NewAmsterdam Pharma
Original Responsible Party Same as current
Current Study Sponsor  ICMJE NewAmsterdam Pharma
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Monash University
Investigators  ICMJE
Study Director: Marc Ditmarsch, MD NewAmsterdam Pharma
PRS Account NewAmsterdam Pharma
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP