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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 : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Atherosclerotic Cardiovascular Disease Drug: Obicetrapib Drug: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9000 participants
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
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
Actual Study Start Date : February 7, 2022
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Arm Intervention/treatment
Experimental: obicetrapib 10mg
one 10mg tablet, once daily.
Drug: Obicetrapib
10mg obicetrapib tablet

Placebo Comparator: Placebo
one placebo tablet, once daily
Drug: Placebo
Placebo tablet to resemble obicetrapib




Primary Outcome Measures :
  1. Major Adverse Cardiovascular Effect (MACE) [ Time Frame: 32 months after last participant randomized ]
    To evaluate the effect of obicetrapib on the risk of MACE



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≥ 70 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05202509


Contacts
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Contact: Kelly Millhaem 513-579-9911 k.millhaem@medpace.com

Locations
Show Show 77 study locations
Sponsors and Collaborators
NewAmsterdam Pharma
Investigators
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Study Director: Marc Ditmarsch, MD NewAmsterdam Pharma
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Responsible Party: NewAmsterdam Pharma
ClinicalTrials.gov Identifier: NCT05202509    
Other Study ID Numbers: TA-8995-304
First Posted: January 21, 2022    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases