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 (PREVAIL)

  • STATUS
    Recruiting
  • End date
    Dec 28, 2026
  • participants needed
    9000
  • sponsor
    NewAmsterdam Pharma
Updated on 28 October 2022

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.

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

Details
Condition Atherosclerotic Cardiovascular Disease
Treatment Placebo, Obicetrapib
Clinical Study IdentifierNCT05202509
SponsorNewAmsterdam Pharma
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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