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The trial is taking place at:
A

Alpine Research Organization | Clinton, UT

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

N

NewAmsterdam Pharma

Status and phase

Active, not recruiting
Phase 3

Conditions

Atherosclerotic Cardiovascular Disease

Treatments

Drug: Obicetrapib
Drug: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05202509
TA-8995-304

Details and patient eligibility

About

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.

Full 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

Enrollment

9,541 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

9,541 participants in 2 patient groups, including a placebo group

obicetrapib 10mg
Experimental group
Description:
one 10mg tablet, once daily.
Treatment:
Drug: Obicetrapib
Placebo
Placebo Comparator group
Description:
one placebo tablet, once daily
Treatment:
Drug: Placebo

Trial contacts and locations

592

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Central trial contact

Andrea Flannery

Data sourced from clinicaltrials.gov

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