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

a study on Cardiovascular Disease Atherosclerosis Peripheral Artery Disease

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by French (ucla)

Description

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.

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

Details

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

Keywords

Atherosclerotic Cardiovascular Disease, Cardiovascular Diseases, Atherosclerosis, Obicetrapib, obicetrapib 10mg

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • Westside Medical Associates of Los Angeles accepting new patients
    Beverly Hills California 90211 United States
  • American Institute of Research accepting new patients
    Los Angeles California 90211 United States
  • Hope Clinical Research LLC accepting new patients
    Canoga Park California 91303 United States
  • Titan Medical Research - Oceanside accepting new patients
    Encinitas California 92024 United States
  • Amicis Research Center-Northridge accepting new patients
    Northridge California 91324 United States
  • Amicis Research accepting new patients
    Northridge California 91324 United States
  • Valley Clinical Trials, Inc accepting new patients
    Northridge California 91325 United States
  • Advanced Research Center accepting new patients
    Anaheim California 92805 United States
  • Torrance Clinical Research Institute Inc. accepting new patients
    Lomita California 90717 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NewAmsterdam Pharma
ID
NCT05202509
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 9000 study participants
Last Updated