The trial is taking place at:
E

Endocrine Research Solutions | Roswell, GA

Veeva-enabled site

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

N

NewAmsterdam Pharma

Status and phase

Enrolling
Phase 3

Conditions

Atherosclerotic Cardiovascular Disease

Treatments

Drug: Placebo
Drug: Obicetrapib

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

9,000 estimated 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

9,000 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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