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

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

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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