Actively Recruiting
Phase 3 Study of Maridebart Cafraglutide Compared to Placebo in Patients With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Led by Amgen · Updated on 2026-05-29
12800
Participants Needed
772
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating maridebart cafraglutide in adults aged 45 to 99 years who have atherosclerotic cardiovascular disease and are overweight or obese. The study aims to determine if maridebart cafraglutide, when added to standard care, is better than a placebo in reducing serious heart-related problems and deaths. This is a Phase 3 randomized, double-blind, placebo-controlled trial sponsored by Amgen. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given as subcutaneous injections. The study treatment is given alongside their usual care. The trial will last for approximately 35 months, during which time researchers will monitor cardiovascular events such as heart attacks, strokes, and deaths, as well as other health measures. During the study, participants will have regular visits for monitoring safety and health status. Researchers will assess heart-related events, blood pressure, body measurements, blood markers such as cholesterol and blood sugar levels, and kidney function. The main outcomes include time to first major cardiovascular event and changes in various health indicators over about three years. Safety monitoring will continue throughout the trial period.
CONDITIONS
Brief Title
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 45 years or older at screening
- Body mass index (BMI) of 27.0 kg/m² or higher at screening
- History of atherosclerotic cardiovascular disease with at least one of the following: prior heart attack, prior ischemic stroke, or symptomatic peripheral arterial disease confirmed by specific tests or procedures
You will not qualify if you...
- Recent (within 60 days) heart attack, unstable angina hospitalization, arterial revascularization, major cardiovascular surgery, stroke, or transient ischemic attack
- Severe heart failure classified as New York Heart Association class IV or recent heart failure hospitalization within 60 days
- Type 1 diabetes or any diabetes other than type 2 diabetes or prior gestational diabetes
- For type 2 diabetes patients: HbA1c above 10.0% at screening, recent diabetic ketoacidosis, severe hypoglycemia history, or serious diabetic eye disease
- Use of certain diabetes-related drugs like GLP-1 receptor agonists or amylin analogs within 90 days before randomization
- History of pancreatitis within 180 days before screening
- Personal or family history of specific thyroid cancers or endocrine syndromes
- Certain liver diseases or abnormal liver function tests
- History of cancer within 5 years, except certain treated skin or in situ cancers
- Women of childbearing potential planning pregnancy or unwilling to use specified contraception during the study
Research Team
A
Amgen Call Center
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