RecruitingPHASE3INTERVENTIONAL

Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity

This study is looking into a new medication called Maridebart Cafraglutide. It's for people who have heart disease, specifically a condition called atherosclerotic cardiovascular disease, and are also overweight or obese. The main aim is to see if this new drug, when taken alongside their usual care, is better than a dummy pill (placebo) at reducing serious heart-related issues like heart attacks, strokes, or even death. Researchers want to make sure it's safe and effective in improving heart health for this group of patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Amgen

Enrolment target

12,800

Start

25 Jul 2025

Estimated completion

29 Sep 2030

Atherosclerotic Cardiovascular Disease Overweight Obesity

What is this study about?

This study is called 'Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity'. This means it’s looking at how a new drug, Maridebart Cafraglutide, affects people who have a specific type of heart disease where their arteries have hardened and narrowed (atherosclerotic cardiovascular disease), and who are also overweight or obese.

The main purpose is to find out if taking Maridebart Cafraglutide, in addition to the care you already receive for your heart condition, can help prevent serious heart-related problems. This includes things like having another heart attack, experiencing a stroke, or even reducing the risk of dying from heart disease. The researchers want to see if this new medicine can offer better protection than a placebo, which is a dummy pill that contains no active drug.

By comparing the new drug to a placebo, the study can clearly show if Maridebart Cafraglutide is truly effective. Finding new ways to protect the hearts of people with existing heart disease and who are overweight or obese is very important for improving their health and quality of life.

Key takeaways

This study is testing a new drug for heart disease patients who are also overweight or obese.
It aims to see if the drug can lower the risk of serious heart problems like heart attacks and strokes.
Participants will receive either the new drug or a dummy pill (placebo).
You will continue to take your regular heart medications.
Regular health checks and follow-up visits will be part of the study.
The study seeks to improve heart health for people with specific, existing conditions.

Who may be eligible?

To join this study, you generally need to be at least 45 years old. You also need to have a body mass index (BMI) of 27 or higher, which indicates you are overweight or obese.

Crucially, you must have a history of atherosclerotic cardiovascular disease. This means you would have already experienced a heart attack, an ischemic stroke (a stroke caused by a blood clot), or have symptomatic peripheral arterial disease (poor circulation in your legs causing pain when walking).

There are also some reasons why you might not be able to join. For example, if you've had a recent heart attack, stroke, or major heart surgery within the last two months, you won't be eligible. The study also cannot include individuals with severe heart failure, type 1 diabetes, or poorly controlled type 2 diabetes, or those who have recently had severe low blood sugar episodes. If you have serious eyesight problems due to diabetes, you also cannot participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 45 years old?
Is your BMI 27 or higher (indicating you're overweight or obese)?
Have you been diagnosed with atherosclerotic cardiovascular disease (e.g., had a heart attack, certain type of stroke, or peripheral artery disease)?
Have you NOT had a recent heart attack, stroke, or major heart surgery in the last 2 months?
Do you NOT have severe heart failure or type 1 diabetes?
Is your type 2 diabetes well-controlled (if you have it)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the new drug, Maridebart Cafraglutide, or a placebo (a dummy pill). You wouldn't know which one you are getting, and neither would your study doctor. This is standard practice in clinical trials and helps ensure fair results.

Throughout the study, you would continue to receive your usual medical care from your own doctors. You would also have regular visits to the study clinic for health check-ups, blood tests, and other assessments to monitor your health and how the treatment is working. The study team would provide all the necessary information and support you need. The total duration of your participation would be explained to you by the study team.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as contributing to medical knowledge and potentially helping future patients. While unlikely, it's possible you might find that the study medication helps manage your heart condition. However, there's also a chance you could get the placebo and not receive any active treatment from the study drug. All medications have potential side effects, and while the study team would monitor you closely, you might experience some. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (774)

Alliance For Multispecialty Research - Daphne
Verified postcode
Daphne, United States· Recruiting
Eastern Shore Research Institute
Verified postcode
Fairhope, United States· Recruiting
Heart Center Research LLC
Verified postcode
Huntsville, United States· Recruiting
Mobile Heart Specialists PC
Verified postcode
Mobile, United States· Recruiting
Syed Research Consultants LLC
Verified postcode
Sheffield, United States· Recruiting
Synexus Clinical Research US, Inc.
Verified postcode
Phoenix, United States· Recruiting
Medical Advancement Centers of Arizona
Verified postcode
Phoenix, United States· Recruiting
Valley Clinical Trials, LLC dba Flourish Research
Verified postcode
Covina, United States· Recruiting
Velocity Clinical Research- Huntington Park
Verified postcode
Huntington Park, United States· Recruiting
Velocity Clinical Research- Los Angeles
Verified postcode
La Mesa, United States· Completed
Orange County Research Center
Verified postcode
Lake Forest, United States· Recruiting
Biopharma Informatic - The Cardiovascular Center
Verified postcode
Redding, United States· Recruiting

Common questions

What is 'atherosclerotic cardiovascular disease'?

It's a common type of heart disease where fatty deposits build up and harden your arteries, making them narrower. This can lead to heart attacks and strokes.

What is a 'placebo'?

A placebo is a 'dummy pill' that looks exactly like the study drug but contains no active medicine. It helps researchers compare the real drug's effects accurately.

Will I know if I'm getting the real drug or the placebo?

No, you won't. This is called 'blinding' and it's a standard and important part of clinical trials to ensure the results are fair and unbiased.

Do I have to stop my usual heart medicines if I join?

No, the study medication is given 'as an adjunct to standard of care,' meaning you would continue with your regular medicines for your heart condition as prescribed by your doctor.

What is a BMI of '27 or higher'?

BMI stands for Body Mass Index. A BMI of 27 or higher means you are considered overweight or obese based on a calculation of your height and weight.

How to find out more

Amgen Call Center

medinfo@amgen.com 866-572-6436 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.