This study focuses on people with atherosclerotic cardiovascular disease (a condition where arteries become hardened and narrowed) who are also overweight or have obesity. The purpose is to evaluate whether a new medication called maridebart cafraglutide (also known as AMG 133) can help reduce heart and blood vessel-related health problems compared to placebo when added to standard treatments.
The medication is given as a solution for injection under the skin (subcutaneous use). During the study, participants will receive either maridebart cafraglutide or placebo. The study will track important heart-related events that may occur, such as heart attacks, strokes, and the need for heart procedures.
The research team will monitor participants’ health throughout the study, focusing particularly on heart and blood vessel-related events. The study will look at whether the medication can help prevent serious heart problems and improve survival rates in people who have both cardiovascular disease and weight issues.
1Initial screening
You will undergo an initial screening to confirm eligibility for the study.
The screening will verify if you meet the following criteria: age 45 years or older, body mass index (BMI) of 27 or higher, and history of atherosclerotic cardiovascular disease.
Your cardiovascular history must include at least one of these conditions: previous heart attack, previous ischemic stroke, or symptoms of peripheral arterial disease.
2Treatment assignment
You will be randomly assigned to receive either maridebart cafraglutide or a placebo.
The assignment will be double-blind, meaning neither you nor the study staff will know which treatment you are receiving.
The medication will be provided as an injectable solution for subcutaneous use (injection under the skin).
3Treatment period
The study will continue from October 2025 until September 2030.
Throughout the study period, you will receive regular injections of either the study medication or placebo.
The treatment will be given in addition to your standard cardiovascular care.
4Monitoring
Your cardiovascular health will be monitored throughout the study period.
The study will track any occurrence of heart-related events, including: cardiovascular death, heart attack, ischemic stroke, coronary procedures, or heart failure.
Regular health assessments will be conducted to monitor your overall condition.
Who Can Join the Study?
You must sign an informed consent document before any study procedures begin
You must be 45 years or older at the time of screening
Your Body Mass Index (BMI) must be 27 or higher at screening (BMI is a measure of body fat based on height and weight)
You must have a history of atherosclerotic cardiovascular disease with at least one of these conditions:
Previous heart attack (myocardial infarction)
Previous ischemic stroke (a type of stroke caused by blocked blood flow to the brain)
Symptoms of peripheral arterial disease (PAD), which includes:
Pain while walking (intermittent claudication) with an ankle-brachial index less than 0.9 at rest (a test that compares blood pressure in your ankle to your arm)
Previous surgery to improve blood flow in leg arteries
Previous amputation due to blocked arteries
Who Cannot Join the Study?
History of severe allergic reactions to similar medications
Participation in any other clinical trial within the past 30 days
Uncontrolled diabetes (blood sugar levels that remain high despite treatment)
Severe kidney disease requiring dialysis (a treatment that filters blood when kidneys don’t work properly)
Severe liver problems or abnormal liver function tests
History of pancreatic disease or inflammation of the pancreas
Active cancer or cancer treatment within the past 5 years (except for certain skin cancers)
History of major surgery of the stomach or intestines
Unstable heart conditions such as recent heart attack or severe heart failure
History of mental health conditions that could interfere with study participation
Current drug or alcohol abuse
Pregnancy, breastfeeding, or planning to become pregnant during the study period
Unable to follow study procedures or attend scheduled visits
Maridebart cafraglutide is an investigational medication being studied for reducing cardiovascular problems in people who have atherosclerotic cardiovascular disease (hardening of the arteries) and are overweight or obese. This medication is being tested to see if it can help lower the risk of heart-related health issues and death when used alongside standard treatments. It belongs to a class of medications that may help with both weight management and cardiovascular health.
Atherosclerotic Cardiovascular Disease (ASCVD) – A condition where fatty deposits (plaque) build up inside the arteries, causing them to narrow and harden over time. The plaque accumulation occurs gradually and can affect arteries throughout the body, particularly those supplying blood to the heart and brain. This process begins when cholesterol and other substances collect in the artery walls, leading to inflammation and eventual hardening of the vessels. The narrowed arteries make it harder for blood to flow through them, which can reduce oxygen delivery to various organs and tissues. This disease often develops silently over many years before causing noticeable symptoms.
Obesity – A complex medical condition characterized by an excessive accumulation of body fat that can affect overall health. The condition develops when the body consistently takes in more calories than it burns through normal daily activities and exercise. Obesity is typically measured using body mass index (BMI), with a BMI of 30 or greater indicating obesity. The condition can affect multiple body systems and often develops gradually over time.
Overweight – A condition where a person’s body weight is higher than what is considered healthy for their height, but not as severe as obesity. It is typically defined by a body mass index (BMI) between 25 and 29.9. The condition results from an energy imbalance where caloric intake exceeds caloric expenditure over an extended period. This state can be a precursor to obesity if the weight continues to increase.
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