Maridebart Cafraglutide for Heart Disease and Overweight/Obesity
This study is testing a drug called maridebart cafraglutide to see if it can reduce serious heart problems like heart attack, stroke, or death in people who have atherosclerotic cardiovascular disease (a condition where plaque builds up in your arteries) and are also overweight or obese. The study aims to show that maridebart cafraglutide is better than a placebo (an inactive substance) when added to your usual care. You may be able to join if you are between 45 and 99 years old, have a BMI (Body Mass Index) of 27 or higher, and have a history of atherosclerotic cardiovascular disease, such as a previous heart attack. The study plans to enroll 12,800 participants. The current recruitment status is unclear.
- Study design
- This is an interventional study comparing maridebart cafraglutide to a placebo. It plans to enroll 12,800 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to approximately 35 months to track cardiovascular events.
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NCT07037433
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Recruiting
PHASE3Ages 45–99InterventionalTreatmentAmgen
~12,800 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Maridebart CafraglutidePlacebo
At a glance
Recruiting sites
776 of 782 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, Myocardial Infarction (MI), or Ischemic Stroke (3-point Major Adverse Cardiac Events [3-P MACE])
Measured over Up to approximately 35 months
+1 more outcome measured
Conditions
Where it's being run
782 sites across 163 statesCzechia41
Germany39
Poland39
Hungary32
Netherlands31
United Kingdom28
Texas25
Florida23
Study leadership
- MD · STUDY_DIRECTOR · Amgen
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Age ≥ 45 years at screening.
BMI of ≥ 27.0 kg/m\^2 at screening.
History of Atherosclerotic Cardiovascular Disease (ASCVD) with a documented history of at least one of the following:
Prior MI (presumed atherothrombotic event due to plaque rupture/erosion).
Prior ischemic stroke (presumed due to atherosclerosis; may include ischemic stroke with hemorrhagic transformation).
Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) \< 0.9 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease.
Exclusion
History of any of the following within 60 days before screening or between screening and randomization: MI, hospitalization for unstable angina, arterial revascularization (eg, coronary, cerebrovascular or peripheral) major cardiovascular surgery, stroke, or transient ischemic attack (TIA).
New York Heart Association (NYHA) class IV HF during screening or hospitalization for HF within 60 days before screening or between screening and randomization.
Type 1 DM, or any other type of diabetes with the exception of T2DM or prior gestational diabetes. Participants with a history of gestational diabetes should be stratified according to their current diabetes classification.
For participants with T2DM (including those without a prior history of T2DM but with a HbA1c ≥ 6.5% during screening):
HbA1c \> 10.0% (86 mmol/mol) at screening.
History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization.
One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness.
History of proliferative diabetic retinopathy, diabetic maculopathy, severe non-proliferative diabetic retinopathy, or currently receiving or planning to receive treatment for diabetic retinopathy and/or diabetic macular edema.
Use of any glucagon-like peptide-1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days before randomization or planned use during the conduct of the trial.
History of chronic pancreatitis or history of acute pancreatitis in the 180 days before screening or between screening and randomization.
Family (first-degree relative\[s\]), or personal history of medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia syndrome type 2 (MEN-2).
Calcitonin ≥ 50 ng/L (pg/mL) at screening.
Acute or chronic hepatitis; signs and symptoms of any liver disease other than metabolic dysfunction-associated steatotic liver disease, or alanine aminotransferase (ALT) \> 3.0 x the upper limit of normal (ULN) during screening, or total bilirubin (TBL) \> 1.8 x ULN during screening (for participants with a known diagnosis of Gilbert syndrome, direct bilirubin should be used instead of TBL).
History of malignancy within the last 5 years before screening or between screening and randomization (except for the following treated with curative intent: non-melanoma skin cancer, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ).
Participants of childbearing potential planning to become pregnant while on study or unwilling to use protocol-specified methods of contraception during treatment.
What this trial measures
- Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, Myocardial Infarction (MI), or Ischemic Stroke (3-point Major Adverse Cardiac Events [3-P MACE])Up to approximately 35 months
- Time to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, MI, Ischemic Stroke, Coronary Revascularization, or Heart Failure (HF) Event (5-point MACE)Up to approximately 35 months