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Maridebart cafraglutide to reduce heart-related events in people with atherosclerotic cardiovascular disease and overweight or obesity

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity

PHASE3 · Amgen · NCT07037433

This will test whether maridebart cafraglutide added to usual care can reduce heart attacks, strokes, and cardiovascular deaths in adults 45 and older with atherosclerotic cardiovascular disease who are overweight or have obesity.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment12800 (estimated)
Ages45 Years to 99 Years
SexAll
SponsorAmgen (industry)
Locations765 sites (Daphne, Alabama and 764 other locations)
Trial IDNCT07037433 on ClinicalTrials.gov

What this trial studies

This is a phase 3, randomized, double-blind, placebo-controlled trial comparing maridebart cafraglutide versus placebo added to standard of care in adults with established atherosclerotic cardiovascular disease and BMI ≥27 kg/m2. Participants who meet inclusion criteria (age ≥45 and prior MI, ischemic stroke, or symptomatic PAD) are randomized and followed for major adverse cardiovascular events including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. Key exclusions include recent acute cardiovascular events or procedures within 60 days before screening. The primary goal is to show superiority of maridebart cafraglutide over placebo in reducing cardiovascular morbidity and mortality.

Who should consider this trial

Good fit: Ideal candidates are adults aged 45 or older with established atherosclerotic cardiovascular disease and a BMI of 27 kg/m2 or higher who have been free of major cardiovascular events for at least 60 days.

Not a fit: People who had a heart attack, stroke, arterial revascularization, major cardiovascular surgery, hospitalization for unstable angina, or TIA within 60 days or who do not meet the ASCVD or BMI criteria are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, maridebart cafraglutide could lower the risk of heart attacks, strokes, and cardiovascular death in people with ASCVD who are overweight or obese.

How similar studies have performed: Other GLP-1–based therapies have demonstrated cardiovascular benefit in high-risk patients, but maridebart cafraglutide is a newer agent being tested specifically for hard cardiovascular outcomes.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

* 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 Criteria

* 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.

Where this trial is running

Daphne, Alabama and 764 other locations

+715 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Atherosclerotic Cardiovascular Disease, Overweight, Obesity, Maridebart cafraglutide, AMG 133, MariTide

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.