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

What this study is about

The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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

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

+ 762 more sites.

Who to contact

Amgen Call Center · 866-572-6436 · medinfo@amgen.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07037433.