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Clinical Trials in the USA / NCT07037433
Recruiting Phase 3

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

NCT07037433 · tracked via the Priya Life Science USA tracker
Sponsor
Amgen
Phase
Phase 3
Started
2025-07-25
Last updated
2026-09-03

Condition(s) studied

Atherosclerotic Cardiovascular DiseaseOverweightObesity

Investigational drug(s) / intervention(s)

Maridebart CafraglutidePlacebo

Maridebart Cafraglutide: Maridebart cafraglutide will be administered SC.

Placebo: Placebo will be administered SC.

Study summary

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.

Eligibility

Sex
ALL
Min age
45 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (783)

FacilityCityRegionStatus
Alliance For Multispecialty Research - Daphne Daphne Alabama Recruiting
Eastern Shore Research Institute Fairhope Alabama Recruiting
Heart Center Research LLC Huntsville Alabama Recruiting
Mobile Heart Specialists PC Mobile Alabama Recruiting
Syed Research Consultants LLC Sheffield Alabama Recruiting
Synexus Clinical Research US, Inc. Phoenix Arizona Recruiting
Medical Advancement Centers of Arizona Phoenix Arizona Recruiting
Valley Clinical Trials, LLC dba Flourish Research Covina California Recruiting
Velocity Clinical Research- Huntington Park Huntington Park California Recruiting
Velocity Clinical Research- Los Angeles La Mesa California Completed
Orange County Research Center Lake Forest California Recruiting
Biopharma Informatic - The Cardiovascular Center Redding California Recruiting
Acclaim Clinical Research San Diego California Recruiting
Encompass Clinical Research Spring Valley California Recruiting
Diablo Clinical Research Walnut Creek California Recruiting
Focus Clinical Research West Hills California Recruiting
Family Practice Associates Wilmington Delaware Recruiting
Excel Medical Clinical Trials Boca Raton Florida Recruiting
Velocity Clinical Research - New Smyrna Beach Edgewater Florida Recruiting
Alliance for Multispecialty Research - Fort Myers Fort Myers Florida Recruiting
Elite Cardiac Research Center LLC Hialeah Florida Recruiting
Elite Clinical Research Hialeah Florida Recruiting
Zenith Clinical Research Hollywood Florida Recruiting
Encore Medical Research LLC Hollywood Florida Recruiting
East Coast Institute for Research, LLC Jacksonville Florida Recruiting
Clinical Research of Central Florida Lakeland Florida Recruiting
South Florida Clinical Research Margate Florida Recruiting
Finlay Medical Research Miami Florida Recruiting
Suncoast Research Group LLC Miami Florida Recruiting
New Horizon Research Center Miami Florida Recruiting
Panax Clinical Research Miami Lakes Florida Recruiting
San Marcus Research Clinic Inc Miami Lakes Florida Recruiting
Indago Research and Health Center Miami Lakes Florida Recruiting
West Orange Endocrinology Ocoee Florida Recruiting
Cardiology Partners Clinical Research Institute Palm Beach Gardens Florida Recruiting
Peace River Cardiovascular Center Port Charlotte Florida Recruiting
Progressive Medical Research Port Orange Florida Recruiting
Saint Johns Center for Clinical Research Saint Augustine Florida Recruiting
Intercoastal Medical Group Sarasota Florida Recruiting
Winter Haven Hospital Winter Haven Florida Recruiting

+ 743 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07037433 on ClinicalTrials.gov ↗ ← All trials in the USA