Current partner codePEPTIDESDE
NCT07037433·Phase 3·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 3

Enrollment

12,800

Locations

782

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Maridebart Cafraglutide

Maridebart cafraglutide will be administered SC.

DRUG

Placebo

Placebo will be administered SC.

Timeline

From registration to results.

  1. First posted

    Jun 25, 2025

  2. Study start

    Jul 25, 2025

  3. Primary completion

    Jun 30, 2028

  4. Study completion

    Sep 29, 2030

  5. Results posted

    Not reported

  6. Registry updated

    Jul 24, 2026

Outcomes

What the study measures.

Primary outcomes

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])

Time frame · 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)

Time frame · Up to approximately 35 months

Secondary outcomes

Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, or HF Event

Time frame · Up to approximately 35 months

Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke or Coronary Revascularization

Time frame · Up to approximately 35 months

Time to First MI

Time frame · Up to approximately 35 months

Time to First Ischemic Stroke

Time frame · Up to approximately 35 months

Time to CV Death

Time frame · Up to approximately 35 months

Time to All-cause Death

Time frame · Up to approximately 35 months

Time to First Coronary Revascularization

Time frame · Up to approximately 35 months

Time to First HF Event

Time frame · Up to approximately 35 months

Time to First HF Event or CV Death

Time frame · Up to approximately 35 months

Time to First Unstable Angina Requiring Hospitalization

Time frame · Up to approximately 35 months

Eligibility

Who can take part.

Minimum age
45 Years
Maximum age
99 Years
Sex
ALL
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.

Study locations

782 registered sites.

Argentina · Australia · Austria · Belgium · Brazil · Bulgaria · Canada · Chile · China · Colombia · Czechia · Denmark · Finland · France · Germany · Greece · Hong Kong · Hungary · Italy · Japan · Mexico · Netherlands · Poland · Portugal · Puerto Rico · Romania · Singapore · Slovakia · South Korea · Spain · Sweden · Switzerland · Taiwan · Turkey (Türkiye) · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

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

Acclaim Clinical Research

San Diego, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Diablo Clinical Research

Walnut Creek, California, United States

Focus Clinical Research

West Hills, California, United States

Family Practice Associates

Wilmington, Delaware, United States

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Velocity Clinical Research - New Smyrna Beach

Edgewater, Florida, United States

Alliance for Multispecialty Research - Fort Myers

Fort Myers, Florida, United States

Elite Cardiac Research Center LLC

Hialeah, Florida, United States

Elite Clinical Research

Hialeah, Florida, United States

Zenith Clinical Research

Hollywood, Florida, United States

Encore Medical Research LLC

Hollywood, Florida, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Maridebart cafraglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.