DRUG
Maridebart Cafraglutide
Maridebart cafraglutide will be administered SC.
Status
Recruiting
Phase
Phase 3
Enrollment
12,800
Locations
782
Results
Not posted
Publications
0
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.
Interventions
DRUG
Maridebart cafraglutide will be administered SC.
DRUG
Placebo will be administered SC.
Timeline
First posted
Jun 25, 2025
Study start
Jul 25, 2025
Primary completion
Jun 30, 2028
Study completion
Sep 29, 2030
Results posted
Not reported
Registry updated
Jul 24, 2026
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
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
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
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
No PMID-linked publications were present in this registry snapshot.
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