Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
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)
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]) — 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) — Up to approximately 35 months
Trial sites (783)
Facility
City
Region
Status
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.
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