Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Recruiting · NCT07037433 · Interventional (participants receive a specific treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
Maridebart CafraglutidePlacebo
What this trial 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 take part
Age range
45 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 36 US states.
- 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
- East Coast Institute for Research, LLC - Jacksonville, Florida, United States
- Clinical Research of Central Florida - Lakeland, Florida, United States
- South Florida Clinical Research - Margate, Florida, United States
- Finlay Medical Research - Miami, Florida, United States
- Suncoast Research Group LLC - Miami, Florida, United States
- New Horizon Research Center - Miami, Florida, United States
- Panax Clinical Research - Miami Lakes, Florida, United States
- San Marcus Research Clinic Inc - Miami Lakes, Florida, United States
- Indago Research and Health Center - Miami Lakes, Florida, United States
- West Orange Endocrinology - Ocoee, Florida, United States
- Cardiology Partners Clinical Research Institute - Palm Beach Gardens, Florida, United States
- Peace River Cardiovascular Center - Port Charlotte, Florida, United States
- Progressive Medical Research - Port Orange, Florida, United States
- Saint Johns Center for Clinical Research - Saint Augustine, Florida, United States
- Intercoastal Medical Group - Sarasota, Florida, United States
- Winter Haven Hospital - Winter Haven, Florida, United States
- East Coast Institute for Research LLC at Canton Georgia - Canton, Georgia, United States
- The Jones Center Clinical Research - Macon, Georgia, United States
- Velocity Clinical Research - Savannah - Savannah, Georgia, United States
- Velocity Clinical Research - Boise - Meridian, Idaho, United States
- Endeavor Health-Northwest Community Healthcare - Arlington Heights, Illinois, United States
- Eagle Clinical Research - Chicago, Illinois, United States
- University of Chicago - Chicago, Illinois, United States
- Alliance For Multispecialty Research - Oak Brook - Oak Brook, Illinois, United States
- Prarie Education and Research - Springfield, Illinois, United States
- Cardiovascular Research of Northwest Indiana LLC - Munster, Indiana, United States
- Velocity Clinical Research - Valparaiso - Valparaiso, Indiana, United States
- McFarland Clinic PC - Ames, Iowa, United States
- Midwest Cardiovascular Research Foundation - Davenport, Iowa, United States
- Cotton-ONeil Diabetes and Endocrinology Center - Topeka, Kansas, United States
- Monroe Biomedical Research - Louisville, Kentucky, United States
- Cardiovascular Associates Research, LLC - Covington, Louisiana, United States
- Tandem Clinical Research - Marrero - Marrero, Louisiana, United States
- Ascension Saint Agnes Heart Care - Baltimore, Maryland, United States
- MD Medical Research - Oxon Hill, Maryland, United States
- Velocity Clinical Research - Rockville - Rockville, Maryland, United States
Showing 60 of 782 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →