Recruiting
Phase 3

Maridebart Cafraglutide

Sponsor:

Amgen

Code:

NCT07037433

Conditions

Atherosclerotic Cardiovascular Disease

Overweight

Obesity

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Maridebart Cafraglutide

Placebo

Study Details

Brief 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.

Conditions

Atherosclerotic Cardiovascular Disease

Overweight

Obesity

Study ID

NCT07037433

Start date

Jul 25, 2025

Status verified date

Sep, 2026

Completion date

Sep 29, 2030

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

12800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Maridebart Cafraglutide

Participants will receive maridebart cafraglutide subcutaneously (SC).

placebo comparator: Placebo

Participants will receive placebo SC.

Interventions

Maridebart Cafraglutide

Maridebart cafraglutide will be administered SC.

Placebo

Placebo will be administered SC.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Alliance For Multispecialty Research - Daphne

Recruiting

Daphne, Alabama, United States, 36526

Eastern Shore Research Institute

Recruiting

Fairhope, Alabama, United States, 36532

Heart Center Research LLC

Recruiting

Huntsville, Alabama, United States, 35801

Mobile Heart Specialists PC

Recruiting

Mobile, Alabama, United States, 36608

Syed Research Consultants LLC

Recruiting

Sheffield, Alabama, United States, 35660

Synexus Clinical Research US, Inc.

Recruiting

Phoenix, Arizona, United States, 85020

Medical Advancement Centers of Arizona

Recruiting

Phoenix, Arizona, United States, 85044

Valley Clinical Trials, LLC dba Flourish Research

Recruiting

Covina, California, United States, 91723

Velocity Clinical Research- Huntington Park

Recruiting

Huntington Park, California, United States, 90255

Orange County Research Center

Recruiting

Lake Forest, California, United States, 92630

Biopharma Informatic - The Cardiovascular Center

Recruiting

Redding, California, United States, 96001

Acclaim Clinical Research

Recruiting

San Diego, California, United States, 92120

Encompass Clinical Research

Recruiting

Spring Valley, California, United States, 91978

Diablo Clinical Research

Recruiting

Walnut Creek, California, United States, 94598

Focus Clinical Research

Recruiting

West Hills, California, United States, 91307

Family Practice Associates

Recruiting

Wilmington, Delaware, United States, 19805

Excel Medical Clinical Trials

Recruiting

Boca Raton, Florida, United States, 33434

Velocity Clinical Research - New Smyrna Beach

Recruiting

Edgewater, Florida, United States, 32132

Alliance for Multispecialty Research - Fort Myers

Recruiting

Fort Myers, Florida, United States, 33912

Elite Cardiac Research Center LLC

Recruiting

Hialeah, Florida, United States, 33013

Elite Clinical Research

Recruiting

Hialeah, Florida, United States, 33018

Zenith Clinical Research

Recruiting

Hollywood, Florida, United States, 33021

Encore Medical Research LLC

Recruiting

Hollywood, Florida, United States, 33024

East Coast Institute for Research, LLC

Recruiting

Jacksonville, Florida, United States, 32216

Clinical Research of Central Florida

Recruiting

Lakeland, Florida, United States, 33805

South Florida Clinical Research

Recruiting

Margate, Florida, United States, 33063

Finlay Medical Research

Recruiting

Miami, Florida, United States, 33126

Suncoast Research Group LLC

Recruiting

Miami, Florida, United States, 33135

New Horizon Research Center

Recruiting

Miami, Florida, United States, 33165

Panax Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33014

San Marcus Research Clinic Inc

Recruiting

Miami Lakes, Florida, United States, 33014

Indago Research and Health Center

Recruiting

Miami Lakes, Florida, United States, 33016

West Orange Endocrinology

Recruiting

Ocoee, Florida, United States, 34761

Cardiology Partners Clinical Research Institute

Recruiting

Palm Beach Gardens, Florida, United States, 33410

Peace River Cardiovascular Center

Recruiting

Port Charlotte, Florida, United States, 33952

Progressive Medical Research

Recruiting

Port Orange, Florida, United States, 32127

Saint Johns Center for Clinical Research

Recruiting

Saint Augustine, Florida, United States, 32086

Intercoastal Medical Group

Recruiting

Sarasota, Florida, United States, 34239

Winter Haven Hospital

Recruiting

Winter Haven, Florida, United States, 33881

East Coast Institute for Research LLC at Canton Georgia

Recruiting

Canton, Georgia, United States, 30114

The Jones Center Clinical Research

Recruiting

Macon, Georgia, United States, 31210

Velocity Clinical Research - Savannah

Recruiting

Savannah, Georgia, United States, 31419

Velocity Clinical Research - Boise

Recruiting

Meridian, Idaho, United States, 83642

Endeavor Health-Northwest Community Healthcare

Recruiting

Arlington Heights, Illinois, United States, 60005

Eagle Clinical Research

Recruiting

Chicago, Illinois, United States, 60621

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Alliance For Multispecialty Research - Oak Brook

Recruiting

Oak Brook, Illinois, United States, 60523

Prarie Education and Research

Recruiting

Springfield, Illinois, United States, 62701

Cardiovascular Research of Northwest Indiana LLC

Recruiting

Munster, Indiana, United States, 46321

Velocity Clinical Research - Valparaiso

Recruiting

Valparaiso, Indiana, United States, 46383

McFarland Clinic PC

Recruiting

Ames, Iowa, United States, 50010

Midwest Cardiovascular Research Foundation

Recruiting

Davenport, Iowa, United States, 52801

Cotton-ONeil Diabetes and Endocrinology Center

Recruiting

Topeka, Kansas, United States, 66606

Cardiovascular Associates Research, LLC

Recruiting

Covington, Louisiana, United States, 70433

Tandem Clinical Research - Marrero

Recruiting

Marrero, Louisiana, United States, 70072

Ascension Saint Agnes Heart Care

Recruiting

Baltimore, Maryland, United States, 21229

MD Medical Research

Recruiting

Oxon Hill, Maryland, United States, 20745

Velocity Clinical Research - Rockville

Recruiting

Rockville, Maryland, United States, 20854

Brigham and Womens Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Btc of New Bedford

Recruiting

New Bedford, Massachusetts, United States, 02740

Fairview Health Services M Health Fairview St Johns Hospital

Recruiting

Maplewood, Minnesota, United States, 55109

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Jackson Heart Clinic

Recruiting

Jackson, Mississippi, United States, 39216

Cardiology Associates of North Mississippi

Recruiting

Tupelo, Mississippi, United States, 38801

StudyMetrix Research

Recruiting

City of Saint Peters, Missouri, United States, 63303

Alliance for Multispecialty Research - Kansas City

Recruiting

Kansas City, Missouri, United States, 64114

Kansas City Veterans Affairs Medical Center

Recruiting

Kansas City, Missouri, United States, 64128

Saint Louis Heart and Vascular PC

Recruiting

St Louis, Missouri, United States, 63136

Bryan Heart

Recruiting

Lincoln, Nebraska, United States, 68506

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Primary Clinical Research

Recruiting

Papillion, Nebraska, United States, 68046

Excel Clinical Research

Recruiting

Las Vegas, Nevada, United States, 89109

Vector Clinical Trials

Recruiting

Las Vegas, Nevada, United States, 89128

CardioMetabolic Collaborative Clinic

Recruiting

Somerset, New Jersey, United States, 08873

Velocity Clinical Research - Binghamton

Recruiting

Binghamton, New York, United States, 13905

Hudson Valley Cardiovascular Practice PC

Recruiting

Poughkeepsie, New York, United States, 12601

Rochester Clinical Research

Recruiting

Rochester, New York, United States, 14609

Saratoga Clinical Research, LLC

Recruiting

Saratoga Springs, New York, United States, 12866

Southgate Medical Group

Recruiting

West Seneca, New York, United States, 14224

Novant Health Heart and Vascular Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Velocity Clinical Research - Durham

Recruiting

Durham, North Carolina, United States, 27701

Moses H Cone Memorial Hospital

Recruiting

Greensboro, North Carolina, United States, 27401

Monroe Biomedical Research

Recruiting

Monroe, North Carolina, United States, 28112

West Clinical Research

Recruiting

Morehead City, North Carolina, United States, 28557

Burke Primary Care Family Practice

Recruiting

Morganton, North Carolina, United States, 28655

Accellacare of Raleigh

Recruiting

Raleigh, North Carolina, United States, 27609

Accellacare of Piedmont Healthcare

Recruiting

Statesville, North Carolina, United States, 28625

Brookview Hills Research Associates Llc

Recruiting

Winston-Salem, North Carolina, United States, 27103

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Velocity Clinical Research - Cleveland

Recruiting

Beachwood, Ohio, United States, 44122

Aultman Hospital, Cardiovascular Consultants, Inc

Recruiting

Canton, Ohio, United States, 44710

Velocity Clinical Research - Auburn

Recruiting

Cincinnati, Ohio, United States, 45219

Endocrinology Associates Inc

Recruiting

Columbus, Ohio, United States, 43201

Nexgen Research

Recruiting

Lima, Ohio, United States, 45801

Heritage Valley Multispecialty Group Inc

Recruiting

Beaver, Pennsylvania, United States, 15009

Capital Area Research LLC

Recruiting

Camp Hill, Pennsylvania, United States, 17011

Abington Medical Specialists

Recruiting

Horsham, Pennsylvania, United States, 19044

Velocity Clinical Research - Providence

Recruiting

East Greenwich, Rhode Island, United States, 02818

Accellacare Charleston

Recruiting

Mt. Pleasant, South Carolina, United States, 29464

Monument Health Clinical Research

Recruiting

Rapid City, South Dakota, United States, 57701

Stern Cardiovascular Foundation Inc

Recruiting

Germantown, Tennessee, United States, 38138

Accellacare of Knoxville

Recruiting

Knoxville, Tennessee, United States, 37912

Cardiovascular Research of Knoxville North Knoxville Medical Center

Recruiting

Powell, Tennessee, United States, 37849

Tennessee Center for Clinical Trials

Recruiting

Tullahoma, Tennessee, United States, 37388

PharmaTex Research, LLC

Recruiting

Amarillo, Texas, United States, 79106

Austin Heart

Recruiting

Austin, Texas, United States, 78705

Velocity Clinical Research - Austin

Recruiting

Austin, Texas, United States, 78759

Thyroid Endocrinology and Diabetes

Recruiting

Dallas, Texas, United States, 75208

Soltero Cardiovascular Research Center

Recruiting

Dallas, Texas, United States, 75226

Zenos Clinical Research

Recruiting

Dallas, Texas, United States, 75230

Cedar Health Research, LLC

Recruiting

Dallas, Texas, United States, 75251

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

David Turbay, MD

Recruiting

El Paso, Texas, United States, 79905

Academy of Diabetes Thyroid and Endocrine

Recruiting

El Paso, Texas, United States, 79935

Biopharma Informatic, LLC

Recruiting

Houston, Texas, United States, 77043

Cardiovascular Specialists of Willowbrook

Recruiting

Houston, Texas, United States, 77070

PlanIt Research, PLLC

Recruiting

Houston, Texas, United States, 77079

Research Physicians Network, LLC

Recruiting

Houston, Texas, United States, 77089

Vital Heart and Vein

Recruiting

Humble, Texas, United States, 77338

Tcr Institute Llc

Recruiting

Kingwood, Texas, United States, 77339

Helium Research Group

Recruiting

Lake Jackson, Texas, United States, 77566

Epic Clinical Research

Recruiting

Lewisville, Texas, United States, 75057

Biopharma Informatic-McAllen

Recruiting

McAllen, Texas, United States, 78503

Southern Endocrinology Associates PA

Recruiting

Mesquite, Texas, United States, 75149

North Hills Medical Research

Recruiting

North Richland Hills, Texas, United States, 76180

Bandera Family Health Care

Recruiting

San Antonio, Texas, United States, 78249

Consano Clinical Research - Shavano Park

Recruiting

Shavano Park, Texas, United States, 78231

Sugar Lakes Family Practice

Recruiting

Sugar Land, Texas, United States, 77479

Wichita Falls Heart Clinic

Recruiting

Wichita Falls, Texas, United States, 76301

Boeson Research

Recruiting

Provo, Utah, United States, 84604

Velocity Clinical Research - Salt Lake City

Recruiting

West Jordan, Utah, United States, 84088

Inova Cardiology - Fairfax

Recruiting

Fairfax, Virginia, United States, 22031

Virginia Heart

Recruiting

Falls Church, Virginia, United States, 22042

VA Puget Sound Healthcare System

Recruiting

Seattle, Washington, United States, 98108

Velocity Clinical Research - Spokane

Recruiting

Spokane, Washington, United States, 99218

Vaught Neurological Services

Recruiting

Crab Orchard, West Virginia, United States, 25827

Aspirus Cardiovascular Associates

Recruiting

Wausau, Wisconsin, United States, 54401

Janek Senaratne Professional Medical Corporation

Recruiting

Edmonton, Alberta, Canada, T6K 4C1

Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Discovery Clinical Services Ltd

Recruiting

Victoria, British Columbia, Canada, V8T 5G4

G A Research Associates Limited

Recruiting

Moncton, New Brunswick, Canada, E1G 1A7

Centricity Research Brampton

Recruiting

Brampton, Ontario, Canada, L6S 0C6

Aggarwal and Associates Ltd

Recruiting

Brampton, Ontario, Canada, L6T 0G1

Cambridge Cardiac Care Centre

Recruiting

Cambridge, Ontario, Canada, N1R 6V6

North York Diagnostic and Cardiac Centre

Recruiting

North York, Ontario, Canada, M6B 3H7

Heart Health Institute Research Incorporated

Recruiting

Scarborough Village, Ontario, Canada, M1B 4Z8

KMH Cardiology Centres Incorporated Hamilton

Recruiting

Stoney Creek, Ontario, Canada, L8J 3W2

Diabetes Heart Research Centre

Recruiting

Toronto, Ontario, Canada, M6G 1M2

Ecogene-21

Recruiting

Chicoutimi, Quebec, Canada, G7H 7K9

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Centre de Recherche du Centre Hospitalier de l Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Institut Universitaire de cardiologie et de pneumologie de Quebec

Recruiting

Québec, Quebec, Canada, G1V 4G5

Centre intégré de santé et service sociaux de Lanaudière

Recruiting

Saint-Charles-Borromée, Quebec, Canada, J6E 6J2

More Information

Sponsor

Amgen

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Atherosclerotic Cardiovascular Disease
  • Overweight
  • Obesity
  • Maridebart cafraglutide
  • AMG 133
  • MariTide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amgen on 2026-09-03.