Recruiting
Phase 3

Maridebart

Sponsor:

Amgen

Code:

NCT07037459

Conditions

Heart Failure With Preserved Ejection Fraction

Heart Failure With Mildly Reduced Ejection Fraction

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Maridebart cafraglutide

Placebo

Study Details

Brief summary:

This trial will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.

Conditions

Heart Failure With Preserved Ejection Fraction

Heart Failure With Mildly Reduced Ejection Fraction

Obesity

Study ID

NCT07037459

Start date

Jun 25, 2025

Status verified date

Jun, 2026

Completion date

Sep 29, 2030

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18 years at the time of informed consent.
  • BMI ≥ 30.0 kg/m\^2 at randomization.
  • HF diagnosed for at least 30 days with New York Heart Association (NYHA) Class II-IV at the time of informed consent.
  • Managed with HF standard of care therapies.
  • Left ventricular ejection fraction (LVEF) of > 40% within 12 months before randomization.

Exclusion Criteria:

  • History of any of the following within 60 days prior to or during screening: Type I (spontaneous) MI, valvular replacement or repair, coronary revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke.
  • HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active or chronic myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease.
  • Hospitalized with acute decompensated HF at the time of or during the screening period.
  • Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes.
  • For participants with a prior diagnosis of T2DM (including those diagnosed during screening):

1. HbA1c > 10.0% (86 mmol/mol) at screening
2. Uncontrolled diabetes requiring immediate therapy
3. History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization
4. One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness
5. History or presence of either proliferative diabetic retinopathy, or diabetic maculopathy, or severe non-proliferative diabetic retinopathy; or currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
  • SBP ≥ 180 mmHg during the screening period, or on three or more blood pressure-lowering drugs with a SBP > 160 mmHg during the screening period (including day 1 prior to randomization).
  • History of chronic pancreatitis or acute pancreatitis in the 180 days before screening or during the screening period.
  • Any personal lifetime history of, or family history(first-degree relative\[s\]) of medullary thyroid carcinoma or MEN-2.
  • eGFR < 20 mL/min/1.73 m\^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening.
  • Calcitonin ≥ 50 ng/L (pg/mL) at screening.
  • Acute or chronic hepatitis.
  • Any of the following psychiatric history:

1. History of unstable major depressive disorder or other severe psychiatric disorder within 2 years prior to screening or during the screening period
2. Lifetime history of suicide attempt
3. History of non-suicidal self-injury within 5 years prior to screening or during the screening period.
  • History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the trial.
  • 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 prior to or during the screening period or planned use during the conduct of the trial.

Study Design

Enrollment

5056 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 or HF Events [ Time Frame: Up to approximately 35 months ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

University of Alabama Saint Vincent's Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

SEC Clinical Research

Recruiting

Dothan, Alabama, United States, 36305

Eastern Shore Research Institute

Recruiting

Fairhope, Alabama, United States, 36532

Heart Center Research LLC

Recruiting

Huntsville, Alabama, United States, 35801-4317

HonorHealth

Recruiting

Phoenix, Arizona, United States, 85006

Medical Advancement Centers of Arizona

Recruiting

Phoenix, Arizona, United States, 85044

Pima Heart and Vascular Clinical Research

Recruiting

Tucson, Arizona, United States, 85704

Yuma Clinical Trials

Recruiting

Yuma, Arizona, United States, 85365

Arkansas Cardiology

Recruiting

Little Rock, Arkansas, United States, 72205

National Heart Institute

Recruiting

Beverly Hills, California, United States, 90211

Valley Clinical Trials, LLC dba Flourish Research

Recruiting

Covina, California, United States, 91723

National Institute of Clinical Research

Recruiting

Huntington Beach, California, United States, 92648

310 Clinical Research

Recruiting

Inglewood, California, United States, 90301

Radin Cardiovascular Medical Group

Recruiting

Newport Beach, California, United States, 92663

Valley Clinical Trials

Recruiting

Northridge, California, United States, 91325

University of California Irvine

Recruiting

Orange, California, United States, 92868

Empire Clinical Research

Recruiting

Pomona, California, United States, 91767

San Diego Cardiac Center

Recruiting

San Diego, California, United States, 92123

NorthBay Clinical Research LLC

Recruiting

Santa Rosa, California, United States, 95405

Manshadi Heart Institute

Recruiting

Stockton, California, United States, 95204

Cardiology Associates of Fairfield County PC

Recruiting

Stamford, Connecticut, United States, 06905

Orlando Heart and Vascular Institute

Recruiting

Altamonte Springs, Florida, United States, 32714

D and H Tamarac Research Center

Recruiting

Aventura, Florida, United States, 33180

Excel Medical Clinical Trials

Recruiting

Boca Raton, Florida, United States, 33434

Cardiovascular and Vein Center of Florida

Recruiting

Bradenton, Florida, United States, 34209

Millennium Medical Research

Recruiting

Coral Gables, Florida, United States, 33134

Elite Cardiac Research Center LLC

Recruiting

Hialeah, Florida, United States, 33013

Encore Medical Research LLC

Recruiting

Hollywood, Florida, United States, 33024

Nature Coast Clinical Research

Recruiting

Inverness, Florida, United States, 34452

East Coast Institute for Research

Recruiting

Jacksonville, Florida, United States, 32216

First Coast Cardiovascular Institute PA

Recruiting

Jacksonville, Florida, United States, 32216

Jacksonville Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32216

Clearwater Cardiovascular Consultants

Recruiting

Largo, Florida, United States, 33777

Ocala Cardiovascular Research

Recruiting

Ocala, Florida, United States, 34471

Orlando Health Heart Institute

Recruiting

Orlando, Florida, United States, 32806

Ormond Beach Clinical Research

Recruiting

Ormond Beach, Florida, United States, 32174

Broward Research Center

Recruiting

Pembroke Pines, Florida, United States, 33024

Ascension Sacred Heart

Recruiting

Pensacola, Florida, United States, 32504

Cardiovascular Center of Sarasota

Recruiting

Sarasota, Florida, United States, 34239

Cardiology Partners Clinical Research Institute

Recruiting

Wellington, Florida, United States, 33449

Guardian Research Organization LLC

Recruiting

Winter Park, Florida, United States, 32792

Privia Medical Group Georgia LLC

Recruiting

Peachtree City, Georgia, United States, 30269

High Desert Heart and Vascular

Recruiting

Meridian, Idaho, United States, 83642

Chicago Medical Research LLC

Recruiting

Hazel Crest, Illinois, United States, 60429

Midwest Cardiovascular Research And Education Foundation

Recruiting

Elkhart, Indiana, United States, 46514

Ascension Medical Group

Recruiting

Indianapolis, Indiana, United States, 46260

Cardiovascular Research of Northwest Indiana LLC

Recruiting

Munster, Indiana, United States, 46321

Reid Physician Associates

Recruiting

Richmond, Indiana, United States, 47374

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Johnson County Clintrials

Recruiting

Lenexa, Kansas, United States, 66219

Kansas Nephrology Research Institute LLC

Recruiting

Wichita, Kansas, United States, 67214

The Research Group of Lexington LLC

Recruiting

Lexington, Kentucky, United States, 40503

Our Lady of the Lake Medical Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Louisiana Heart Center - Hammond

Recruiting

Covington, Louisiana, United States, 70433

Heart Clinic of Hammond

Recruiting

Hammond, Louisiana, United States, 70403

Northshore Heart and Vascular LLC

Recruiting

Mandeville, Louisiana, United States, 70448

Ascension Saint Agnes Heart Care

Recruiting

Baltimore, Maryland, United States, 21229

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Metropolitan Cardiovascular Consultants LLC

Recruiting

Beltsville, Maryland, United States, 20705

Flourish Bowie

Recruiting

Bowie, Maryland, United States, 20715

University of Michigan Health System, Dominos Farms

Recruiting

Ann Arbor, Michigan, United States, 48109-5853

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Healthy Heart Cardiology

Recruiting

Grand Rapids, Michigan, United States, 49546

Advanced Cardiology Associates

Recruiting

Rochester Hills, Michigan, United States, 48307

Mankato Clinic

Recruiting

Mankato, Minnesota, United States, 56001

Fairview Health Services M Health Fairview St Johns Hospital

Recruiting

Maplewood, Minnesota, United States, 55109

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Saint Luke's Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

Kalispell Regional Medical Center

Recruiting

Kalispell, Montana, United States, 59901

Bryan Heart

Recruiting

Lincoln, Nebraska, United States, 68506

Advanced Heart Care LLC

Recruiting

Bridgewater, New Jersey, United States, 08807

Virtua Health Incorporated

Recruiting

Marlton, New Jersey, United States, 08053

Saint Michaels Medical Center

Recruiting

Newark, New Jersey, United States, 07102

CardioMetabolic Collaborative Clinic

Recruiting

Somerset, New Jersey, United States, 08873

Capital Cardiology Associates

Recruiting

Albany, New York, United States, 12211

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10019

Hudson Valley Cardiovascular Practice PC

Recruiting

Poughkeepsie, New York, United States, 12601

Richmond University Medical Center

Recruiting

Staten Island, New York, United States, 10310

Duke University Health System

Recruiting

Durham, North Carolina, United States, 27719

Accellacare of Piedmont Healthcare

Recruiting

Statesville, North Carolina, United States, 28625

Accellacare of Wilmington

Recruiting

Wilmington, North Carolina, United States, 28401

South Oklahoma Heart Research

Recruiting

Oklahoma City, Oklahoma, United States, 73135

Abington Medical Specialists

Recruiting

Horsham, Pennsylvania, United States, 19044

Monument Health Clinical Research

Recruiting

Rapid City, South Dakota, United States, 57701

Apex Research Foundation, LLC

Recruiting

Jackson, Tennessee, United States, 38301

The Jackson Clinic PA

Recruiting

Jackson, Tennessee, United States, 38305

Parkway Cardiology Associates

Recruiting

Oak Ridge, Tennessee, United States, 37830

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

Javara Research

Recruiting

Conroe, Texas, United States, 77384

Dallas Heart and Vascular Consultants

Recruiting

Duncanville, Texas, United States, 75137

David Turbay, MD

Recruiting

El Paso, Texas, United States, 79905

East Texas Cardiology PA

Recruiting

Houston, Texas, United States, 77002

Biopharma Informatic

Recruiting

Houston, Texas, United States, 77025

Biopharma Informatic, LLC

Recruiting

Houston, Texas, United States, 77043

Biopharma Informatic

Recruiting

Houston, Texas, United States, 77084

Vital Heart and Vein

Recruiting

Humble, Texas, United States, 77338

North Dallas Research Associates

Recruiting

McKinney, Texas, United States, 75069

Texas Institute of Cardiology

Recruiting

McKinney, Texas, United States, 75071

Sherman Clinical Research

Recruiting

Sherman, Texas, United States, 75092

Northwest Houston Clinical Research PLLC

Recruiting

Tomball, Texas, United States, 77375

Conquest Research, LLC

Recruiting

Arlington, Virginia, United States, 22205

Virginia Heart

Recruiting

Falls Church, Virginia, United States, 22042

Carient Heart and Vascular

Recruiting

Manassas, Virginia, United States, 20109

Roanoke Heart Institute PLC

Recruiting

Roanoke, Virginia, United States, 24014

Salem VA Medical Center

Recruiting

Salem, Virginia, United States, 24153

Pulse Heart Institute

Recruiting

Puyallup, Washington, United States, 98372

Advocate Aurora Saint Lukes Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53215

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

St Boniface Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Cardio 1

Recruiting

Winnipeg, Manitoba, Canada, R3L 1Z5

Brampton Clinical Trials

Recruiting

Brampton, Ontario, Canada, L6Z 4N5

Cambridge Cardiac Care Centre

Recruiting

Cambridge, Ontario, Canada, N1R 6V6

Saul Vizel Professional Medicine Corporation - Vizel Cardiac Research

Recruiting

Cambridge, Ontario, Canada, N1R 7R1

Partners in Advanced Cardiac Evaluation

Recruiting

Newmarket, Ontario, Canada, L3Y 2P6

North York Diagnostic and Cardiac Centre

Recruiting

North York, Ontario, Canada, M6B 3H7

Kawartha Cardiology Clinical Trials

Recruiting

Peterborough, Ontario, Canada, K9J 0B2

CardioQuest Research Centre

Recruiting

Sarnia, Ontario, Canada, N7T 4P5

Heart Health Institute Research Incorporated

Recruiting

Scarborough Village, Ontario, Canada, M1B 4Z8

KMH Cardiology Centres Incorporated Hamilton

Recruiting

Stoney Creek, Ontario, Canada, L8J 3W2

Curans Heart Center

Recruiting

Thunder Bay, Ontario, Canada, P7B 5N3

Womens College Hospital

Recruiting

Toronto, Ontario, Canada, M5S 1B2

Diabetes Heart Research Centre

Recruiting

Toronto, Ontario, Canada, M6G 1M2

CPS Research

Recruiting

Waterloo, Ontario, Canada, N2T 0C1

Winchester District Memorial Hospital

Recruiting

Winchester, Ontario, Canada, K0C 2K0

Ecogene-21

Recruiting

Chicoutimi, Quebec, Canada, G7H 7K9

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Diex Recherche Sherbrooke Est

Recruiting

Sherbrooke, Quebec, Canada, J1E 0N8

Diex Recherche Trois Rivieres

Recruiting

Trois-Rivières, Quebec, Canada, G9A 4P3

More Information

Sponsor

Amgen

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • Heart Failure
  • Obesity
  • Maridebart Cafraglutide
  • AMG 133
  • MariTide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Amgen on 2026-07-02.