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RECRUITING

NCT07037459

PHASE3

Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity

Sponsor: Amgen

View on ClinicalTrials.gov

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.

Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

5056

Start Date

2025-06-25

Completion Date

2030-09-29

Last Updated

2026-10-29

Healthy Volunteers

Conditions

Heart Failure With Preserved Ejection Fraction Heart Failure With Mildly Reduced Ejection Fraction Obesity

Interventions

DRUG

Maridebart cafraglutide

Maridebart cafraglutide will be administered SC.

DRUG

Placebo

Placebo will be administered SC.

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.

Locations (686)

University of Alabama Saint Vincent's Birmingham

Birmingham, Alabama, United States

SEC Clinical Research

Dothan, Alabama, United States

Eastern Shore Research Institute

Fairhope, Alabama, United States

Huntsville Clinical Research, LLC

Huntsville, Alabama, United States

HonorHealth

Phoenix, Arizona, United States

Medical Advancement Centers of Arizona

Phoenix, Arizona, United States

Pima Heart and Vascular Clinical Research

Tucson, Arizona, United States

Yuma Clinical Trials

Yuma, Arizona, United States

Arkansas Cardiology

Little Rock, Arkansas, United States

National Heart Institute

Beverly Hills, California, United States

Valley Clinical Trials, LLC dba Flourish Research

Covina, California, United States

National Institute of Clinical Research

Huntington Beach, California, United States

310 Clinical Research

Inglewood, California, United States

Radin Cardiovascular Medical Group

Newport Beach, California, United States

Valley Clinical Trials

Northridge, California, United States

University of California Irvine

Orange, California, United States

Empire Clinical Research

Pomona, California, United States

San Diego Cardiac Center

San Diego, California, United States

Kaiser Permanente

San Francisco, California, United States

NorthBay Clinical Research LLC

Santa Rosa, California, United States

Manshadi Heart Institute

Stockton, California, United States

Cardiology Associates of Fairfield County PC

Stamford, Connecticut, United States

Orlando Heart and Vascular Institute

Altamonte Springs, Florida, United States

D and H Tamarac Research Center

Aventura, Florida, United States

Excel Medical Clinical Trials

Boca Raton, Florida, United States

South Palm Cardiovascular Associates

Boynton Beach, Florida, United States

Cardiovascular and Vein Center of Florida

Bradenton, Florida, United States

Millennium Medical Research

Coral Gables, Florida, United States

Elite Cardiac Research Center LLC

Hialeah, Florida, United States

Encore Medical Research LLC

Hollywood, Florida, United States

Nature Coast Clinical Research

Inverness, Florida, United States

East Coast Institute for Research

Jacksonville, Florida, United States

First Coast Cardiovascular Institute PA

Jacksonville, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Clearwater Cardiovascular Consultants

Largo, Florida, United States

Ocala Cardiovascular Research

Ocala, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Orlando Health Heart Institute

Orlando, Florida, United States

Ormond Beach Clinical Research

Ormond Beach, Florida, United States

Broward Research Center

Pembroke Pines, Florida, United States

Ascension Sacred Heart

Pensacola, Florida, United States

Cardiovascular Center of Sarasota

Sarasota, Florida, United States

Cardiology Partners Clinical Research Institute

Wellington, Florida, United States

Guardian Research Organization LLC

Winter Park, Florida, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Privia Medical Group Georgia LLC

Peachtree City, Georgia, United States

High Desert Heart and Vascular

Meridian, Idaho, United States

Chicago Medical Research LLC

Hazel Crest, Illinois, United States

Midwest Cardiovascular Research And Education Foundation

Elkhart, Indiana, United States

Ascension Medical Group

Indianapolis, Indiana, United States

Cardiovascular Research of Northwest Indiana LLC

Munster, Indiana, United States

Reid Physician Associates

Richmond, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Johnson County Clintrials

Lenexa, Kansas, United States

Kansas Nephrology Research Institute LLC

Wichita, Kansas, United States

The Research Group of Lexington LLC

Lexington, Kentucky, United States

Our Lady of the Lake Medical Center

Baton Rouge, Louisiana, United States

Louisiana Heart Center - Hammond

Covington, Louisiana, United States

Heart Clinic of Hammond

Hammond, Louisiana, United States

Northshore Heart and Vascular LLC

Mandeville, Louisiana, United States

Ascension Saint Agnes Heart Care

Baltimore, Maryland, United States

Johns Hopkins University

Baltimore, Maryland, United States

Metropolitan Cardiovascular Consultants LLC

Beltsville, Maryland, United States

Flourish Bowie

Bowie, Maryland, United States

University of Michigan Health System, Dominos Farms

Ann Arbor, Michigan, United States

Embassy Research Network

Bloomfield Township, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Healthy Heart Cardiology

Grand Rapids, Michigan, United States

Advanced Cardiology Associates

Rochester Hills, Michigan, United States

Revival Research Institute

Southfield, Michigan, United States

Mankato Clinic

Mankato, Minnesota, United States

Fairview Health Services M Health Fairview St Johns Hospital

Maplewood, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Kalispell Regional Medical Center

Kalispell, Montana, United States

Bryan Heart

Lincoln, Nebraska, United States

Methodist Physicians Clinic Heart Consultants

Omaha, Nebraska, United States

Advanced Heart Care LLC

Bridgewater, New Jersey, United States

Virtua Health Incorporated

Marlton, New Jersey, United States

Saint Michaels Medical Center

Newark, New Jersey, United States

CardioMetabolic Collaborative Clinic

Somerset, New Jersey, United States

Capital Cardiology Associates

Albany, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Hudson Valley Cardiovascular Practice PC

Poughkeepsie, New York, United States

Richmond University Medical Center

Staten Island, New York, United States

Asheville Cardiology Associates

Asheville, North Carolina, United States

Duke University Health System

Durham, North Carolina, United States

Ima Clinical Research - Lenoir

Lenoir, North Carolina, United States

Accellacare of Piedmont Healthcare

Statesville, North Carolina, United States

Accellacare of Wilmington

Wilmington, North Carolina, United States

South Oklahoma Heart Research

Oklahoma City, Oklahoma, United States

Abington Medical Specialists

Horsham, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Monument Health Clinical Research

Rapid City, South Dakota, United States

Apex Research Foundation, LLC

Jackson, Tennessee, United States

The Jackson Clinic PA

Jackson, Tennessee, United States

Parkway Cardiology Associates

Oak Ridge, Tennessee, United States

Cardiovascular Research of Knoxville North Knoxville Medical Center

Powell, Tennessee, United States

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, United States

PharmaTex Research, LLC

Amarillo, Texas, United States

And 586 more locations on ClinicalTrials.gov

Clinical Research Directory

Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (686)