Tests maridebart cafraglutide in heart failure and obesity
Tests a drug added to usual care in adults with heart failure and obesity.
Plain-language title generated from the registry record
Registry title: Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Key facts
- Where
- Albany, Altamonte Springs, Amarillo, Ann Arbor, Arlington, Asheville, Atlanta, Austin, Aventura, Baltimore, Baton Rouge, Beltsville, Beverly Hills, Birmingham, Bloomfield Township, Boca Raton, Bowie, Boynton Beach, Bradenton, Bridgewater, Conroe, Coral Gables, Covina, Covington, Dallas, Detroit, Dothan, Duncanville, Durham, El Paso, Elkhart, Fairhope, Falls Church, Grand Rapids, Hammond, Hazel Crest, Hialeah, Hollywood, Horsham, Houston, Humble, Huntington Beach, Huntsville, Indianapolis, Inglewood, Inverness, Jackson, Jacksonville, Kalispell, Kansas City, Largo, Lenexa, Lenoir, Lexington, Lincoln, Little Rock, Manassas, Mandeville, Mankato, Maplewood, Marlton, McKinney, Meridian, Milwaukee, Minneapolis, Munster, New York, Newark, Newport Beach, Northridge, Oak Ridge, Ocala, Oklahoma City, Omaha, Orange, Orlando, Ormond Beach, Peachtree City, Pembroke Pines, Pensacola, Phoenix, Pittsburgh, Plano, Pomona, Poughkeepsie, Powell, Puyallup, Rapid City, Richmond, Roanoke, Rochester Hills, Salem, San Diego, San Francisco, Santa Rosa, Sarasota, Sherman, Somerset, Southfield, Stamford, Staten Island, Statesville, Stockton, Tomball, Tucson, Tullahoma, Wellington, Wichita, Wilmington, Winter Park, and Yuma, United StatesSee the 122 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT07037459, who can take part
Where in United States
- Capital Cardiology AssociatesAlbany, United StatesTaking people
- Orlando Heart and Vascular InstituteAltamonte Springs, United StatesTaking people
- PharmaTex Research, LLCAmarillo, United StatesTaking people
- University of Michigan Health System, Dominos FarmsAnn Arbor, United StatesTaking people
- Conquest Research, LLCArlington, United StatesTaking people
- Asheville Cardiology AssociatesAsheville, United StatesTaking people
- Piedmont Heart InstituteAtlanta, United StatesTaking people
- Austin HeartAustin, United StatesTaking people
- D and H Tamarac Research CenterAventura, United StatesTaking people
- Ascension Saint Agnes Heart CareBaltimore, United StatesTaking people
- Johns Hopkins UniversityBaltimore, United StatesTaking people
- Our Lady of the Lake Medical CenterBaton Rouge, United StatesNo longer taking part
- Metropolitan Cardiovascular Consultants LlcBeltsville, United StatesTaking people
- National Heart InstituteBeverly Hills, United StatesTaking people
- University of Alabama Saint Vincent's BirminghamBirmingham, United StatesTaking people
- Embassy Research NetworkBloomfield Township, United StatesTaking people
- Excel Medical Clinical TrialsBoca Raton, United StatesTaking people
- Flourish BowieBowie, United StatesTaking people
- South Palm Cardiovascular AssociatesBoynton Beach, United StatesTaking people
- Cardiovascular and Vein Center of FloridaBradenton, United StatesNo longer taking part
- Advanced Heart Care LLCBridgewater, United StatesNo longer taking part
- Javara ResearchConroe, United StatesTaking people
- Millennium Medical ResearchCoral Gables, United StatesTaking people
- Valley Clinical Trials, LLC dba Flourish ResearchCovina, United StatesTaking people
- Louisiana Heart Center - HammondCovington, United StatesTaking people
- Cedar Health Research, LLCDallas, United StatesTaking people
- Henry Ford Health SystemDetroit, United StatesTaking people
- SEC Clinical ResearchDothan, United StatesTaking people
- Dallas Heart and Vascular ConsultantsDuncanville, United StatesTaking people
- Duke University Health SystemDurham, United StatesTaking people
- David Turbay, MDEl Paso, United StatesTaking people
- Midwest Cardiovascular Research and Education FoundationElkhart, United StatesTaking people
- Eastern Shore Research InstituteFairhope, United StatesTaking people
- Virginia HeartFalls Church, United StatesTaking people
- Healthy Heart CardiologyGrand Rapids, United StatesTaking people
- Heart Clinic of HammondHammond, United StatesTaking people
- Chicago Medical Research LLCHazel Crest, United StatesTaking people
- Elite Cardiac Research Center LLCHialeah, United StatesTaking people
- Encore Medical Research LLCHollywood, United StatesTaking people
- Abington Medical SpecialistsHorsham, United StatesTaking people
- Biopharma InformaticHouston, United StatesTaking people
- Biopharma Informatic, LLCHouston, United StatesTaking people
- East Texas Cardiology PAHouston, United StatesTaking people
- Orion MedicalHouston, United StatesTaking people
- Vital Heart and VeinHumble, United StatesTaking people
- National Institute of Clinical ResearchHuntington Beach, United StatesTaking people
- Huntsville Clinical Research, LLCHuntsville, United StatesTaking people
- Ascension Medical GroupIndianapolis, United StatesTaking people
- 310 Clinical ResearchInglewood, United StatesTaking people
- Nature Coast Clinical ResearchInverness, United StatesTaking people
- Apex Research Foundation, LLCJackson, United StatesTaking people
- The Jackson Clinic, PAJackson, United StatesTaking people
- East Coast Institute for ResearchJacksonville, United StatesTaking people
- First Coast Cardiovascular Institute PAJacksonville, United StatesTaking people
- Jacksonville Center for Clinical ResearchJacksonville, United StatesTaking people
- Kalispell Regional Medical CenterKalispell, United StatesTaking people
- Saint Luke's Hospital of Kansas CityKansas City, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesTaking people
- Clearwater Cardiovascular ConsultantsLargo, United StatesTaking people
- Johnson County ClintrialsLenexa, United StatesTaking people
- IMA Clinical Research - LenoirLenoir, United StatesTaking people
- The Research Group of Lexington LLCLexington, United StatesTaking people
- Bryan HeartLincoln, United StatesTaking people
- Arkansas CardiologyLittle Rock, United StatesTaking people
- Carient Heart and VascularManassas, United StatesTaking people
- Northshore Heart and Vascular LLCMandeville, United StatesTaking people
- Mankato ClinicMankato, United StatesTaking people
- Fairview Health Services M Health Fairview St Johns HospitalMaplewood, United StatesTaking people
- Virtua Health IncorporatedMarlton, United StatesNo longer taking part
- North Dallas Research AssociatesMcKinney, United StatesTaking people
- Texas Institute of CardiologyMcKinney, United StatesTaking people
- High Desert Heart and VascularMeridian, United StatesTaking people
- Advocate Aurora Saint Lukes Medical CenterMilwaukee, United StatesTaking people
- University of MinnesotaMinneapolis, United StatesTaking people
- Cardiovascular Research of Northwest Indiana, LLCMunster, United StatesTaking people
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- Saint Michaels Medical CenterNewark, United StatesTaking people
- Radin Cardiovascular Medical GroupNewport Beach, United StatesTaking people
- Valley Clinical TrialsNorthridge, United StatesTaking people
- Parkway Cardiology AssociatesOak Ridge, United StatesTaking people
- Ocala Cardiovascular ResearchOcala, United StatesTaking people
- South Oklahoma Heart ResearchOklahoma City, United StatesTaking people
- Methodist Physicians Clinic Heart ConsultantsOmaha, United StatesNo longer taking part
- University of California IrvineOrange, United StatesTaking people
- AdventHealth OrlandoOrlando, United StatesTaking people
- Orlando Health Heart InstituteOrlando, United StatesTaking people
- Ormond Beach Clinical ResearchOrmond Beach, United StatesTaking people
- Privia Medical Group Georgia LLCPeachtree City, United StatesTaking people
- Broward Research CenterPembroke Pines, United StatesTaking people
- Ascension Sacred HeartPensacola, United StatesTaking people
- Medical Advancement Centers of ArizonaPhoenix, United StatesTaking people
- HonorHealthPhoenix, United StatesNo longer taking part
- University of Pittsburgh Medical CenterPittsburgh, United StatesTaking people
- Stryde Research - Pioneer Primary Care and Cardiology ClinicPlano, United StatesTaking people
- Empire Clinical ResearchPomona, United StatesTaking people
- Hudson Valley Cardiovascular Practice PCPoughkeepsie, United StatesTaking people
- Cardiovascular Research of Knoxville North Knoxville Medical CenterPowell, United StatesTaking people
- Pulse Heart InstitutePuyallup, United StatesTaking people
- Monument Health Clinical ResearchRapid City, United StatesTaking people
- Reid Physician AssociatesRichmond, United StatesTaking people
- Roanoke Heart Institute PLCRoanoke, United StatesTaking people
- Advanced Cardiology AssociatesRochester Hills, United StatesTaking people
- Salem VA Medical CenterSalem, United StatesTaking people
- San Diego Cardiac CenterSan Diego, United StatesTaking people
- Kaiser PermanenteSan Francisco, United StatesTaking people
- NorthBay Clinical Research LLCSanta Rosa, United StatesTaking people
- Cardiovascular Center of SarasotaSarasota, United StatesTaking people
- Sherman Clinical ResearchSherman, United StatesTaking people
- CardioMetabolic Collaborative ClinicSomerset, United StatesTaking people
- Revival Research InstituteSouthfield, United StatesTaking people
- Cardiology Associates of Fairfield County PCStamford, United StatesTaking people
- Richmond University Medical CenterStaten Island, United StatesTaking people
- Accellacare of Piedmont HealthCareStatesville, United StatesTaking people
- Manshadi Heart InstituteStockton, United StatesTaking people
- Northwest Houston Clinical Research PLLCTomball, United StatesTaking people
- Pima Heart and Vascular Clinical ResearchTucson, United StatesTaking people
- Tennessee Center for Clinical TrialsTullahoma, United StatesTaking people
- Cardiology Partners Clinical Research InstituteWellington, United StatesTaking people
- Kansas Nephrology Research Institute LLCWichita, United StatesNo longer taking part
- Accellacare of WilmingtonWilmington, United StatesTaking people
- Guardian Research Organization LLCWinter Park, United StatesTaking people
- Yuma Clinical TrialsYuma, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amgen
- Trial code
- NCT07037459
- Record updated
- 29 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; 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 of the following psychiatric history:; History of unstable major depressive disorder or other severe psychiatric disorder within 2 years prior to screening or during the screening period; Lifetime history of suicide attempt; History of non-suicidal self-injury within 5 years prior to screening or during the screening period; 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; Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes; Any personal lifetime history of, or family history(first-degree relative[s]) of medullary thyroid carcinoma or MEN-2; Acute or chronic hepatitis; History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the trial; For participants with a prior diagnosis of T2DM (including those diagnosed during screening):; HbA1c > 10.0% (86 mmol/mol) at screening; Uncontrolled diabetes requiring immediate therapy; 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 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; eGFR < 20 mL/min/1.73 m\^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening; 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; Hospitalized with acute decompensated HF at the time of or during the screening period; Calcitonin ≥ 50 ng/L (pg/mL) at screening.