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Clinical Trials in the USA / NCT07037459
Recruiting Phase 3

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

NCT07037459 · tracked via the Priya Life Science USA tracker
Sponsor
Amgen
Phase
Phase 3
Started
2025-06-25
Last updated
2026-09-16

Condition(s) studied

Heart Failure With Preserved Ejection FractionHeart Failure With Mildly Reduced Ejection FractionObesity

Investigational drug(s) / intervention(s)

Maridebart cafraglutidePlacebo

Maridebart cafraglutide: Maridebart cafraglutide will be administered SC.

Placebo: Placebo will be administered SC.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (657)

FacilityCityRegionStatus
University of Alabama Saint Vincent's Birmingham Birmingham Alabama Recruiting
SEC Clinical Research Dothan Alabama Recruiting
Eastern Shore Research Institute Fairhope Alabama Recruiting
Heart Center Research LLC Huntsville Alabama Recruiting
HonorHealth Phoenix Arizona Recruiting
Medical Advancement Centers of Arizona Phoenix Arizona Recruiting
Pima Heart and Vascular Clinical Research Tucson Arizona Recruiting
Yuma Clinical Trials Yuma Arizona Recruiting
Arkansas Cardiology Little Rock Arkansas Recruiting
National Heart Institute Beverly Hills California Recruiting
Valley Clinical Trials, LLC dba Flourish Research Covina California Recruiting
National Institute of Clinical Research Huntington Beach California Recruiting
310 Clinical Research Inglewood California Recruiting
Radin Cardiovascular Medical Group Newport Beach California Recruiting
Valley Clinical Trials Northridge California Recruiting
University of California Irvine Orange California Recruiting
Empire Clinical Research Pomona California Recruiting
San Diego Cardiac Center San Diego California Recruiting
Kaiser Permanente San Francisco California Recruiting
NorthBay Clinical Research LLC Santa Rosa California Recruiting
Manshadi Heart Institute Stockton California Recruiting
Cardiology Associates of Fairfield County PC Stamford Connecticut Recruiting
Orlando Heart and Vascular Institute Altamonte Springs Florida Recruiting
D and H Tamarac Research Center Aventura Florida Recruiting
Excel Medical Clinical Trials Boca Raton Florida Recruiting
Cardiovascular and Vein Center of Florida Bradenton Florida Recruiting
Millennium Medical Research Coral Gables Florida Recruiting
Elite Cardiac Research Center LLC Hialeah Florida Recruiting
Encore Medical Research LLC Hollywood Florida Recruiting
Nature Coast Clinical Research Inverness Florida Recruiting
East Coast Institute for Research Jacksonville Florida Recruiting
First Coast Cardiovascular Institute PA Jacksonville Florida Recruiting
Jacksonville Center for Clinical Research Jacksonville Florida Recruiting
Clearwater Cardiovascular Consultants Largo Florida Recruiting
Ocala Cardiovascular Research Ocala Florida Recruiting
AdventHealth Orlando Orlando Florida Recruiting
Orlando Health Heart Institute Orlando Florida Recruiting
Ormond Beach Clinical Research Ormond Beach Florida Recruiting
Broward Research Center Pembroke Pines Florida Recruiting
Ascension Sacred Heart Pensacola Florida Recruiting

+ 617 more sites — see the full list on the official registry below.

More Amgen trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07037459 on ClinicalTrials.gov ↗ ← All trials in the USA