Home › Trials › NCT07037459

Maridebart cafraglutide for people with obesity and preserved or mildly reduced ejection fraction heart failure

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)

Phase 3 Interventional Amgen · NCT07037459

This trial will test whether adding maridebart cafraglutide to usual heart-failure care can reduce hospital visits, cardiovascular deaths, and improve symptoms in adults with obesity and HFpEF or HFmrEF.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment5056 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorAmgen Industry-sponsored
Locations603 sites (Birmingham, Alabama and 602 other locations)
Trial IDNCT07037459 on ClinicalTrials.gov

What this trial studies

This is a global, phase 3, randomized, double-blind, placebo-controlled, 2-part trial with an open-label extension that enrolls adults with obesity and heart failure with preserved or mildly reduced ejection fraction. Participants are randomized to maridebart cafraglutide or placebo on top of standard-of-care therapies, and the trial is event-driven with Part 1 ending after about 850 primary endpoint events. Key outcomes include heart-failure hospitalizations and urgent heart-failure visits, cardiovascular death, and changes in heart-failure symptoms. Eligibility requires obesity (BMI ≥30), elevated NT-proBNP, LVEF >40%, and evidence of structural heart disease, recent decompensation, or elevated filling pressures.

Who should consider this trial

Good fit: Adults aged 18 or older with BMI ≥30 kg/m2, a diagnosis of HFpEF or HFmrEF (LVEF >40%), elevated NT-proBNP, NYHA II–IV symptoms, and evidence of structural heart disease, recent HF hospitalization, or elevated filling pressures who are on standard heart-failure therapy are ideal candidates.

Not a fit: People with reduced ejection fraction (LVEF ≤40%), BMI below 30, recent major cardiac events or procedures that exclude them per protocol, or without elevated NT-proBNP or HF structural/elevated pressure evidence are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the drug could lower heart-failure hospitalizations and cardiovascular deaths and improve symptoms for people with obesity and HFpEF or HFmrEF.

How similar studies have performed: Weight-loss agents in the GLP-1/GIP class have produced substantial weight reduction and some cardiovascular risk benefits, but large event-driven trials specifically testing this approach in obese patients with HFpEF/HFmrEF remain limited, making this a relatively novel outcome trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age ≥ 18 years at the time of informed consent.
* BMI ≥ 30.0 kg/m\^2 at the time of 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 from the beginning of screening.
* Elevated NT-proBNP.
* Participants must have at least one of the following:

  1. Structural heart disease within 12 months prior to screening OR
  2. Documented hospitalization with a primary diagnosis of decompensated HF which required IV loop diuretic treatment \> 30 days and \< 12 months prior to randomization OR
  3. Evidence of elevated filling pressures 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 myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease.
* Any lifetime history of LVEF ≤ 40%.
* 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.
* 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.

Where this trial is running

Birmingham, Alabama and 602 other locations

+553 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart Failure With Preserved Ejection FractionHeart Failure With Mildly Reduced Ejection FractionObesityHeart FailureMaridebart CafraglutideAMG 133MariTide
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.