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Maridebart Cafraglutide for Heart Failure and Obesity

This study is testing if maridebart cafraglutide, given as an injection under the skin, can help people with heart failure (HF) and obesity. It's for those with heart failure where the heart's pumping ability is preserved (HFpEF) or mildly reduced (HFmrEF). Researchers want to see if this drug, when added to usual care, can reduce serious heart events like hospitalizations and improve symptoms. You might be able to join if you are 18 to 99 years old, have a body mass index (BMI) of 30 or higher, and have been diagnosed with heart failure for at least 30 days. The study compares maridebart cafraglutide to a placebo (an inactive substance). The study will be considered successful if fewer participants experience a heart-related death or heart failure events over about 35 months.

Study design
This is a Phase 3, global study with about 5056 participants. It is a double-blind study, meaning neither you nor your doctor will know if you are receiving the study drug or placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 35 months to track heart-related events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07037459

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

Recruiting
PHASE3Ages 18–99InterventionalTreatment
Amgen
~5,056 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Maridebart cafraglutidePlacebo

At a glance

Recruiting sites
624 of 628 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to First Occurrence of a Composite Endpoint Consisting of: CV Death or HF Events
Measured over Up to approximately 35 months

Conditions

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

Explore related trials

Heart FailureObesity

Where it's being run

628 sites across 137 states
Czechia34
Germany31
Hungary27
Poland25
Florida20
Slovakia19
United Kingdom19
France16

Study leadership

  • MD · STUDY_DIRECTOR · Amgen

Who to contact

Amgen Call Center
[email protected]
866-572-6436
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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.
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):
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:
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.

What this trial measures

  • Time to First Occurrence of a Composite Endpoint Consisting of: CV Death or HF EventsUp to approximately 35 months

    Heart Failure events include: hospitalization for HF or urgent HF visits.