NCT07037459 · Amgen
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
(MARITIME-HF)
What this study is about
This study will examine if maridebart cafraglutide as an adjunct to the usual treatment 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.
View original scientific description
This study 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 study with a double-blind period and an open-label extension (OLE).
Interventions
DRUG
Maridebart cafraglutide
Maridebart cafraglutide will be administered SC.
DRUG
Placebo
Placebo will be administered SC.
Primary outcome measures
Time to First Occurrence of a Composite Endpoint Consisting of: CV Death or HF Events
Time frame: Up to approximately 35 months
Heart Failure events include: hospitalization for HF or urgent HF visits.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥ 18 years.
- BMI ≥ 30 kg/m\^2.
- HF diagnosed for at least 30 days before screening with New York Heart Association (NYHA) Class II-IV.
- Managed with HF standard of care therapies.
- Left ventricular ejection fraction (LVEF) of \> 40%.
- Elevated NT-proBNP.
- Participants must have at least one of the following: 1. Structural heart disease OR 2. Documented hospitalization with a primary diagnosis of decompensated HF within 12 months before randomization OR 3. Evidence of elevated filling pressures within 12 months before randomization.
Exclusion criteria
- History of any of the following within 60 days before 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 ventri
Where
- Birmingham, Alabama
- Dothan, Alabama
- Fairhope, Alabama
- Huntsville, Alabama
- Phoenix, Arizona
- Tucson, Arizona
- Yuma, Arizona
- Little Rock, Arkansas
- Beverly Hills, California
- Covina, California
- Huntington Beach, California
- Inglewood, California
And 90 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations