Maridebart Cafraglutide for Heart Failure

(MARITIME-HF Trial)

Recruiting at 323 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must be taking: Standard HF therapies

Must not be taking: GLP-1 RAs, GIP agonists

Disqualifiers: Type 1 diabetes, Severe psychiatric, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

5056 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called maridebart cafraglutide to determine if it can reduce heart failure events, such as hospital visits and heart-related deaths, in individuals with specific types of heart failure and obesity. The trial compares the effects of the treatment against a placebo (a substance with no active medicine) to assess improvement in heart failure symptoms. It is suitable for individuals who have been dealing with heart failure for at least 30 days, have a BMI over 30, and are currently on heart failure treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants access to a potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you cannot use certain diabetes medications like GLP-1 receptor agonists within 90 days before joining. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that maridebart cafraglutide is likely to be safe for humans?

A previous study showed that maridebart cafraglutide helped people lose weight effectively over 52 weeks without reaching a plateau, suggesting it might be safe for longer use. The treatment is now in a phase 3 trial, indicating it has already passed earlier safety tests in humans. So far, it appears generally well-tolerated, but like any medication, side effects may occur. Discuss with a doctor to determine if joining a trial is appropriate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for heart failure?

Unlike the standard of care for heart failure, which often involves medications like beta-blockers and ACE inhibitors, Maridebart Cafraglutide offers a fresh approach. This treatment is unique because it is administered subcutaneously, which can improve patient compliance compared to oral medications. Additionally, it may work through a new mechanism of action that differs from existing drugs, potentially offering benefits in patients who don't respond well to current therapies. Researchers are excited about its potential to bring a novel option to those living with heart failure.

What evidence suggests that maridebart cafraglutide might be an effective treatment for heart failure?

Research has shown that maridebart cafraglutide, which participants in this trial may receive, might help reduce heart failure events in people who are obese. In earlier studies, this treatment showed promise in managing heart failure by possibly reducing the number of heart-related hospital visits and deaths. Maridebart cafraglutide affects specific pathways related to heart health, potentially improving heart function and symptoms over time. Early findings suggest it could lead to better outcomes for those with heart failure, especially in patients whose hearts pump normally or only slightly less than normal. While more data is needed, these initial results are encouraging for those dealing with heart failure. ^{1 2 5 6 7}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for obese individuals with heart failure who still have normal or slightly reduced heart pumping function. Participants must be stable on standard heart failure treatments and willing to add a new medication or placebo.

Inclusion Criteria

I have been diagnosed with heart failure for at least 30 days and it affects my daily activities.

I am being treated with standard heart failure medications.

My BMI is 30 or higher.

Exclusion Criteria

My blood pressure is very high or I'm on 3+ meds for it.

My kidney function is very low or I am on dialysis.

Any lifetime history of LVEF ≤ 40%

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive maridebart cafraglutide or placebo subcutaneously in a double-blind manner

Up to approximately 35 months

Open-label Extension

Participants may opt into continuation of treatment with maridebart cafraglutide long-term

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Maridebart Cafraglutide

Trial Overview The study tests if adding Maridebart cafraglutide to usual care can reduce hospital visits, improve symptoms, and prevent deaths from heart issues in patients with certain types of heart failure compared to a placebo.

How Is the Trial Designed?

Group I: Maridebart Cafraglutide Experimental Treatment 1 Intervention

Participants will receive maridebart cafraglutide subcutaneously (SC)

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo SC

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07037459

NCT07037459 | Maridebart Cafraglutide in Heart Failure ... This study will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07037433

Study Details | NCT07037433 | Evaluating the Impact of ... ... Heart Failure (HF) Event (5-point MACE), Up to approximately 35 months. Secondary Outcome Measures. Outcome Measure, Measure Description, Time Frame. Time to ...

3. trial.medpath.com trial.medpath.com/clinical-trial/6748ad5869013a35/nct07037459-maridebart-cafraglutide-heart-failure-obesity

Maridebart Cafraglutide in Heart Failure With Preserved or ... 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 ...

4. amgen.com amgen.com/newsroom/press-releases/2025/06/results-from-amgens-phase-2-obesity-study-of-monthly-maritide-presented-at-the-american-diabetes-association-85th-scientific-sessions

RESULTS FROM AMGEN'S PHASE 2 OBESITY STUDY ... Amgen also expects to initiate Phase 3 clinical outcomes studies for atherosclerotic cardiovascular disease (ASCVD) and heart failure (HF), as ...

5. nationalheartinstitute.org nationalheartinstitute.org/clinical-trials/heart-failure/maridebart-cafraglutide-mari-tide-trial-for-obesity-and-heart-failure

Maridebart Cafraglutide (MariTide) Clinical Trial Quantcast. Are You A Candidate? Heart Failure. Maridebart Cafraglutide ... effective and safe MariTide is in reducing heart failure complications and ...

6. ucihealth.org ucihealth.org/clinical-trials/CCR-24-187

Maridebart Cafraglutide in Heart Failure With Preserved or ... Age greater than or equal to 18 years. BMI greater than or equal to 30 kg/m^2. HF diagnosed for at least 30 days before screening with New ...

7. humanforschung-schweiz.ch humanforschung-schweiz.ch/de/studiensuche/studien-detail/67117/translate/en/?cHash=4903d91c360db7865bdde95674709434

A randomized, double-blind, placebo-controlled Phase III ... A randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of Maridebart Cafraglutide regarding ...