Maridebart Cafraglutide for Heart Failure

(MARITIME-HF Trial)

Recruiting at 243 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 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). The study is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.

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