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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Maridebart cafraglutide — DRUG
  Maridebart cafraglutide will be administered SC.
• Placebo — DRUG
  Placebo will be administered SC.

Study Details

This trial 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 trial with a double-blind period and an open-label extension (OLE). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.

Key Dates

Start date

Jun 25, 2025

Status verified

May 2026

Primary completion

Jun 30, 2028

Completion

Sep 29, 2030

Study Design

Enrollment

5,056 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Maridebart Cafraglutide
  Participants will receive maridebart cafraglutide subcutaneously (SC)
• Placebo Comparator: Placebo
  Participants will receive placebo SC

Primary Outcome Measure

Time to First Occurrence of a Composite Endpoint Consisting of: CV Death or HF Events [ Time Frame: Up to approximately 35 months ]

Central Contacts

• Amgen Call Center
  866-572-6436
  [email protected]

Locations (106)

Find similar trials in Birmingham, AL

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