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RECRUITING Phase 3

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

NCT07037459 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Placebo
  • DRUG Maridebart cafraglutide

Study Locations (20)

California

  • National Heart Institute — Beverly Hills
  • Valley Clinical Trials, LLC dba Flourish Research — Covina
  • National Institute of Clinical Research — Huntington Beach
  • 310 Clinical Research — Inglewood
  • Radin Cardiovascular Medical Group — Newport Beach
  • Valley Clinical Trials — Northridge
  • University of California Irvine — Orange
  • Empire Clinical Research — Pomona
  • San Diego Cardiac Center — San Diego
  • NorthBay Clinical Research LLC — Santa Rosa
  • Manshadi Heart Institute — Stockton

Alabama

  • University of Alabama at Birmingham — Birmingham
  • SEC Clinical Research — Dothan
  • Eastern Shore Research Institute — Fairhope
  • Heart Center Research LLC — Huntsville

Arizona

  • HonorHealth — Phoenix
  • Medical Advancement Centers of Arizona — Phoenix
  • Pima Heart and Vascular Clinical Research — Tucson
  • Yuma Clinical Trials — Yuma

Arkansas

  • Arkansas Cardiology — Little Rock

Trial Details

FieldValue
Enrollment Target 5,056 participants
Start Date 2025-06-25
Est. Completion 2030-09-29
Phase Phase 3

Sponsor

Amgen

266 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07037459

The ClinicalTrials.gov registry entry for NCT07037459 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,056 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07037459 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07037459 about?

NCT07037459 is a clinical study titled "Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity". 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 fract...

What is the current status of trial NCT07037459?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 5,056 participants. The study started on 2025-06-25. Estimated completion is 2030-09-29.

What conditions does trial NCT07037459 study?

This clinical trial studies the following conditions: Obesity, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07037459?

The interventions under investigation include: Placebo (DRUG), Maridebart cafraglutide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07037459?

This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07037459 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial