ESTIMATED50% CONFIDENCEClinicalTrials.gov[1] lists 2028-06-30 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
- Start
- Jun 30, 202850% CONFIDENCEfrom the source
Maridebart Cafraglutide's Phase 3 Trial in Heart Failure With Preserved Ejection Fraction Reads Out
Amgen's phase 3 trial of Maridebart Cafraglutide in heart failure with preserved ejection fraction reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 5,056 participants. 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.
- NCT07037459 is Amgen's Phase 3 MARITIME-HF trial, a randomized, double-blind, placebo-controlled study of maridebart cafraglutide on mortality and morbidity in people living with heart failure with preserved or mildly reduced ejection fraction (HFpEF and HFmrEF) and obesity[1]
- It examines whether the drug, as an adjunct to standard of care, reduces heart failure events such as HF hospitalizations and urgent HF visits and cardiovascular deaths, and improves HF symptoms; maridebart cafraglutide and placebo are both given subcutaneously[1]
- "This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE)"; it is event-driven, and "Part 1 will conclude when approximately 850 primary endpoint events have occurred"[1]
- Estimated enrollment is 5,056 participants across 657 sites in 34 countries including the United States, China, Japan, Brazil, Germany and the United Kingdom; the record's status is RECRUITING[1]
- The trial started 2025-06-25 (actual), with primary completion estimated at 2028-06-30 and full completion at 2030-09-29; it was first posted 2025-06-25 and last updated 2026-09-16[1]
- The primary outcome is time to first occurrence of a composite endpoint of CV death or HF events, up to approximately 35 months[1]
References 150% CONFIDENCE
The first entry is always the pin's source. Overall confidence is a weighted average of how firmly each reference supports the start and end times used above; a reference counts half as much for every 180 days older than the newest.
- [1]50%clinicaltrials.gov/study/NCT07037459clinicaltrials.gov· Posted Sep 20, 2026· Starts Jun 30, 2028 ✓· 100% of score
ClinicalTrials.gov lists 2028-06-30 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
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