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

Study acronym: MARITIME-HF
StatusRecruiting
PhasePhase 3
SponsorAmgen
Started

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Record History

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  1. Trial sites expanded: 628 → 657 locations
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 12 of 33 entries
  2. Trial sites expanded: 605 → 628 locations
    • Eligibility criteria shortened, about 62 words
    • Secondary endpoints: 32 to 33
    v30
  3. Study sites: 604 to 605v29
  4. Study sites: 603 to 604v28
  5. Trial sites expanded: 596 → 603 locationsv27
  6. Trial sites expanded: 590 → 596 locationsv26
  7. Trial sites expanded: 586 → 590 locationsv25
  8. Study sites: 584 to 586v24
  9. Trial sites expanded: 564 → 584 locationsv23
  10. Study sites: 562 to 564v22
  11. Study sites: 542 to 562v21
  12. Study sites: 535 to 542v20
  13. Study sites: 528 to 535v19
  14. Study sites: 515 to 528v18
  15. Study sites: 509 to 515v17
  16. Study sites: 505 to 509
    • Eligibility criteria expanded, about 99 words
    • Secondary endpoints: 31 to 32
    v16
  17. Study sites: 504 to 505v15
  18. Study sites: 326 to 504v14
  19. Study sites: 245 to 326v13
  20. Study sites: 199 to 245v12
  21. Study sites: 113 to 199v11
  22. Study sites: 101 to 113v10
  23. Study sites: 93 to 101v9
  24. Study sites: 84 to 93v8
  25. Study sites: 80 to 84v7
  26. Study sites: 51 to 80v6
  27. Study sites: 34 to 51v5
  28. Study sites: 22 to 34v4
  29. Study sites: 7 to 22v3
  30. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 7
    • Start date changed from estimate of Jul 29, 2025 to Jun 25, 2025
    v2
  31. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Amgen
170 trials monitored
See 10 trials at risk
Heart Disease
8,862 trials monitored
See 438 trials at risk
Obesity
3,903 trials monitored
See 160 trials at risk
Heart Failure
2,014 trials monitored
See 120 trials at risk
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.
Trial Details
NCT Number NCT07037459
Lead Sponsor Amgen
Conditions
(from sponsor)		 Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction, Obesity
Related terms Heart Failure, Obesity
Enrollment 5,056 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov