Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

Study acronym: MARITIME-OSA-1
StatusActive, Not Recruiting
PhasePhase 3
SponsorAmgen
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary completion date: Sep 3, 2027 to Aug 20, 2027
    • Study completion date: Aug 18, 2028 to Jul 21, 2028
  2. Enrollment closed, study ongoing Show 5 more changesShow less
    • Primary completion date: Sep 29, 2027 to Sep 3, 2027
    • Study completion date: Sep 13, 2028 to Aug 18, 2028
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 3 of 28 entries
    • Site details revised at 61 of 61 sites
  3. Primary endpoint(s) modified
    • Study sites: 60 to 61
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints: 8 to 28
    v19
  4. Trial sites expanded: 56 → 60 locationsv18
  5. Trial sites expanded: 53 → 56 locationsv17
  6. Study sites: 51 to 53v16
  7. Trial sites expanded: 47 → 51 locationsv15
  8. Study sites: 45 to 47v14
  9. Study sites: 43 to 45v13
  10. Trial sites expanded: 37 → 43 locationsv12
  11. Trial sites expanded: 33 → 37 locationsv11
  12. Trial sites expanded: 28 → 33 locationsv10
  13. Study sites: 26 to 28v9
  14. Study sites: 18 to 26v8
  15. Study sites: 15 to 18v7
  16. Study sites: 14 to 15v6
  17. Study sites: 12 to 14v5
  18. Study sites: 11 to 12v4
  19. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 6 to 11
    • Start date changed from estimate of Dec 17, 2025 to Dec 19, 2025
    v3
  20. Study sites: 0 to 6v2
  21. 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
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Obesity
3,898 trials monitored
See 160 trials at risk
This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea (OSA) who are receiving positive airway pressure (PAP) therapy and are living with overweight or obesity.
Trial Details
NCT Number NCT07225686
Lead Sponsor Amgen
Conditions
(from sponsor)		 Obesity, Obstructive Sleep Apnea
Related terms Obesity, Sleep Apnea, Obstructive
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov