Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy

Study acronym: MARITIME-OSA-2
StatusActive, Not Recruiting
PhasePhase 3
SponsorAmgen
Started

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Record History

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  1. Minor Enrollment closed, study ongoing Show 4 more changesShow less
    • Primary completion moved earlier from Sep 29, 2027 to Aug 30, 2027
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 2 of 28 entries
    • Site details revised at 57 of 57 sites
  2. Minor Trial sites expanded: 54 → 57 locations
    • Eligibility criteria shortened, about 15 words
    • Secondary endpoints: 8 to 28
    v21
  3. Minor Study sites: 53 to 54v20
  4. Minor Trial sites expanded: 49 → 53 locationsv19
  5. Minor Trial sites expanded: 46 → 49 locationsv18
  6. Minor Trial sites expanded: 42 → 46 locationsv17
  7. Minor Trial sites expanded: 38 → 42 locationsv16
  8. Minor Trial sites expanded: 34 → 38 locationsv15
  9. Minor Study sites: 32 to 34v14
  10. Minor Trial sites expanded: 28 → 32 locationsv13
  11. Minor Study sites: 26 to 28v12
  12. Minor Study sites: 24 to 26v11
  13. Minor Study sites: 23 to 24v10
  14. Minor Study sites: 19 to 23v9
  15. Minor Study sites: 15 to 19v8
  16. Minor Re-verified, no change to tracked fieldsv7
  17. Minor Study sites: 13 to 15v6
  18. Minor Study sites: 12 to 13v5
  19. Minor Study sites: 8 to 12v4
  20. Minor Study sites: 5 to 8
    • Start date changed from estimate of Dec 17, 2025 to Nov 25, 2025
    v3
  21. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    v2
  22. Minor 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.
169 trials monitored
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3,888 trials monitored
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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 not on PAP therapy and are living with overweight or obesity.
Trial Details
NCT Number NCT07226765
Lead Sponsor Amgen
Conditions
(from sponsor)
Obstructive Sleep Apnea
Related terms Obesity, Overweight, Sleep Apnea, Obstructive
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov