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

Study acronym: MARITIME-OSA-1
StatusRecruiting
PhasePhase 3
SponsorAmgen
Started2025-12-19
View on ClinicalTrials.gov ↗
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.

Amendment history 7 changes detected by DataLookout

2026-08-05
critical
Primary endpoint(s) modified
WasChange in AHI from baseline at week 52
NowChange in Apnea-Hypopnea Index (AHI) from baseline at week 52
2026-06-13
minor
Trial sites expanded: 56 → 60 locations
2026-05-23
minor
Trial sites expanded: 53 → 56 locations
2026-05-06
minor
Trial sites expanded: 47 → 51 locations
2026-04-10
minor
Trial sites expanded: 37 → 43 locations
2026-04-03
minor
Trial sites expanded: 33 → 37 locations
2026-03-31
minor
Trial sites expanded: 28 → 33 locations
Trial Details
NCT Number NCT07225686
Lead Sponsor Amgen
Conditions Obesity, Obstructive Sleep Apnea
Enrollment 250 participants
Start Date 2025-12-19
Primary Completion 2027-09-29 (estimated)
Study Completion 2028-09-13 (estimated)
Updated on ClinicalTrials.gov 2026-08-04