Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)

StatusRecruiting
PhasePhase 3
SponsorAmgen
Started

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Record History

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  1. Trial sites expanded: 87 → 92 locations
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 2 of 11 entries
  2. Trial sites expanded: 83 → 87 locationsv4
  3. Trial sites expanded: 31 → 83 locationsv3
  4. Recruitment opened
    • Trial sites expanded: 0 → 31 locations
    • Start date changed from estimate of Jul 29, 2026 to Jul 23, 2026
    v2
  5. 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
169 trials monitored
See 11 trials at risk
Obesity
3,888 trials monitored
See 157 trials at risk
The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).
Trial Details
NCT Number NCT07684235
Lead Sponsor Amgen
Conditions
(from sponsor)		 Obesity, Overweight
Related terms Obesity, Overweight
Enrollment 3,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov