Study S003238

A Phase 3 Multicenter, Open-label, Single-arm Trial Evaluating Home Self-Administration of Subcutaneous Maridebart Cafraglutide Via Autoinjector in Adult Participants Living With Obesity or Overweight Without Type 2 Diabetes Mellitus

ClinicalTrials.gov record

Registration

Registration: NCT07871409
Acronym: MARITIME-PEN
Study type: INTERVENTIONAL
Phase: PHASE3
Masking: NONE
Status: NOT_YET_RECRUITING
Enrollment: 230
Start: 2026-10-28
Primary completion: 2027-06-16
Lead sponsor: Amgen
Conditions: Obesity; Overweight
Interventions: DRUG:Maridebart cafraglutide; DEVICE:Autoinjector
Results posted: FALSE
Individual participant data sharing: YES

Registered primary outcomes

Percentage of Participants Who Successfully Self-inject a Full Dose Among Those Who Attempted Injection at Each Home Administration [Weeks 12, 16, and 20]
Percentage of Participants Who Successfully Self-inject a Full Dose Among All Participants Who Entered the Home Self-administration Phase at Each Scheduled Home Administration [Weeks 12, 16, and 20]

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