Study S002221

A Phase 3, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Maridebart Cafraglutide Once Monthly Versus Semaglutide Once Weekly as Add-on Therapy to Metformin With or Without a Sodium-glucose Cotransporter-2 Inhibitor in Participants With Type 2 Diabetes

ClinicalTrials.gov record

Registration

Registration: NCT07866066
Acronym: MARITIME-T2D-3
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: NOT_YET_RECRUITING
Enrollment: 1300
Start: 2026-11-02
Primary completion: 2028-09-04
Lead sponsor: Amgen
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Maridebart cafraglutide; DRUG:Semaglutide
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: CTIS:2025-523772-22-00; NIH:2025

Registered primary outcomes

Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority] [Baseline to Week 68]

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