Study S001451

A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight With Type 2 Diabetes Mellitus

ClinicalTrials.gov record

Registration

Registration: NCT07684144
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: RECRUITING
Enrollment: 950
Start: 2026-07-29
Primary completion: 2027-12-26
Lead sponsor: Amgen
Conditions: Obesity; Overweight; Diabetes Mellitus, Type 2
Interventions: DRUG:Maridebart Cafraglutide; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: CTIS:2025-524788-19-00; OTHER:U1111-1332-0531; NIH:2025

Registered primary outcomes

Percent Change in Body Weight from Baseline of the Parent Trial (20210184) [Baseline of parent trial (20210184) to Week 48 of current trial]
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Baseline of current trial up to 60 weeks]

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