Study S000431

Phase 2b Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Maridebart Cafraglutide in Adult Participants Living With Elevated Liver Fat and Obesity or Overweight

ClinicalTrials.gov record

Registration

Registration: NCT07441252
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: DOUBLE
Status: ACTIVE_NOT_RECRUITING
Enrollment: 180
Start: 2026-03-05
Primary completion: 2027-08-25
Lead sponsor: Amgen
Conditions: Overweight or Obesity and Elevated Liver Fat
Interventions: DRUG:Maridebart cafraglutide; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: YES

Registered primary outcomes

Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52 [Baseline and Week 52]
Percent Change from Baseline in Body Weight at Week 52 [Baseline and Week 52]

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