Study S000222

A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes

ClinicalTrials.gov record

Registration

Registration: NCT07165028
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: SINGLE
Status: RECRUITING
Enrollment: 4500
Start: 2025-10-15
Primary completion: 2030-08
Lead sponsor: Eli Lilly and Company
Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease
Interventions: DRUG:Tirzepatide; DRUG:Retatrutide; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: CTIS:2025-522674-36-00; OTHER:N1T-MC-MALO; OTHER:N1T-MC-TZ01; OTHER:N1T-MC-RT01; NIH:2025

Registered primary outcomes

Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO) [Baseline up to Study Completion (about 224 weeks)]

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