Clinical Trial

A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis

Study acronym: MAESTRO-NASH
Active, Not Recruiting Phase 3
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Summary
A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2019-03-30; most recent amendment 2026-05-28.
Status change: Recruiting → Active, Not Recruiting 2023-10-11
Trial Details
NCT Number NCT03900429
Lead Sponsor Madrigal Pharmaceuticals, Inc.
Conditions NASH - Nonalcoholic Steatohepatitis
Enrollment 1,759 participants
Start Date 2019-03-28
Primary Completion 2028-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-01