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

NASH - Nonalcoholic Steatohepatitis Clinical Trial

Official title:
A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (Resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation

Clinical Trial 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

Clinical Trial Description

Primary and secondary endpoint population at Week 52 will be at least 900 patients, more than half fibrosis score 3 (F3), the remainder fibrosis score 2 (F2) and <10% fibrosis score F1B (F1B) based on final liver biopsy baseline fibrosis score. ;

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • NASH - Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease
Clinical Trial Details
NCT number NCT03900429
Study type Interventional
Source Madrigal Pharmaceuticals, Inc.
Contact
Status Active, not recruiting
Phase Phase 3
Start date March 28, 2019
Completion date January 2028
View Details
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