clinical trial · NCT03900429
A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
NASH - Nonalcoholic SteatohepatitisMGL-3196PlaceboLiver Biopsy
brief 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
started
Mar 28, 2019
primary completion
Jan 1, 2028
completion
Jan 1, 2028
last updated
Feb 20, 2024
detailed 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.
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol