A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis

Nonalcoholic steatohepatitis (NASH) is a progressive liver disease with no approved treatment. Resmetirom is an oral, liver directed, thyroid hormone receptor beta selective agonist in development for treating NASH with liver fibrosis. This phase 3 trial involved adults with biopsy confirmed NASH and fibrosis stages F1B, F2, or F3. Patients were randomized to receive once-daily resmetirom (80 mg or 100 mg) or placebo. Primary endpoints at week 52 were NASH resolution with no worsening of fibrosis and fibrosis improvement by at least one stage with no worsening of the NAFLD activity score. Results showed significant improvements in both endpoints for resmetirom groups compared to placebo, with favorable safety profiles. The study supports resmetirom's potential as a treatment for NASH with liver fibrosis.

Nonalcoholic steatohepatitis (NASH) is a progressive liver disease with no approved treatment. Resmetirom is an oral, liver directed, thyroid hormone receptor beta selective agonist in development for treating NASH with liver fibrosis. This phase 3 trial involved adults with biopsy confirmed NASH and fibrosis stages F1B, F2, or F3. Patients were randomized to receive once-daily resmetirom (80 mg or 100 mg) or placebo. Primary endpoints at week 52 were NASH resolution with no worsening of fibrosis and fibrosis improvement by at least one stage with no worsening of the NAFLD activity score. Results showed significant improvements in both endpoints for resmetirom groups compared to placebo, with favorable safety profiles. The study supports resmetirom's potential as a treatment for NASH with liver fibrosis.