A phase 3, randomized, controlled trial evaluated the efficacy and safety of resmetirom, an oral, liver-directed, thyroid hormone receptor beta-selective agonist, for the treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis. The study involved 966 adults with biopsy-confirmed NASH and fibrosis stages F1B, F2, or F3. Patients were randomly assigned to receive once-daily resmetirom at 80 mg, 100 mg, or placebo. The primary endpoints at week 52 were NASH resolution (with no worsening of fibrosis) and improvement in fibrosis by at least one stage with no worsening of the NAFLD activity score. Results showed that 25.9% of the 80-mg group and 29.9% of the 100-mg group achieved NASH resolution, compared to 9.7% in the placebo group. Similarly, 24.2% and 25.9% of the resmetirom groups achieved fibrosis improvement, versus 14.2% in the placebo group. Both doses of resmetirom significantly outperformed placebo in these endpoints. Resmetirom also reduced LDL cholesterol levels, with decreases of 13.6% and 16.3% in the 80-mg and 100-mg groups, respectively, compared to a 0.1% increase in the placebo group. Common side effects included diarrhea and nausea, which were more frequent with resmetirom than with placebo. The incidence of serious adverse events was similar across all groups. The study concluded that both 80-mg and 100-mg doses of resmetirom were superior to placebo in improving NASH and liver fibrosis.A phase 3, randomized, controlled trial evaluated the efficacy and safety of resmetirom, an oral, liver-directed, thyroid hormone receptor beta-selective agonist, for the treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis. The study involved 966 adults with biopsy-confirmed NASH and fibrosis stages F1B, F2, or F3. Patients were randomly assigned to receive once-daily resmetirom at 80 mg, 100 mg, or placebo. The primary endpoints at week 52 were NASH resolution (with no worsening of fibrosis) and improvement in fibrosis by at least one stage with no worsening of the NAFLD activity score. Results showed that 25.9% of the 80-mg group and 29.9% of the 100-mg group achieved NASH resolution, compared to 9.7% in the placebo group. Similarly, 24.2% and 25.9% of the resmetirom groups achieved fibrosis improvement, versus 14.2% in the placebo group. Both doses of resmetirom significantly outperformed placebo in these endpoints. Resmetirom also reduced LDL cholesterol levels, with decreases of 13.6% and 16.3% in the 80-mg and 100-mg groups, respectively, compared to a 0.1% increase in the placebo group. Common side effects included diarrhea and nausea, which were more frequent with resmetirom than with placebo. The incidence of serious adverse events was similar across all groups. The study concluded that both 80-mg and 100-mg doses of resmetirom were superior to placebo in improving NASH and liver fibrosis.