For patients with nonalcoholic steatohepatitis (NASH) and fibrosis stage F1B, F2, or F3, 80- and 100-mg resmetirom is better than placebo, according to a study published in the Feb. 8 issue of the New England Journal of Medicine.

Stephen A. Harrison, M.D., from the University of Oxford in the United Kingdom, and colleagues conducted an ongoing phase 3 trial involving adults with biopsy-confirmed NASH and fibrosis stage of F1B, F2, or F3. The primary analysis population included 966 patients who were randomly assigned to receive once-daily resmetirom 80 mg, 100 mg, or placebo (322, 323, and 321 patients, respectively). The two primary end points were NASH resolution with no worsening of fibrosis and an improvement in fibrosis by at least one stage with no worsening of nonalcoholic fatty liver disease (NAFLD) activity score, both at week 52.

The researchers found that NASH resolution with no worsening of fibrosis was achieved in 25.9, 29.9, and 9.7 percent of patients in the 80- and 100-mg resmetirom and placebo groups, respectively. Fibrosis improvement by at least one stage with no worsening of the NAFLD activity score was achieved in 24.2, 25.9, and 14.2 percent of patients in the 80- and 100-mg resmetirom and placebo groups, respectively. From baseline to week 24, the change in low-density lipoprotein cholesterol levels was −13.6, −16.3, and 0.1 percent in the 80- and 100-mg resmetirom and placebo groups, respectively.

“Data for the first 1,050 patients from the MAESTRO-NASH trial, together with data from completed resmetirom trials, support the potential for resmetirom to provide benefit to patients with NASH and liver fibrosis,” the authors write.

The study was funded by Madrigal Pharmaceuticals, the manufacturer of resmetirom.

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