Resmetirom for the treatment of NASH with liver fibrosis

According to a recent study, both the 80-mg dose and the 100-mg dose of resmetirom exhibited superior effectiveness compared to the placebo in terms of resolving NASH and improving liver fibrosis by at least one stage. The findings of this study were recently published in The New England Journal of Medicine.

In this phase 3, randomized, controlled trial, patients were assigned randomly, in a 1:1:1 ratio, to receive either 80 mg (n=322) or 100 mg (n=323) of resmetirom once daily, or a placebo (n=321). The two primary endpoints of the study at week 52 included resolution of NASH, which involved a reduction in the nonalcoholic fatty liver disease (NAFLD) activity score by ≥2 points as well as an improvement in fibrosis by at least one stage, with no worsening observed in the NAFLD activity score.

In the 80-mg resmetirom group, 25.9% of the patients achieved NASH resolution without worsening of fibrosis, while in the 100-mg resmetirom group, this was achieved by 29.9% of the patients. In comparison, only 9.7% of the patients in the placebo group achieved the same outcome. Improvement in fibrosis by at least one stage without worsening of the NAFLD activity score was noted in 24.2% of patients in the 80-mg resmetirom group and 25.9% in the 100-mg resmetirom group. In contrast, only 14.2% of patients in the placebo group experienced such improvement.

Thus, it can be concluded that in terms of NASH resolution and improvement in liver fibrosis by at least one stage, both the 80-mg dose and the 100-mg dose of resmetirom showed superiority over placebo.