Resmetirom in MASH/NASH with Liver Fibrosis

Review by Prof. Ahad Eshraghian (Iran)

Study Summary 

Non-alcoholic steatohepatitis (NASH), recently renamed as metabolic dysfunction–associated steatohepatitis (MASH), is a rapidly growing disease worldwide and is a major reason for liver transplantation. Despite its increasing burden, there is no approved pharmacologic treatment for MASH with liver fibrosis. Recently, in a phase 3 randomized controlled trial, resmetirom, a liver-directed, thyroid hormone receptor beta (THR-β)–selective agonist, has been used to treat patients with MASH and liver fibrosis. Patients with MASH and a fibrosis stage of F1B, F2, or F3 were randomized in a 1:1:1 ratio to receive once daily resmetirom at a dose of 80 mg or 100 mg or placebo for 52 weeks. MASH resolution was achieved in 25.9%, 29.9% and 9.7 % of the patients in the 80-mg resmetirom group, 100-mg resmetirom group, and the placebo group, respectively (P<0.001). Fibrosis improvement by at least one stage was achieved in 24.2% of the patients in the 80-mg resmetirom group and 25.9% of those in the 100-mg resmetirom group, as compared with 14.2% of those in the placebo group (P<0.001).

Commentary 

The study demonstrated that resmetirom was effective in treatment of patients with NASH and could improve liver fibrosis. The result is promising and it would be interesting to include patients with stage 4 fibrosis and investigate efficacy of the drug among this subgroup of patients.

Citation

Harrison SA, et al. A phase 3, randomized, controlled trial of resmetirom in NASH with liver fibrosis. N Engl J Med 2024; 390:497-509

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