Resmetirom in the management of metabolic associated steatohepatitis (MASH): a review of efficacy and safety data from clinical trials

Abstract

Abstract Background Nonalcoholic steatohepatitis (NASH), now metabolic-associated steatohepatitis (MASH), is a progressive liver disease with limited treatment options. This review evaluated the efficacy and safety of resmetirom, a selective thyroid hormone receptor beta (THR-β) agonist, for MASH treatment. Methodology A search was made on the prominent electronic database, and original studies such as randomised controlled clinical trials that met the inclusion criteria were selected. We analyzed data from seven studies investigating resmetirom’s effects on liver fat content, liver fibrosis, metabolic parameters, and safety profile in patients with MASH. Result Resmetirom demonstrated significant improvements in MASH resolution and liver fibrosis compared to placebo in Phase III studies in tandem with the surrogate endpoints suggested by the FDA. It also reduced hepatic fat content in most studies, with the exception of one investigating a healthy subject. Additionally, resmetirom improved lipid profiles and quality of life in some studies. The safety profile appeared favourable, with a low incidence of adverse events, mostly mild or moderate. Conclusion Resmetirom is a recently approved FDA drug for MASH. It targets multiple pathways involved in the disease, including fat metabolism, inflammation, and fibrosis. Clinical trials revealed reductions in hepatic fat, improvements in liver fibrosis, and positive effects on metabolic health and quality of life. While long-term safety data is still required, resmetirom offers promise for MASH treatment. Future research should focus on long-term studies and optimizing treatment regimens for MASH patients.