Resmetirom received accelerated FDA approval in March 2024 for treating metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced fibrosis (F2-F3), based on positive outcomes from the MAESTRO-NASH and MAESTRO-NAFLD-1 trials. It showed efficacy in resolving steatohepatitis and improving fibrosis without worsening other disease markers. Because the FDA label lacks detailed clinical guidance, the AASLD issued interim recommendations based on available data. Resmetirom may be prescribed without biopsy if noninvasive assessments (NILDA), such as VCTE or MRE, suggest steatosis and fibrosis in patients with cardiometabolic risk factors.

Monitoring safety and efficacy is key. Liver function tests should be performed regularly, and treatment stopped if hepatotoxicity occurs. Resmetirom is generally well tolerated, though diarrhea and nausea are common. Thyroid and lipid levels should be monitored due to possible hormonal and drug interaction effects. A ≥25% reduction in VCTE or ≥20% in MRE liver stiffness, along with ALT improvement, may signal treatment response. If no improvement or worsening is seen after 12 months, clinicians should assess whether to continue based on fibrosis status, comorbidities, and treatment response. Ongoing trials will help refine these recommendations.

Reference: Chen VL, Morgan TR, Rotman Y, et al. Resmetirom therapy for metabolic dysfunction-associated steatotic liver disease: October 2024 updates to AASLD Practice Guidance. Hepatology. 2025 Jan 1;81(1):312-320. doi: 10.1097/HEP.0000000000001112. Epub 2024 Oct 18. Erratum in: Hepatology. 2025 Apr 1;81(4):E133. doi: 10.1097/HEP.0000000000001186. PMID: 39422487.