Resmetirom (MGL-3196) received accelerated FDA approval in March 2024 for treating MASH with moderate to advanced liver fibrosis (F2-F3). This approval followed the MAESTRO-NASH trial, which showed significant efficacy in resolving MASH and improving fibrosis without worsening steatohepatitis. Resmetirom achieved resolution of steatohepatitis in 26%-30% of patients, compared to 10% in the placebo group, and improved fibrosis in 24%-26%. This article provides updated guidance on patient selection, assessment, and monitoring based on these trial results.

The guidance recommends using noninvasive liver disease assessment (NILDA) methods such as imaging tests or historical liver biopsy to determine treatment eligibility. While liver biopsy remains the gold standard, imaging techniques like liver stiffness measurement (LSM) and magnetic resonance elastography (MRE) are preferred for fibrosis assessment. Comorbidities such as diabetes, obesity, and cardiovascular risk factors should be managed alongside resmetirom therapy, with lifestyle changes being essential for MASLD management. Monitoring for adverse events, including hepatotoxicity and thyroid function, is essential. Ongoing research may further 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. PMID: 39422487.