Resmetirom Benefits Are Confirmed in the Approved F2–F3 MASH Population: Alimentary Pharmacology & Therapeutics | October 2026 issue

What Did the Study Find?

This analysis restricted MAESTRO-NASH to 917 patients with biopsy-confirmed F2 or F3 fibrosis, aligning the trial population with the clinical indication for resmetirom. Participants had originally been randomized to resmetirom 80 mg, 100 mg or placebo once daily for 52 weeks.

MASH resolution without fibrosis worsening occurred in 25.7% with 80 mg, 29.9% with 100 mg and 9.5% with placebo—absolute improvements of 16.2 and 20.4 percentage points. At least one-stage fibrosis improvement without worsening disease activity occurred in 26.5%, 28.9% and 17.3%, respectively. By week 24, LDL cholesterol decreased 11.7% and 13.7% with resmetirom but increased 2.3% with placebo. No new safety signal emerged. PubMed

Why Does It Matter?

The analysis confirms that efficacy is maintained after removing F1 patients who fall outside the principal treatment population. However, it is post hoc, industry-supported and based on 52-week histological surrogates—not demonstrated reductions in decompensation, transplantation, cardiovascular events or mortality.

GastroAGI Takeaway

In noncirrhotic MASH with confirmed F2–F3 fibrosis, resmetirom offers meaningful but incomplete histological benefit; accurate fibrosis staging and continued metabolic-risk control remain essential.