Resmetirom, a liver-directed thyroid hormone receptor-beta agonist, and semaglutide, a GLP-1 receptor agonist, both hold conditional FDA approval for metabolic dysfunction-associated steatohepatitis (MASH) with F2 to F3 fibrosis and without cirrhosis. This international expert panel review in Gut brings together the phase 3 data, the labels and early clinical experience into a single practical pathway.
It covers non-invasive diagnosis of significant fibrosis without biopsy, choosing between the two agents by patient phenotype, starting treatment, monitoring, defining response and non-response, and when to switch or combine. It also addresses patients already on a GLP-1 receptor agonist for diabetes or obesity.
For hepatologists and gastroenterologists, this is a usable framework while long-term outcome data accumulate. In India, semaglutide is available; resmetirom's regulatory status with CDSCO is not given in this review and is unknown here. The approvals are conditional, pending outcome data.
- Use non-invasive tests to identify F2 to F3 fibrosis before considering drug treatment for MASH.
- Consider semaglutide where obesity or type 2 diabetes is also an indication.
- Check whether patients already on a GLP-1 receptor agonist have reached the dose used in MASH trials.
- Define in advance how response will be judged, and plan when to switch or combine.
Why it matters
MASH with fibrosis has moved from no drug option to two, and clinicians need a shared pathway.
Don't overread it
Expert consensus built on surrogate-endpoint approvals; long-term outcome benefit is still unconfirmed.
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