Resmetirom, a liver-directed thyroid hormone receptor-beta agonist, and semaglutide, a GLP-1 receptor agonist, now both hold conditional FDA approval for MASH with moderate to advanced fibrosis (F2–F3) without cirrhosis. An international expert panel in Gut (11 September) pulled together the phase 3 trials, labels and early clinical experience into one practical pathway.
The review covers diagnosing MASH with significant fibrosis using non-invasive tests rather than biopsy, choosing between the two drugs according to the patient's phenotype, handling patients already on a GLP-1 receptor agonist for diabetes or obesity, monitoring on treatment, and defining response, non-response and when to switch or combine.
This is expert opinion built on trial data, not a new trial, and both approvals are conditional pending outcome data. For hepatologists and gastroenterologists it is the most complete current guide to using these drugs. In India, semaglutide is available but resmetirom's regulatory status is not established here, and neither carries an Indian indication for MASH that this edition can confirm.
- Identify MASH with F2–F3 fibrosis using non-invasive tests before considering drug treatment.
- Consider the patient's metabolic phenotype and existing GLP-1 receptor agonist use when choosing therapy.
- Agree in advance how response will be assessed and when non-response triggers a switch.
- Both approvals are conditional; long-term outcome data are awaited.
Why it matters
Clinicians now have two drugs for a disease that had none, and need a shared framework for using them.
Don't overread it
This is an expert review; approvals are conditional and outcome benefits are not yet shown.
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