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Historically, management of metabolic dysfunction–associated steatohepatitis (MASH) was limited to lifestyle interventions. In 2024, resmetirom — an agonist of thyroid hormone–receptor β in the liver — became the first drug specifically approved for treating patients with MASH. In 2025, the U.S. FDA approved injectable semaglutide for adults with MASH and moderate-to-advanced liver fibrosis.
Approval followed publication of the ESSENCE randomized trial, in which semaglutide (2.4 mg once weekly) was compared with placebo in ≈800 adults (mean body–mass index [BMI], 35 kg/m2; half with diabetes) with biopsy-proven MASH and stage 2 or 3 fibrosis. At 72-week follow-up, 63% of patients who received semaglutide versus 34% who received placebo had h…