Sema 2.4 mg in MASH F2-F3. Phase 3 interim May 2026: ~62% MASH resolution at 72 weeks.
Trial design
Phase 3 RCT of semaglutide 2.4 mg weekly vs placebo in adults with biopsy-confirmed MASH and F2-F3 fibrosis. Primary endpoint: MASH resolution without worsening fibrosis at 72 weeks.
Interim results — May 2026
NEJM publication of pre-specified interim: approximately 62% MASH resolution with semaglutide vs ~17% placebo at 72 weeks. Fibrosis improvement also favored semaglutide. Adverse events consistent with class profile.
Implications
Plausible 2027 FDA MASH indication for semaglutide. Would complement expected tirzepatide MASH indication (SYNERGY-NASH). Both molecules positioned as MASH therapies pending final readouts.