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Semaglutide showed Phase 3 efficacy in resolving steatohepatitis without fibrosis progression. FDA approval expected 2026-2027.
ESSENCE phase 3 (NEJM, 2025): at 72 weeks, 62.9% on semaglutide 2.4 mg had resolution of steatohepatitis with no worsening of fibrosis, vs 34.3% on placebo. On the second endpoint, 36.8% had fibrosis improvement with no worsening of steatohepatitis, vs 22.4%. That second one matters more for your long-term liver risk, and it is the smaller number — note the placebo arm improved too.
Novo Nordisk, Lilly. Hepatology adopting off-label for advanced MASLD.
Monitor ALT/AST during weight loss; transient elevations possible. Severe fibrosis (F3-F4) needs hepatology co-management.
The likely next FDA indication. Already prescribed off-label widely. See /conditions/fatty-liver for prescribing reality.
Editorial summary. Off-label use is legal but not FDA-evaluated. Insurance typically does not cover off-label prescriptions. Not medical advice.