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Semaglutide showed Phase 3 efficacy in resolving steatohepatitis without fibrosis progression. FDA approval expected 2026-2027.
ESSENCE Phase 3 (2024): 63% of patients on semaglutide 2.4 mg resolved MASH at 72 weeks vs 34% placebo. Tirzepatide Phase 2 shows similar effect.
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.