Tirzepatide produced MASH resolution in 44–62% of patients at 52 weeks in a phase 2 trial. No FDA MASH indication for tirzepatide yet.
Trial design
Loomba et al. (NEJM 2024): adults with biopsy-confirmed MASH and F2-F3 fibrosis. Tirz 5/10/15 mg vs placebo for 52 weeks.
Results
| Endpoint | Placebo | 5 mg | 10 mg | 15 mg |
|---|---|---|---|---|
| MASH resolution | 10% | 44% | 56% | 62% |
| Fibrosis improvement | 30% | 55% | 51% | 51% |
Implications
SYNERGY-NASH was a phase 2 trial of 190 patients. As of October 16, 2026, tirzepatide has no FDA-approved MASH indication. Semaglutide (Wegovy) received accelerated approval for MASH with F2 to F3 fibrosis in August 2025 based on the phase 3 ESSENCE trial, in which steatohepatitis resolved without worsening fibrosis in 62.9% on semaglutide 2.4 mg vs 34.3% on placebo at 72 weeks, and fibrosis improved in 36.8% vs 22.4%.