Tirzepatide produced MASH resolution at 44–62% at 52 weeks. Phase 3 advancing.
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% | 54% | 51% | 51% |
Implications
Phase 3 advancing. Plausible 2027 FDA MASH indication for tirzepatide. Companion semaglutide trial (ESSENCE) showed similar interim results.