Retatrutide MASLD Phase 3 (NCT06859268) Enrollment Continues — 86% Phase 2 Liver-Fat Reduction Baseline; H1 2027 Topline Expected
Eli Lilly's retatrutide MASLD Phase 3 program (NCT06859268) continues enrollment across multiple international sites following the December 2025 Phase 2 readout that documented 86% mean liver-fat reduction at 48 weeks on 12 mg dosing. The Phase 3 trial enrolls adults with biopsy-confirmed MASH stages F2-F3 with primary endpoint at week 52 measuring MASH resolution without worsening of fibrosis. The 86% liver-fat reduction substantially exceeds the resmetirom 38-46% benchmark from the MAESTRO-NAFLD-1 reference cohort. Topline data is expected H1 2027; full results at AASLD or EASL 2027. The MASLD Phase 3 sits alongside TRIUMPH-3 (obesity + CVD) and TRIUMPH-OUTCOMES (10,000-patient cardiovascular outcomes trial reading 2027) as the second 2027 retatrutide catalyst. If positive, retatrutide files for MASH labeling alongside the obesity NDA — potentially within the same FDA submission window.