Beyond TRIUMPH-1 and TRANSCEND-T2D-1, Lilly confirmed at ADA that seven additional Phase 3 retatrutide readouts span obesity, type 2 diabetes, osteoarthritis, obstructive sleep apnea, chronic low-back pain, metabolic dysfunction-associated steatotic liver disease (MASLD), and the cardiometabolic-outcomes program. The MASLD readout is on track for H1 2027, and TRIUMPH-OUTCOMES (cardiovascular events in a 10,000-patient population) anchors the late-2027 timeline.
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.
Eli Lilly's retatrutide MASLD Phase 3 trial (NCT06859268) is enrolling, building on Phase 2 data that reported up to 86% liver-fat reduction at 48 weeks with 93% of 12 mg patients reaching normal liver fat. The MASLD trial will measure histological resolution of steatohepatitis without worsening fibrosis — the endpoint that drives FDA approval in the indication. The trial sits within the broader TRIUMPH program of seven Phase 3 retatrutide readouts due in 2026, after TRIUMPH-4 (28.7% mean weight loss with knee-osteoarthritis pain reduction) and TRANSCEND T2D1 (A1c down 1.7–2.0 pts in T2D). MASLD remains a regulatory test for incretins after Boehringer's survodutide LIVERAGE Phase 3 program.