A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis/Metabolic Dysfunction-associated Steatohepatitis (NASH/MASH) and (F2) - (F3) Stage of Liver Fibrosis
Boehringer Ingelheim is testing survodutide, a weekly injectable, versus placebo in 1,800 adults with MASH and moderate to advanced liver fibrosis (F2-F3). This placebo-controlled trial runs up to 7 years with dual primary endpoints: MASH resolution without fibrosis worsening and composite clinical outcomes including progression to cirrhosis. This positions Boehringer as the first major pharma to advance a dedicated MASH program into Phase 3, targeting a liver indication where Novo's semaglutide and Eli Lilly's tirzepatide have shown promise but lack specific approvals. The 7-year duration reflects the extended timeline needed to demonstrate meaningful liver outcomes in this progressive disease.