BI 1404-0044 A randomised, double-blind, placebo-controlled, multicentre, Phase III trial evaluating long-term efficacy and safety of Survodutide weekly injections in adult participants patients with non-cirrhotic non-alcoholic steatohepatitis/metabolic associated steatohepatitis (NASH/MASH) and (F2) - (F3) stage of liver fibrosis

A weekly injection of survodutide is being tested against placebo in people with a severe form of fatty liver disease that has already begun to scar the liver. This trial addresses a major gap: there are currently no approved drugs for non-alcoholic steatohepatitis (NASH, now also called MASH), a condition that can progress to cirrhosis, liver failure, and cancer. The disease affects millions worldwide, but treatment options remain limited to lifestyle changes. Survodutide, a dual hormone receptor agonist, aims to reduce liver fat and inflammation and halt or reverse fibrosis—the scarring that stiffens the liver. If the trial succeeds, survodutide could become the first licensed therapy for NASH/MASH with moderate-to-advanced fibrosis. That would give clinicians a tool to prevent progression to cirrhosis in patients who currently have no pharmacological option. The impact would be felt in hepatology clinics and transplant waiting lists, where NASH is a growing cause of liver failure. The trial is event-driven, meaning it continues until a pre-specified number of primary endpoint events occur, rather than running for a fixed duration.