Boehringer Ingelheim has reported positive topline results from the phase III SYNCHRONIZE‑1 trial, showing that its investigational dual glucagon/GLP‑1 agonist survodutide achieved sustained and clinically meaningful weight loss in adults with obesity or overweight.
Participants without type 2 diabetes lost up to an average of 16.6% of their body weight after 76 weeks using the efficacy estimand, compared with 3.2% for placebo.
The company said the trial met both co‑primary endpoints, with up to 85.1% of adults on survodutide achieving at least a 5% reduction in body weight versus 38.8% on placebo. Initial analysis suggested that most weight loss came from fat tissue, with lean mass contributing only a small proportion.
A key secondary endpoint also showed a statistically significant reduction in waist circumference, a marker closely linked to visceral fat and cardiometabolic risk. As a dual glucagon/GLP‑1 receptor agonist, survodutide may address obesity while supporting liver function, a central regulator of metabolic health.
Professor Carel le Roux, Global Coordinating Investigator of the trial, said: “I am encouraged by the data emerging from SYNCHRONIZE‑1, which continue to demonstrate survodutide’s potential as a clinically meaningful treatment option for people with the disease of obesity.”
He added: “There is an urgent need for new therapies that go beyond weight reduction alone to support meaningful improvements in metabolic health. Survodutide’s dual agonism is particularly exciting, as it offers a promising approach to addressing this significant unmet need in care.”
Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim, said: “Today’s SYNCHRONIZE‑1 topline results strengthen our confidence in survodutide as a treatment candidate capable of addressing obesity and potentially offering targeted weight loss to help address connected conditions including liver disease.”
He said: “Survodutide has the potential to be the first global glucagon/GLP‑1 dual agonist to help the more than 1 billion people living with obesity and MASH.”
Gastrointestinal events were consistent with the GLP‑1 class and were generally mild to moderate, occurring more frequently during dose escalation. No new safety concerns were observed.
Survodutide remains investigational and unapproved. Further phase 3 readouts are expected later in 2026, including data from the LIVERAGE and LIVERAGE‑Cirrhosis trials in MASH.
