Survodutide promising for Obesity with diabetes in Phase 3 trial

Topline phase 3 trial data in adults with obesity or overweight without type 2 diabetes show promise for survodutide, a dual glucagon and GLP-1 receptor agonist. Its mechanism combines appetite suppression and increased satiety (via GLP-1) with reduced liver fat and improved metabolic regulation (via glucagon).

Adults living with obesity or overweight, without type 2 diabetes, who were treated with survodutide experienced sustained weight loss of up to an average of 16.6% after 76 weeks using the efficacy estimand, a statistically significant decrease versus 3.2% in the placebo arm (p<0.0001). This level of weight loss supports survodutide’s potential as a clinically meaningful treatment option for people living with obesity or overweight.1 Full data from the Phase III trial will be presented at the upcoming American Diabetes Association’s (ADA) 2026 Scientific Sessions in June.

The trial met its other co-primary endpoint, with up to 85.1% of adults treated with survodutide achieving a body weight reduction of ≥5% after 76 weeks of treatment, using the efficacy estimand, versus 38.8% in the placebo arm (p<0.0001). Initial analysis indicates that body weight reduction with survodutide was driven predominantly by loss of fat tissue, with lean mass contributing only a small proportion of total weight.

In a key secondary endpoint, adults treated with survodutide experienced a statistically significant reduction in waist circumference – a clinical marker closely linked to visceral fat and cardiometabolic risk – after 76 weeks versus placebo.1 Excess visceral fat, particularly around the abdomen, is a known contributor to metabolic dysfunction and is closely connected to impaired liver function. As a dual glucagon/GLP‑1 receptor agonist, survodutide has the potential to address obesity while also supporting liver function, a key regulator of metabolic health.

“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,” said Professor Carel le Roux, M.D., Ph.D., Professor at University College in Dublin, Ireland, and Global Coordinating Investigator of the trial. “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.”

Obesity is a chronic, complex metabolic disease that impacts more than 1 in 8 people worldwide in many different ways, and can have serious long-term consequences. It is closely linked to serious conditions including liver disease, type 2 diabetes and cardiovascular disease. Notably, up to 1 in 3 people living with obesity develop a serious liver condition called metabolic dysfunction-associated steatohepatitis (MASH), characterized by inflammation and liver damage.

“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,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma, Boehringer Ingelheim. “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.”

Survodutide’s GLP‑1 agonism decreases appetite while increasing fullness and satiety,10 while its glucagon agonism is thought to directly act on the liver to reduce hepatic fat, regulate metabolic function, resolve inflammation, and improve fibrosis.

As expected with GLP-1 based therapies, participants in the trial experienced gastrointestinal events, with discontinuations happening more frequently during the dose escalation phase.1 These events were both mild to moderate in severity and temporary, with no new safety concerns observed outside of what is expected for the GLP-1 class.

Survodutide is an investigational agent and has not been approved for use; its efficacy and safety has not been established. SYNCHRONIZE-1 is part of a comprehensive global Phase III obesity program, evaluating survodutide in people living with overweight and obesity, among key sub-populations. Additional trial results are expected to read out during 2026. Survodutide is also being studied in two global Phase III clinical trials LIVERAGE and LIVERAGE-Cirrhosis investigating the efficacy and safety of survodutide in adults with MASH and fibrosis stages 2 or 3 and in those with compensated MASH cirrhosis (fibrosis stage 4).

Survodutide is the first in a broader portfolio of therapies being developed for people living with obesity or obesity and connected metabolic health conditions, with multiple approaches under investigation. This includes an investigational, potential first-in-class triple GLP-1, GIP, NPY2 receptor agonist peptide (BI 3034701), which will be entering Phase II in the middle of 2026, as well as additional experimental approaches including oral treatment options.