Boehringer Ingelheim reported positive topline results from the Phase III SYNCHRONIZE-1 trial of survodutide (BI 456906), a dual glucagon/GLP‑1 receptor agonist, in adults with obesity or overweight without type 2 diabetes. In the study, survodutide met both co‑primary endpoints under the efficacy and treatment‑regimen estimands. Participants treated with survodutide achieved sustained mean weight loss of up to 16.6% at 76 weeks using the efficacy estimand, compared with 3.2% in the placebo arm, a statistically significant difference (p<0.0001). Full trial data are expected to be presented at the American Diabetes Association 2026 Scientific Sessions.
The trial also met its second co‑primary endpoint. Up to 85.1% of adults receiving survodutide achieved at least 5% body‑weight reduction at week 76 under the efficacy estimand, versus 38.8% in the placebo group (p<0.0001). Initial analyses indicate that weight reduction with survodutide was largely attributable to loss of fat tissue, with lean mass contributing only a small portion of the total weight loss. In a key secondary endpoint, survodutide produced a statistically significant reduction in waist circumference at 76 weeks compared with placebo, a measure closely associated with visceral fat and cardiometabolic risk.
Survodutide is designed as a dual glucagon/GLP‑1 receptor agonist. Its GLP‑1 activity is intended to reduce appetite and increase fullness and satiety, while its glucagon activity is thought to act directly on the liver to reduce hepatic fat, regulate metabolic function, resolve inflammation, and improve fibrosis. Obesity is described as a chronic, complex metabolic disease affecting more than one in eight people globally and is closely linked to conditions including liver disease, type 2 diabetes, cardiovascular disease, and metabolic dysfunction‑associated steatohepatitis (MASH).
In SYNCHRONIZE‑1, gastrointestinal events typical of GLP‑1–based therapies were observed, with trial discontinuations occurring more often during the dose‑escalation phase. These events were characterized as mild to moderate and temporary, with no new safety findings beyond those expected for the GLP‑1 class. Survodutide remains an investigational agent and has not been approved; its overall efficacy and safety profile has not yet been established.
SYNCHRONIZE‑1 is part of Boehringer Ingelheim’s global Phase III obesity program, which is evaluating survodutide in people with overweight or obesity and in selected sub‑populations. Additional obesity program readouts are anticipated during 2026. Survodutide is also being assessed in two Phase III trials, LIVERAGE and LIVERAGE‑Cirrhosis, in adults with MASH and fibrosis stages 2 or 3 and in those with compensated MASH cirrhosis (fibrosis stage 4), respectively. The company noted that survivodutide is the first asset in a broader obesity pipeline that includes multiple investigational approaches, such as BI 3034701, a potential first‑in‑class triple GLP‑1/GIP/NPY2 receptor agonist peptide expected to enter Phase II in mid‑2026, as well as additional experimental oral treatment options.
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