Cardiovascular outcomes with survodutide in adults with obesity at increased cardiovascular risk (SYNCHRONIZE-CVOT): a double-blind, randomised, placebo-controlled, phase 3 trial
Bozkurt B, le Roux CW, Wharton S, et al. (2026). The Lancet.
Summary
A phase 3 cardiovascular safety trial (SYNCHRONIZE-CVOT, NCT06077864) of weekly survodutide, a glucagon and GLP-1 receptor dual agonist, in 5,530 adults with obesity or overweight and established cardiovascular disease, chronic kidney disease, or at least two weight-related complications or risk factors. Participants were randomised to one of two survodutide dose levels or placebo. Over a median of 22.0 months, the primary composite (cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, ischaemia-related coronary revascularisation, or a heart failure event) occurred in 3.7% of the survodutide group (136 of 3,671) and 4.1% of the placebo group (76 of 1,836), a hazard ratio of 0.89 (95% confidence interval 0.67 to 1.18). The trial met its non-inferiority test. It is a safety trial in people: the result is that survodutide did not raise the rate of these heart events, and the confidence interval includes no difference, so the trial was not built to show a reduction. On a secondary weight endpoint, using the supplementary estimand (the effect expected if treatment continued), body weight at 72 weeks fell by up to 13.7% with survodutide against 2.0% with placebo. Gastrointestinal adverse events led 19.3% and 20.8% of participants on the two survodutide dose levels to stop treatment, against 1.9% on placebo. Published online on 9 November 2026 and presented the same day at the American Heart Association Scientific Sessions. Funded by Boehringer Ingelheim. Survodutide is investigational and not an approved medicine.