Survodutide Shows Heart Safety in Obesity Trial

Survodutide, a glucagon and GLP-1 dual agonist from Boehringer Ingelheim, demonstrated a favorable cardiovascular safety profile in a survodutide cardiovascular safety obesity trial, a global Phase 3 trial in people with obesity and established cardiovascular disease, chronic kidney disease, or at least two weight-related complications or risk factors. The results, presented on November 9 at the American Heart Association Scientific Sessions in Chicago and published in The Lancet, come from SYNCHRONIZE-CVOT, the first and only global cardiovascular safety trial of a glucagon and GLP-1 dual agonist to date. The trial met its primary endpoint, showing that survodutide did not increase the risk of major adverse cardiovascular events compared with placebo.

The trial population was at elevated cardiovascular risk, including people with type 2 diabetes, and the safety question was central because any weight medicine intended for long-term use in this group must not raise the chance of serious cardiovascular problems. The hazard ratio for major adverse cardiovascular events was 0.89, with a 95 percent confidence interval of 0.67 to 1.18, a result that met the test for non-inferiority. Survodutide also showed meaningful improvements across multiple cardiometabolic measures, including reductions in systolic blood pressure and waist circumference at 72 weeks versus placebo.

Weight and health gains in the survodutide cardiovascular safety obesity trial

Secondary results showed weight loss of up to 13.7 percent at week 72, using the supplementary secondary estimand, in a population at elevated cardiovascular risk, versus 2.0 percent in the placebo arm. Systolic blood pressure fell by up to 6.68 mm Hg with survodutide, compared with 1.76 mm Hg with placebo, and waist circumference fell by up to 11.96 cm, versus 2.74 cm with placebo. Those changes, taken together, suggest that the medicine can improve several risk factors at once, rather than weight alone, although the trial was designed to test safety, not to prove a reduction in cardiovascular events.

Survodutide has not been approved for use, and its efficacy and safety have not been established by regulators. Further Phase 3 studies are planned, including trials in type 2 diabetes and in liver disease, and the company said it will continue to study the medicine in those settings. For now, the trial provides the first large-scale cardiovascular safety data for this class of dual agonist, and it will inform future decisions about whether the medicine can move toward approval for people with obesity and cardiovascular risk.

Source: GlobeNewswire