Drugs and FDA
Survodutide met cardiovascular safety goal in obesity trial
In a trial of 5,508 adults, survodutide was noninferior to placebo for cardiovascular events, but the study was designed to assess safety, not prove benefit.
Survodutide was noninferior to placebo for major cardiovascular events in the SYNCHRONIZE-CVOT trial, Healio reported. The trial included 5,508 adults with obesity or overweight and established cardiovascular disease, chronic kidney disease and/or at least two weight-related complications or risk factors for cardiovascular disease. It compared weekly survodutide at 3.6 mg and 6 mg with placebo. The primary outcome included cardiovascular death, nonfatal stroke, nonfatal heart attack, coronary revascularization or heart failure events.
The pooled survodutide group met the trial’s noninferiority goal for the primary outcome, with a treatment-regimen hazard ratio of 0.84 and 95% CI of 0.6-1.18. Healio reported that the study was designed to establish cardiovascular safety, not show that the drug reduced cardiovascular risk. Endpoints News reported that Boehringer Ingelheim plans to seek approval of survodutide for obesity next year.
