Boehringer Ingelheim’s dual-targeting weight-loss drug, survodutide, has shown safety with respect to cardiovascular events in a Phase III trial.
In the SYNCHRONIZE-CVOT trial (NCT06077864), survodutide did not increase the risk of major adverse cardiovascular events (5P-MACE: cardiovascular death, non-fatal MI, non-fatal stroke, coronary revascularisation, or heart failure events) compared to placebo in adults living with obesity or overweight with established cardiovascular disease (CVD), chronic kidney disease, and/or at least two weight-related complications or risk factors for CVD. This meant the trial met its primary endpoint.
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Key secondary endpoint results showed that survodutide did not increase the risk of cardiovascular death, non-fatal stroke or non-fatal MI (3P-MACE) compared to placebo.
There were also improvements in several cardiometabolic health markers, including a reduction in systolic blood pressure by up to 6.68mmHg compared with 1.76mmHg in those receiving placebo at 72 weeks.
Significant reductions were seen in additional metabolic health biomarkers such as the inflammatory marker high-sensitivity C-reactive protein (hs-CRP) and triglycerides versus placebo, which are predictors of cardiovascular risk.
There was also weight loss reported of up to 13.7% at week 72 versus 2% in the placebo arm.
As expected with glucagon-like peptide-1 receptor agonist (GLP-1RA) therapies, the most commonly reported adverse events (AEs) for survodutide were gastrointestinal (GI) in nature. The treatment discontinuation rates due to GI adverse events were 19.3% and 20.8% in people who received 3.6mg and 6.0mg doses of survodutide, respectively, compared to 1.9% in the placebo arm.
Discontinuations usually occurred during the dose escalation phase, as the initial study protocol allowed limited flexibility to manage AEs through slower titration, dose adjustment, or longer temporary interruption.
Boehringer Ingelheim said that SYNCHRONIZE-CVOT is the first and only global cardiovascular safety trial of a dual glucagon/GLP-1RA. The full results from SYNCHRONIZE-CVOT were presented at the American Heart Association’s (AHA) Scientific Sessions 2026 in Chicago, Illinois, which took place from 6 to 9 November.
Based on the SYNCHRONIZE programme, the company said it will move forward with regulatory submissions for the obesity drug. The SYNCHRONIZE programme also includes the SYNCHRONIZE-1 study (NCT06066515), which evaluated survodutide in adults living with overweight or obesity without type 2 diabetes, in which there was an average sustained weight loss of up to 16.6% at 76 weeks compared to 3.2% with a placebo. It also includes SYNCHRONIZE-2 (NCT06066528), which enrolled patients with overweight or obesity and type 2 diabetes, in which patients achieved an average 13.1% weight loss versus 3.1% for placebo, with HbA1c reductions of up to 1.21%. The programme also features a study of the drug in metabolic dysfunction-associated steatotic liver disease (MASLD).
Dr Biykem Bozkurt, principal investigator of the SYNCHRONIZE-CVOT trial, said: “For people living with obesity, the clinical challenge extends beyond weight to the profound, often unrecognised effects of obesity on cardiovascular and metabolic health. We are looking at novel therapeutic approaches that do not merely reduce body weight but can also improve metabolic dysfunction while maintaining cardiovascular safety. Combined with the breadth of evidence from the SYNCHRONIZE programme, these data help give us confidence in how we could manage obesity and related cardiometabolic risk.”
Obesity is a chronic, complex metabolic disease that can contribute to metabolic dysfunction, which can develop silently and progressively increase the likelihood of cardiometabolic conditions such as type 2 diabetes, cardiovascular disease, chronic kidney disease and MASLD/MASH.
In addition to the SYNCHRONIZE programme, survodutide is being studied in two global Phase III clinical trials, LIVERAGE (NCT06632444) and LIVERAGE-Cirrhosis (NCT06632457), 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).
The obesity sector as a whole has grown significantly in recent years, with Eli Lilly and Novo at the helm. In Q3 2026, Lilly’s sales of its weight loss drug tirzepatide, marketed at Mounjaro and Zepbound, were higher alone that some big pharma companies’ full Q3 takings.
In 2025, GlobalData estimated the total obesity market to be valued at $34.6bn across the seven major markets (7MM: US, France, Germany, Spain, Italy, UK and Japan), with the US accounting for 82.6% of the market. Over the forecast period, the obesity market is anticipated to grow to a value of $118.2bn in 2035.
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