Boehringer Ingelheim has announced positive results from its Phase III SYNCHRONIZE-CVOT trial.

 

This, with its investigational obesity drug survodutide demonstrating cardiovascular safety while delivering significant improvements in weight loss and several key cardiometabolic health markers.

 

The global trial, the first and only cardiovascular safety outcomes trial to date of a glucagon/GLP-1 dual agonist, met its primary endpoint, showing that survodutide did not increase the risk of major adverse cardiovascular events compared with placebo.

 

The findings are significant for people living with obesity or overweight who also face elevated cardiovascular risks, including those with established cardiovascular disease (CVD), chronic kidney disease and other weight-related complications.

 

Survodutide demonstrated no increased risk of five-point major adverse cardiovascular event, which include cardiovascular death, non-fatal heart attack, non-fatal stroke, coronary revascularisation and heart failure events.

 

Beyond establishing cardiovascular safety, survodutide delivered improvements across several important measures of cardiometabolic health.

 

The trial's key secondary endpoints showed that the drug did not increase the risk of three-point major adverse cardiovascular events, comprising cardiovascular death, non-fatal stroke and non-fatal heart attack.

 

At 72 weeks, participants receiving survodutide recorded a reduction in systolic blood pressure of up to 6.68 mmHg, compared with 1.76 mmHg in the placebo group.

 

Waist circumference also fell substantially, with a reduction of up to 11.96 cm in the survodutide group against 2.74 cm with placebo. The reduction is clinically relevant because waist circumference is closely associated with visceral fat accumulation and cardiometabolic risk.

 

The drug also delivered weight loss of up to 13.7% at Week 72, compared with 2.0% in the placebo group, using the supplementary secondary estimand. The study population included people at elevated cardiovascular risk, including individuals with type 2 diabetes.

 

Significant improvements were also reported in metabolic biomarkers, including high-sensitivity C-reactive protein (hs-CRP), an inflammatory marker, and triglycerides, both associated with cardiovascular risk.

 

Taken together, the findings point to improvements in multiple dimensions of cardiometabolic health, alongside cardiovascular safety comparable to placebo.

 

"For people living with obesity, the clinical challenge extends beyond weight to the profound, often unrecognized effects of obesity, on cardiovascular and metabolic health,” said Biykem Bozkurt, Principal Investigator of the SYNCHRONIZE-CVOT trial. 

 

“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 program, these data help give us confidence in how we could manage obesity and related cardiometabolic risk.”

 

However, survodutide remains an investigational drug and has not been approved for use. Its efficacy and safety have not been established. Boehringer Ingelheim said it is moving ahead with preparations for regulatory submissions in obesity, based on the overall evidence generated through the SYNCHRONIZE clinical development programme.

 

"The SYNCHRONIZE-CVOT trial findings represent an important milestone for survodutide clinical development as this is the first time we have demonstrated survodutide safety with respect to major adverse cardiovascular events,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma, Boehringer Ingelheim. 

 

"Together with the growing body of evidence from the SYNCHRONIZE program, these results strengthen our confidence in the potential of survodutide’s dual-agonist approach to address underlying metabolic dysfunction and improve broader metabolic health beyond body weight alone. We remain committed to building evidence across interconnected metabolic diseases through our broader global clinical development program."