Boehringer Seeking Survodutide Approval After Reporting Favorable Data

Boehringer Ingelheim says it will seek global approvals for survodutide, which it describes as the first glucagon/GLP-1 dual agonist to demonstrate a favorable cardiovascular safety profile in a Phase 3 trial alongside significant cardiometabolic benefits.

The company says its SYNCHRONIZE-CVOT trial met its primary endpoint using both the treatment-regimen and supplementary secondary estimands. “The trial demonstrated that survodutide (BI 456906) did not increase the risk of major adverse cardiovascular events (5P-MACE: cardiovascular death, non-fatal MI, non-fatal stroke, coronary revascularization, or heart failure events) compared to placebo (HR 0.89 [95% CI: 0.67-1.18]; p<0.0001 for non-inferiority using the treatment-regimen estimand) 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.”

Key secondary endpoint data demonstrated that survodutide did not increase the risk of cardiovascular death, non-fatal stroke or non-fatal MI (3P-MACE) compared to placebo, it says. Other key secondary endpoints showed survodutide improved several cardiometabolic health markers. “A reduction in systolic blood pressure by up to 6.68 mmHg was seen using the supplementary secondary estimand compared with 1.76 mmHg in those receiving placebo (P= 0.0001), at 72 weeks,” the company says,

“For those receiving survodutide, a reduction in waist circumference of up to 11.96 cm was seen using the supplementary secondary estimand vs 2.74 cm with placebo,” it continues. “This reduction of waist circumference serves as a clinical marker closely linked to visceral fat and cardiometabolic risk.”

Data also showed that survodutide delivered meaningful weight loss of up to 13.7% at Week 72 in those at elevated cardiovascular risk including individuals with Type 2 diabetes versus 2.0% in the placebo arm,” the company adds.

Regarding safety, the company says the most commonly reported adverse events for survodutide were gastrointestinal (GI) events, which were mostly mild to moderate in severity, with nausea, vomiting, diarrhea, and constipation the most common compared to placebo.

Boehringer Ingelheim notes that survodutide is also being studied in two global Phase 3 clinical trials (LIVERAGE and LIVERAGE-Cirrhosis) to assess its efficacy and safety in adults with MASH and fibrosis stages 2 or 3 and in those with compensated MASH cirrhosis (fibrosis stage 4).