en.Wedoany.com Reported - On June 7, Zealand Pharma announced that its partner Boehringer Ingelheim's glucagon/GLP-1 dual agonist survodutide (BI 456906) achieved positive results in two global Phase III clinical trials. These results demonstrate the drug's potential to improve metabolic health in obese patients, particularly in targeting harmful fat reduction.
The SYNCHRONIZE-1 trial was conducted in obese or overweight adults without type 2 diabetes over 76 weeks. Data showed that, using efficacy estimates, sustained weight loss averaged 16.6%, significantly superior to the placebo group's 3.2%. A prespecified analysis revealed that the drug reduced visceral fat by up to 34.0% and liver fat by up to 63.1%. The analysis also indicated that in the high-dose group, lean mass loss accounted for no more than 10.8% of total tissue mass changes, suggesting that weight loss was primarily driven by fat reduction.
Another trial, SYNCHRONIZE-MASLD, targeted obese or overweight adults with metabolic dysfunction-associated steatotic liver disease and evidence of inflammation and/or fibrosis. Results showed that up to 84.2% of participants treated with survodutide experienced at least a 30% relative reduction in liver fat, compared to 24.3% in the placebo group. Additionally, up to 6 out of every 10 patients achieved normalization of liver fat, with relative weight reduction of up to 12.2%. Positive trends were also observed in liver-related biomarkers.
The results of these two trials were presented at the American Diabetes Association's 2026 Scientific Sessions and published in the New England Journal of Medicine and Nature Medicine, respectively. Survodutide, by simultaneously activating glucagon and GLP-1 receptors, aims to reduce appetite while directly acting on the liver to decrease liver fat. The drug has received Fast Track designation and Breakthrough Therapy designation from the U.S. FDA and remains under investigation.
As part of a broader evidence program, Boehringer Ingelheim is advancing a series of Phase IIIb studies to further evaluate survodutide's potential in women's health, cardiac function and structural protection, and real-world dose titration. Additionally, the drug is being studied in two global Phase III trials for metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis.
Zealand Pharma stated that, under the collaboration agreement, the company is entitled to royalties on global sales of survodutide and potential milestone payments. The drug was licensed by Zealand Pharma to Boehringer Ingelheim, which is responsible for global development and commercialization.
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