Zealand Pharma A/S (ZEAL.CO), a biotechnology company, announced on Tuesday that Boehringer Ingelheim reported promising topline results from the Phase 3 SYNCHRONIZE-1 trial for Survodutide, a weight loss drug for overweight or obese patients without type-2 diabetes.
Survodutide is a glucagon/GLP-1 dual agonist, targeting both the glucagon and GLP-1 receptors to control metabolic functions. It is currently being evaluated in the SYNCHRONIZE studies to treat patients with obesity, including market trials in China and Japan, and in the LIVERAGE studies for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
For treating non-cirrhotic MASH and advanced fibroids, survodutide has received a fast track designation in 2021, and a breakthrough designation in 2024 from the U.S. Food and Drug Administration (FDA). Additionally, the drug has been recognized under the PRIME scheme by the European Medicines Agency (EMA), and as a breakthrough therapy in China and Taiwan.
The drug was licensed from Zealand Pharma to Boehringer Ingelheim, which is responsible for development and global commercialization of survodutide. Zealand Pharma, in turn, will receive high-single digit to low-double digit royalties from future sales of the treatment.
Phase 3 SYNCHRONIZE-1 is a global, double-blind, placebo-controlled trial conducted on 725 patients over 76 weeks. The study evaluates the safety and efficacy of survodutide administered in doses of 3.6 mg to 6.0 mg, to overweight or obese patients without type-2 diabetes.
Topline results indicate that the primary endpoints have been met, with patients showing an average sustained weight loss of 16.6% after 76 weeks. The other co-primary endpoint was also acheived, with a body weight reduction of =5% recorded, implying a loss of fat tissue in patients receiving treatment. Of the 31 secondary endpoints, a key secondary endpoint was also met, as patients showed reduced waist circumferences after treatment.
Complete data from the Phase 3 SYNCHRONIZE trial are expected to be announced at the American Diabetes Association (ADA) scientific sessions in June, 2026. The company is also advancing trials for survodutide in patients with cardiovascular or chronic kidney diseases.
ZEAL.CO is currently trading on the Copenhagen Stock Exchange at DKK 317.90, up 4.88%.
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