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Zealand Pharma announces Boehringer Ingelheim’s survodutide is the first glucagon/GLP-1 dual agonist to demonstrate a favorable cardiovascular safety profile in global Phase 3 SYNCHRONIZE-CVOT trial with significant cardiometabolic benefits

ZEAL
  • Boehringer Ingelheim reported positive results from the global Phase 3 SYNCHRONIZE-CVOT trial, making survodutide the first glucagon/GLP-1 dual agonist to demonstrate a favorable cardiovascular safety profile.
  • The trial met its primary endpoint for non-inferiority regarding major adverse cardiovascular events (5P-MACE) compared to placebo in adults with obesity, established cardiovascular disease, or chronic kidney disease.
  • Key secondary endpoints showed survodutide did not increase the risk of cardiovascular death, non-fatal stroke, or non-fatal MI (3P-MACE) versus placebo.
  • Significant cardiometabolic improvements were observed at 72 weeks, including systolic blood pressure reductions of up to 6.68 mmHg and waist circumference reductions of up to 11.96 cm.
  • Survodutide achieved weight loss of up to 13.7% at Week 72 in patients with elevated cardiovascular risk, including those with Type 2 Diabetes, compared to 2.0% with placebo.
  • The results were presented at the American Heart Association Scientific Sessions 2026 and published simultaneously in The Lancet.
  • David Kendall, Chief Medical Officer of Zealand Pharma, stated the registrational Phase 3 SYNCHRONIZE program is now complete following the SYNCHRONIZE-CVOT results.
  • Boehringer Ingelheim confirmed plans to move forward with global regulatory submissions for survodutide in obesity based on the totality of evidence.
  • The most common adverse events were gastrointestinal symptoms such as nausea, vomiting, diarrhea, and constipation, with discontinuation rates of 19.3% to 20.8% for survodutide doses versus 1.9% for placebo.
  • Future Phase 3b studies like SYNCHRONIZE-START aim to implement more flexible titration strategies to improve tolerability.
  • Survodutide is also being investigated in LIVERAGE and LIVERAGE-Cirrhosis trials for adults with MASH and fibrosis stages 2 to 4.
  • Boehringer Ingelheim holds the global license for survodutide from Zealand Pharma and is solely responsible for its development and commercialization.
Company
Zealand Pharma
Keywords
Copenhagen Stock Exchange:ZEAL, Zealand Pharma