A differentiated glucagon/GLP-1 receptor dual agonist targeting obesity and MASH

Survodutide (BI 456906), licensed to Boehringer Ingelheim, is an investigational long-acting, glucagon/GLP-1 receptor dual agonist for once-weekly subcutaneous administration. Activating the glucagon and GLP-1 receptors simultaneously may reduce body weight by both increasing energy expenditure and reducing food intake.

The molecule is designed to leverage the body weight reduction and glycemic control of GLP-1 receptors with some activity on the glucagon receptors, which are present in the liver.

PROGRAM Survodutide
PARTNERS 300X180 Logo Boehringer
Phase 3

Development status

Boehringer Ingelheim is evaluating survodutide in global Phase 3 trials for people living with overweight and obesity, among key sub-populations. SYNCHRONIZE-1 and SYNCHRONIZE-2 include people living with comorbidities, without and with type 2 diabetes, respectively. The SYNCHRONIZE-CVOT trial includes people living with cardiovascular disease, chronic kidney disease, or with risk factors for cardiovascular disease. In addition, Boehringer Ingelheim is exploring survodutide in regional Phase 3 clinical trials in Japan (SYNCHRONIZE-JP) and in China (SYNCHRONIZE-CN) for sub-populations of people living with obesity.

Survodutide was previously evaluated in three Phase 2 clinical trials. The first was a Phase 2 trial with survodutide in people with type 2 diabetes on stable metformin background therapy showed dose-dependent decreases in blood sugar, HbA1c, after 16 weeks. The second Phase 2 trial with survodutide was in people living with overweight or obesity and demonstrated dose-dependent body weight reductions after 46 weeks. A third phase 2 trial with survodutide in people with metabolic dysfunction-associated steatohepatitis (MASH), showed improvements in MASH and liver fibrosis after 48 weeks. MASH is one of the most prevalent and serious obesity-related comorbidities.

Survodutide has been granted Fast Track Designation by U.S. Food and Drug Administration (FDA), as well as access to the Priority Medicine (PRIME) Scheme by the European Medicines Agency (EMA) for MASH with fibrosis.

Survodutide is an investigational compound whose safety and efficacy have not been evaluated or approved for marketing by any regulatory authority.

Related scientific publications

All scientific publications
  • EASL Congress

    Glucagon and GLP-1 receptor dual agonist survodutide improved liver histology in people with MASH and fibrosis: Results from a randomized, double-blind, placebo-controlled phase 2 trial

  • Diabetes, Obesity and Metabolism

    The dual GCGR/GLP-1R agonist survodutide: Biomarkers and pharmacological profiling for clinical candidate selection

  • The Lancet

    Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial

  • Diabetalogia

    Dose–response effects on HbA1c and bodyweight reduction of survodutide, a dual glucagon/GLP-1 receptor agonist, compared with placebo and open-label semaglutide in people with type 2 diabetes: a randomised clinical trial

Learn about clinical trials involving survodutide

Licensed to Boehringer Ingelheim

Survodutide is licensed to Boehringer Ingelheim, with Boehringer solely responsible for development and commercialization globally (subject to Zealand's co-promotion rights in the Nordic countries). Zealand is eligible for up to EUR 315 million in outstanding potential development, regulatory and commercial milestones, as well as high single to low double digit percentage royalties on global sales.

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    Overweight and obesity are associated with more than 220 complications and comorbidities, including cardiovascular disease, liver disease, type 2 diabetes, kidney disease, and neuroinflammation.

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