Boehringer Ingelheim to advance survodutide into three global Phase III studies in obesity

Boehringer Ingelheim today announced it will advance survodutide, its glucagon/GLP-1 receptor dual agonist, into three registrational Phase III studies for people living with overweight or obesity. This decision was based on recently presented data from a Phase II dose finding study in people living with overweight or obesity. The study demonstrated up to 19 percent weight loss after 46 weeks of treatment with survodutide.¹

“With a strong heritage in cardio-renal-metabolic disease, we are continuing to expand and accelerate our portfolio in this area with the aim of bringing survodutide to patients in need as quickly as possible,” said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim. “There is a significant unmet medical need for effective treatments for obesity. With its dual mode of action, survodutide has the potential to further improve outcomes for people living with the disease and its associated complications.” 

Insights from previous studies will now be applied to the design of three global Phase III studies, which will investigate the efficacy and safety of survodutide. Details of the studies will be disclosed prior to their initiation and enrollment of patients is planned before the end of 2023.

About Obesity

In 2016, more than 1.9 billion adults were overweight - defined as a body mass index (BMI) of 25 or more², of which over 650 million were living with obesity - defined as a BMI of 30 or more.³ The World Obesity Federation predicts that by 2025, 2.7 billion adults could be living with overweight or obesity, making it a global health challenge and placing a high burden on individuals, healthcare systems, and society.³ Overweight and obesity are complex chronic conditions involving abnormal or excessive fat accumulation that presents a risk to a person’s overall health.⁴

About Survodutide

Survodutide is a glucagon/GLP-1 receptor dual agonist that activates both the GLP-1 and glucagon receptors, which are critical to controlling metabolic functions.⁵ It is also evaluated in a Phase II study in adults with NASH and liver fibrosis (stages F1/F2/F3) with and without type 2 diabetes⁶ for which it received US FDA Fast Track Designation.⁷ Co-invented by Boehringer Ingelheim and Zealand Pharma, survodutide is part of Boehringer Ingelheim’s research and development portfolio in the cardio-renal-metabolic disease areas.

About Boehringer Ingelheim

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com.

Boehringer Ingelheim’s Intended Audiences Notice

This release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

References

¹Data shows nearly 19% weight loss in people with overweight or obesity in Boehringer Ingelheim and Zealand Pharma Phase II trial with survodutide (BI 456906). Available at https://www.boehringer-ingelheim.com/human-health/metabolic-diseases/obesity/phase-ii-clinical-trial-weight-loss-results.

²World Health Organization. Obesity and Overweight. Available at: https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight. Accessed June 2023.

³World Heart Federation. Obesity. 2015. Available at: https://world-heart-federation.org/what-we-do/obesity/#:~:text=Global%20estimates%20suggest%20that%20almost,overweight%20or%20obesity%20by%202025 . Accessed June 2023.

⁴Bray GA et al. Obesity: A chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Obes Rev 2017;18:715–723.

⁵T. Zimmerman et al. BI 456906: Discovery and preclinical pharmacology of a novel GCGR/GLP-1R dual agonist with robust anti-obesity efficacy. Molecular Metabolism. 2022;66:101633.

⁶ClinicalTrials.gov: A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3).Available at  https://clinicaltrials.gov/ct2/show/NCT04771273https://clinicaltrials.gov/ct2/show/NCT04771273 Accessed June 2023.

⁷Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for Investigational Treatment for NASH.
https://www.boehringer-ingelheim.com/us/press-release/boehringer-ingelheim-and-zealand-pharma-receive-fda-fast-track-designation. Accessed June 2023.