• Phase II dose-finding trial met primary endpoint after 46 weeks of treatment, representing an important advancement of Boehringer Ingelheim’s cardio-renal-metabolic focus areas
  • Full data will be presented at the 2023 American Diabetes Association’s 83rd Scientific Sessions
  • Novel dual glucagon/GLP-1 receptor agonist BI 456906 is part of the collaboration between Boehringer Ingelheim and Zealand Pharma

INGELHEIM, Germany, and COPENHAGEN, Denmark I May 10, 2023 I Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) today announced that patients treated with BI 456906 achieved up to 14.9% weight loss after 46 weeks, using the planned maintenance dose. The phase II clinical trial evaluating the effect of different doses of the novel glucagon/GLP-1 receptor dual agonist BI 456906 in people living with obesity or overweight without type 2 diabetes (NCT04667377) met its primary endpoint. These results including an analysis of the actual maintenance dose indicating even greater weight loss will be presented at the 2023 American Diabetes Association’s 83rd Scientific Sessions in San Diego, CA, U.S. Until then, the data is under embargo.

“Obesity is one of many cardio-renal-metabolic diseases, which together represent one of the fastest growing health challenges worldwide. The distinct mode of action of BI 456906 targets multiple pathways pivotal to metabolic regulation, including those associated with obesity and liver diseases,” said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim. “With our longstanding heritage in cardio-renal-metabolic diseases, we are excited by the findings and potential implications for millions of people who urgently need healthcare solutions.”

“We are both enthusiastic about these data and encouraged by the clinical outcomes announced today,” said David Kendall, M.D., Chief Medical Officer, Zealand Pharma. “At Zealand Pharma we continue our long-term commitment to the discovery and development of novel differentiated peptide therapeutics that target critical metabolic pathways to achieve substantial weight loss while addressing the complex pathophysiology of overweight and obesity.”

In 2016, more than 1 billion people worldwide were living with cardio-renal-metabolic (CRM) diseases such as obesity, type 2 diabetes, chronic kidney disease, liver disease, heart failure and cardiovascular disease1-10. Obesity is a major global health challenge, and the worldwide prevalence has more than doubled over the past four decades11. The World Obesity Federation predicts that by 2025, 2.7 billion adults could be living with obesity or overweight, placing a high burden on individuals, healthcare systems and society11.

Notes to editors

About the study

This is a Phase II, randomized, parallel group, dose-finding study of subcutaneously administered BI 456906 for 46 weeks compared to placebo in people living with overweight or obesity. The trial included 20 weeks of dosing escalation and 26 weeks maintenance.

About BI 456906
The glucagon/GLP-1 receptor dual agonist activates both the GLP-1 and glucagon receptors that are critical to controlling metabolic functions. The dual agonist BI 456906 has the potential to be a new treatment that may offer clinically relevant benefit. It is part of Boehringer Ingelheim’s research and development portfolio in the cardio-renal-metabolic disease areas.

BI 456906 was co-invented by Boehringer Ingelheim and Zealand Pharma and is currently also being evaluated in a phase II study in adults with NASH and liver fibrosis (stages F1/F2/F3). The trial is expected to complete in Q4 2023. It has received U.S. FDA Fast Track Designation for adults with non-alcoholic steatohepatitis (NASH).

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 press 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.

About Zealand Pharma A/S 
Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products.

Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. that includes Boston. For more information about Zealand’s business and activities, please visit www.zealandpharma.com.

1.    Jager KJ, et al. A single number for advocacy and communication-worldwide more than 850 million individuals have kidney diseases. Kidney Int 2019;96:1048–1050.

2.    GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet 2017;390:1211–1259.

3.    GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: A systematic analysis for the Global Burden of Disease Study 2019. Lancet 2020;396:1204–1222.

4.    World Health Organization. Obesity and Overweight. 2021. Available at: https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight. Last accessed: January 2023.

5.    Alicic RZ, Rooney MT, & Tuttle KR. Diabetic kidney disease: Challenges, progress, and possibilities. Clin J Am Soc Nephrol 2017;12:2032–2045.

6.    Roth GA, et al. Global burden of cardiovascular diseases and risk factors, 1990–2019: Update from the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982–3021.

7.    Shetty A & Syn WK. Health and economic burden of nonalcoholic fatty liver disease in the United States and its impact on veterans. Fed Pract 2019;36:14–19.

8.    Mantovani A, et al. Complications, morbidity and mortality of nonalcoholic fatty liver disease. Metabolism 2020;111S:154170.

9.    Sidney S, et al. Recent trends in cardiovascular mortality in the United States and public health goals. JAMA Cardiol 2016;1:594–599.

10.  World Obesity Federation. Prevalence of Obesity. 2016. Available at: https://www.worldobesity.org/about/about-obesity/prevalence-of-obesity. Last accessed: January 2023.

11.  World Obesity Federation. Prevalence of Obesity. 2016. Available at: https://www.worldobesity.org/about/about-obesity/prevalence-of-obesity. Last accessed: January 2023.

SOURCE: Zealand Pharma