Boehringer Ingelheim and Zealand Pharma A/S 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.

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. 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 fourth quarter for 2023. It has received U.S. FDA Fast Track Designation for adults with non-alcoholic steatohepatitis (NASH).