Boehringer Ingelheim and Zealand Pharma’s Phase II clinical trial evaluating the effect of different doses of BI 456906 in patients with obesity without type 2 diabetes has met its primary endpoint.
The randomised, parallel-group, dose-finding study compared subcutaneously administered BI 456906 subjects against placebo for 46 weeks.
After 46 weeks of treatment using a planned maintenance dose, patients treated with BI 456906 achieved a reduction in weight by up to 14.9%.
The study also included 20 weeks of dosing escalation and 26 weeks of maintenance.
Boehringer Ingelheim Human Pharma head Carinne Brouillon said: “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.
“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.”
Co-invented by Boehringer Ingelheim and Zealand Pharma, BI 456906 is also being assessed in a Phase II clinical trial in adults with NASH and liver fibrosis. The study is scheduled to be completed in the fourth quarter of this year.
In January, Boehringer Ingelheim reported positive data from the Phase IIb EFFISAYIL 2 clinical trial of spesolimab for generalised pustular psoriasis flares.