Investigational Antiobesity Drug from Boehringer Ingelheim Meets Primary Endpoint in Phase 2 Trial
Individuals with overweight or obesity treated with a novel investigational dual glucagon/glucagon-like peptide-1 receptor agonist (GLP-1 RA) reached up to a 14.9% weight loss at 46 weeks, according to an announcement from development partners Boehringer Ingelheim (BI) and Zealand Pharma A/S.
In the phase 2 dose-finding trial of BI 456906 (see Figure, below), the reported reduction in body weight among the study participants, none of whom had type 2 diabetes, was achieved with the planned maintenance dose. The randomized parallel group study of the subcutaneously administered dual glucagon/GLP-1 RA included 20 weeks of dose escalation and 26 weeks of maintenance, according to the joint announcement.
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Full data from the study are currently under embargo with plans for the results to be presented at the 2023 American Diabetes Association’s 83rd Scientific Sessions, June 23-26, in San Diego. That data set will include analysis of all participants receiving the maintenance dose which may demonstrate even greater weight loss than observed in these midstage findings.
The drug is also in development as a treatment for non-alcoholic steatohepatitis, according to the companies, and is currently being evaluated in in a phase 2 study, expected to be completed in the fourth quarter of 2023.
“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, BI head of human pharma, in news release. “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.”
BI and Zealand Pharma’s novel dual agonist for treatment of overweight and obesity follows 2 other GLP-1 RA-based medications. Semaglutide is a GLP-1 RA (Wegovy, Novo Nordisk), approved by the US food and Drug administration in June 2021 for chronic weight management in adults with obesity and overweight with at least one weight-related comorbidity. In the phase 3 registration trial semaglutide was associated with a mean weight loss of 17-18% over 68 weeks.
Tirzepatide (Eli Lilly and Company) is a dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA awarded fast-track designation for chronic weight management in adults by the FDA in October 2022 and likely to receive approval of its new drug application before the end of 2023. In the most recent phase 3 SURMOUNT trial, tirzepatide-treated patients lost a mean 15.7% of baseline body weight over 68 weeks.
