BI 456906 Shows Promise, Reducing Body Weight Up to 14.9%, in Phase 2 Trial

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A new face may soon introduce itself to treatment algorithms for chronic weight management, as topline data from a phase 2 trial suggests use of a dual glucagon/GLP-1 receptor agonist, called BI 456906, could help patients lose up to 14.9% of their body weight after 46 weeks in people with obesity or overweight without type 2 diabetes.

The excitement surrounding development in the world of obesity management has been at a fever pitch since the presentation of SURMOUNT-1 results at the American Diabetes Association (ADA) 2022 Scientific Sessions.² Now, fast-forward to May 10, 2023, and Boehringer Ingelheim and Zealand Pharma are hopeful to drum up the same fervor as they announced plans to present the results of their phase 2 dose-finding trial for BI 456906 at the upcoming ADA 2023 Scientific Sessions in less than 2 months.¹

“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.¹ “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.”

Launched in March 2021, the phase 2 dose-finding study of BI45906 enrolled adult patients aged 18-75 years with overweight or obesity and randomized them to 1 of 4 doses of once-weekly BI 456906 delivered subcutaneously or placebo therapy. Per trial protocol, patients received escalating doses of BI 456906 for the first 20 weeks and the final 26 weeks of the 46-week treatment period was considered a maintenance phase.¹

According to ClinicalTrials.gov, the trial enrolled a total of 387 participants. The primary outcome of interest for the trial was the percentage change in body weight from baseline to week 46. Secondary outcomes of interest included the proportion of patients achieving weight loss equal to or exceeding 5, 10, and 15% of baseline body weight as well as absolute change in body weight, waist circumference, and other metrics. For inclusion in the trial, patients need to be between 18-75 years of age, have a BMI of 27 k/m2 or greater at baseline, and must have undergone at least 1 previous unsuccessful nonsurgical weight-loss attempt.³

In their announcement, Boehringer Ingelheim noted, in addition to the main study results, plans to present an additional analysis of the actual maintenance dose indicating even greater weight loss at ADA 2023. The company also pointed out this agent is also being evaluated in a phase 2 study for adults with nonalcoholic steatohepatitis and liver fibrosis, with this trial expected to be completed in Q4 of 2023.¹

“We are both enthusiastic about these data and encouraged by the clinical outcomes announced today,” said David Kendall, MD, Chief Medical Officer, Zealand Pharma.¹ “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.”

References:

1. Boehringer Ingelheim. Boehringer Ingelheim and Zealand Pharma announce phase II trial showed 14.9% weight loss in people living with obesity or overweight. Boehringer Ingelheim. May 10, 2023. Accessed May 10, 2023. https://www.boehringer-ingelheim.com/phase-ll-trial-results-in-obesity-or-overweight.
2. A study to test whether different doses of Bi 456906 help people with overweight or obesity to lose weight - full text view. Full Text View - ClinicalTrials.gov. Accessed May 10, 2023. https://clinicaltrials.gov/ct2/show/NCT04667377.
3. Campbell P. Surmount-1: Tirzepatide provides significant, sustained weight loss in obesity. HCP Live. June 4, 2022. Accessed May 10, 2023. https://www.hcplive.com/view/surmount-1-tirzepatide-provides-significant-sustained-weight-loss-in-obesity.