Novel Treatment Achieves Up to 14.9% Weight Loss After 46 Weeks

Patients administered BI 456906, a novel dual glucagon/GLP-1 receptor agonist developed by Boehringer Ingelheim and Zealand Pharma, experienced up to 14.9% weight loss after 46 weeks when using the planned maintenance dose.¹

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The phase 2 clinical trial (NCT04667377) evaluated the effect of different doses of BI 456906 for individuals living with obesity or overweight without type 2 diabetes. Investigators found that BI 456906 met the primary endpoint.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,” Carinne Brouillon, PharmD, head of Human Pharma at Boehringer Ingelheim, said in a press release.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 health care solutions.”

The phase 2 trial was a randomized, parallel group, dose-finding study of BI 456906, which was subcutaneously administered to individuals living with overweight or obesity, compared to a placebo. The trial included 20 weeks of dose escalation and 26 weeks of maintenance.¹

BI 456906 activates the GLP-1 and glucagon receptors that help to control metabolic function. The drug has the potential to be a new treatment that can offer clinically relevant benefits, according to the study investigators.¹

The results, including an analysis of the actual maintenance dose that indicated even greater weight loss, will be presented at the 2023 American Diabetes Association’s 83rd Scientific Sessions in San Diego, California.¹ The full data remain under embargo until presented at the conference.¹

Additionally, the novel drug is being evaluated in a phase 2 study (NCT04771273) for adults with nonalcoholic steatohepatitis (NASH) and liver fibrosis. The companies expect the trial to be complete in the fourth quarter of 2023.¹

BI 456906 has received fast track designation from the FDA for adults with NASH.¹

According to the CDC, from 2017 to March 2020, obesity prevalence was 41.9% in the United States, which increased from 30.5% from 1999 to 2000.2 During the same time period, the prevalence of severe obesity also increased from 4.7% to 9.2%, according to the CDC.²

The prevalence of obesity was approximately 39.8% for those aged 20 to 39 years, 44.3% for those aged 40 to 59 years, and 41.5% for those aged 60 years and older.²

Obesity has been related to conditions such as cardiovascular disease, stroke, type 2 diabetes, and certain types of cancer. In the United States alone, the estimated annual medical cost of obesity was approximately $173 billion in 2019.²

Additionally, medical costs for adults with obesity were approximately $1861 higher than medical costs for those of a healthy weight, according to the CDC.²

References

1. Boehringer Ingelheim and Zealand Pharma announce phase II trial showed 14.9% weight loss in people living with obesity or overweight. News release. Boehringer Ingelheim. May 10, 2023. Accessed May 11, 2023. https://www.boehringer-ingelheim.com/phase-ll-trial-results-in-obesity-or-overweight

2. Centers for Disease Control and Prevention. Adult Obesity Facts. Overweight & Obesity. Updated May 17, 2022. Accessed May 11, 2023. https://www.cdc.gov/obesity/data/adult.html