Boehringer Ingelheim has partnered with Gubra, a specialized biotech company and preclinical CRO that specializes in peptide-based drug discovery for metabolic diseases, to launch phase 1 clinical trials for BI 3034701. This drug candidate is a long-acting peptide designed to target three different receptors associated with weight loss, offering a potential new avenue for tackling obesity.
Amidst a growing obesity epidemic, therapeutic demand surges
Obesity is a growing global health concern, impacting some 1 billion people globally. By 2035, the condition could affect nearly one-quarter of the global population, according to World Obesity. Against that backdrop, GLP-1 (glucagon-like peptide-1) receptor agonists have exploded in popularity in recent years, propelling the valuation of companies like Novo Nordisk and Eli Lilly.
In contrast to the GLP-1 receptor agonist semaglutide from Novo Nordisk and the dual GLP-1/GIP receptor agonist tirzepatide from Eli Lilly, BI 3034701 takes a novel approach by targeting three receptors.
Phase 1 trial design for BI 3034701
The Phase 1 trial (NCT06352437) is designed to assess the safety, tolerability, and pharmacokinetics of BI 3034701. It consists of two parts:
- Part A: Focuses on healthy men aged 18-55, evaluating the drug’s effects in a single-dose regimen.
- Part B: Includes both men and women aged 18-65 who have overweight or obesity, examining multiple rising doses of BI 3034701.
Participants in both parts will receive BI 3034701 or a placebo via subcutaneous injection. The trial, involving an estimated 124 participants, is slated to wrap up in the second half of 2025.
Optimism for BI 3034701’s potential
In a press release, both companies expressed optimism about the drug’s potential. Søren Tullin, Senior Vice President and Global Head of Cardiometabolic Diseases Research at Boehringer Ingelheim, highlighted its alignment with the company’s strategy to improve the lives of people with interconnected cardiometabolic conditions. Gubra CEO Henrik Blou noted that BI 3034701 “has the potential to become a next-generation and first-in-class treatment for millions world-wide” owing to its triple-agonist mechanism targeting weight loss receptors.
Second collaboration between Boehringer Ingelheim and Gubra
This trial represents the second collaboration between Boehringer Ingelheim and Gubra to reach phase 1. Their previous joint project, BI 1820237, a novel long-acting neuropeptide Y receptor type 2 (NPY2) agonist, reported Phase 1 results in 2023. That study found no unexpected safety concerns and reported positive effects on energy intake and gastric emptying.
Filed Under: clinical trials, Metabolic disease/endicrinology
