Boehringer Ingelheim has partnered with Gubra, a specialised pre-clinical contract research services provider, to launch Phase 1 clinical trials for BI 3034701.

BI 3034701 is a novel long-acting peptide triple agonist with the potential to advance obesity treatment as a next-generation, first-in-class therapy.

The obesity drug, developed in collaboration with Denmark-based Gubra, incorporates licensed IP from the contract research services provider.

In the deal, Boehringer Ingelheim leads subsequent global development and commercialisation efforts.

The study marks the second clinical project in partnership with Gubra, following BI 1820237, whose Phase 1 clinical findings were announced in 2023.

The first-in-human, randomised, placebo-controlled Phase 1 trial aims to evaluate the safety, tolerability, and pharmacokinetics of BI 3034701.

Its Part A involves healthy men aged 18 to 55 years who will receive single doses of BI 3034701 or a placebo via subcutaneous injection.

Besides, Part B includes individuals aged 18 to 65 years with overweight or obese and in overall good health, receiving multiple doses of obesity therapy or placebo.

The trial marks the first time administration of BI 3034701 to humans. It will enroll around 124 participants and the study is projected for completion in the latter half of 2025.

Boehringer Ingelheim cardiometabolic diseases research senior vice president and global head Søren Tullin said: “Although early stage this is another step in our comprehensive strategy to improve the quality and length of lives of people living with interconnected cardiovascular, renal and metabolic diseases.

“BI 3034701 is the second out of several joint R&D programs with Gubra advancing into the clinic.” 

The latest development will advance Boehringer Ingelheim’s portfolio of patient-centric solutions beyond weight loss for people with obesity to achieve CRM health gain.  

Nasdaq Copenhagen-listed Gubra specialises in peptide-based drug discovery for metabolic and fibrotic diseases.

Gubra CEO Henrik Blou said: “We are very excited to see BI 3034701 now moving into phase 1. The global prevalence of obesity is increasing, and innovative treatments are indeed needed to tackle this complex, chronic disease.

“This triple agonist is a drug candidate targeting receptors known to induce weight loss and has a potential to become a next-generation and first-in-class treatment for millions worldwide.”