Boehringer Ingelheim and Gubra announced the launch of the Phase 1 study (NCT06352437) of BI 3034701, a long-acting triple agonist peptide with a potential to become a next-generation and first-in-class obesity treatment. More than 1 billion people worldwide live with obesity, and numbers are continuing to rise. Estimations show that by 2035, 24% of the entire world population will be affected by this disease.

Obesity is a major risk factor for other cardiovascular, renal, and metabolic (CRM) diseases as well as for several types of cancer, which collectively are a leading cause of death worldwide. With the progression of BI 3034701, Boehringer Ingelheim further expands its pipeline of patient-centric solutions beyond weight loss for people living with obesity to achieve CRM health gain. BI 3034701 was developed together with Gubra involving licensed IP from Gubra, with Boehringer solely responsible for further development and commercialization globally.

The study is the second project in the partnership with Gubra to advance to the clinic, following BI 1820237, for which Phase 1 clinical results were announced in 2023. The Phase 1, first-in-human, randomized, placebo-controlled trial, will assess safety, tolerability, and pharmacokinetics of the drug candidate (BI 3034701). The trial has 2 parts.

Part A is open to healthy men between 18 and 55 years of age. Part B is open to people between 18 and 65 years of age with overweight or obesity who are otherwise healthy. Participants get different doses of BI 3034701 or placebo as an injection under the skin.

In Part A, every participant gets a single dose. In Part B, every participant gets several doses of BI 3034701 and placebo. In this study, BI 3034701 is given to humans for the first time.

The trial with an estimated 124. participants is expected to be completed in the second half of 2025. Additional information about the Phase 1 trial is available via ClinicalTrials.gov (NCT063524 37).

The initiation of the phase 1 trial will release a milestone payment to Gubra.