Boehringer Ingelheim and Gubra have initiated a Phase I clinical trial of BI 3034701, a long-acting triple agonist peptide designed to treat obesity.
The randomised, first-in-human, placebo-controlled trial will evaluate the drug's tolerability, safety, and pharmacokinetics and be carried out in two parts.
Part A will involve healthy men aged 18 to 55 years receiving a single drug dose or placebo while Part B will include individuals aged 18 to 65 years who are overweight or obese.
Subjects in Part B will receive multiple doses of either BI 3034701 or a placebo. All treatment doses will be administered via subcutaneous injection.
The trial will have an estimated 124 participants and is expected to be completed in the second half of next year.
The start of the trial will cause a 'milestone' payment to Gubra.
Boehringer Ingelheim is advancing its range of patient-centred offerings by launching the BI 3034701 trial, broadening its efforts beyond weight loss to achieving health benefits for individuals with obesity.
Although the drug was developed in collaboration with Gubra using licensed intellectual property from Gubra, Boehringer is fully responsible for its global development and commercialisation.
This project is the second in the Boehringer-Gubra partnership to reach clinical trials, following BI 1820237, which reported Phase I data last year.
Boehringer Ingelheim cardiometabolic diseases research global head and senior vice-president 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.”
In May this year, Boehringer reported positive data from the HORNBILL Phase I/IIa clinical trial of the humanised monoclonal anti-Sema3A antibody, BI 764524, as a potential treatment for diabetic macular ischaemia.
