Boehringer Ingelheim, Gubra Initiate Phase I Clinical Trial for BI 3034701, a Potential Obesity Treatment
Clinical trial for BI 3034701 is expected to evaluate the safety, tolerability, and pharmacokinetics in healthy men and overweight or obese individuals aged 18-55 years old.
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Boehringer Ingelheim and Gubra have launched a Phase I clinical trial for BI 3034701, a long-acting triple agonist peptide that could potentially become a first-in-class obesity treatment. Developed through collaboration, BI 3034701 involves a licensed IP by Gubra, with Boehringer Ingelheim remaining solely responsible for further development and commercialization globally.1
“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,” says Søren Tullin, SVP, global head, cardiometabolic diseases research, Boehringer Ingelheim, in a press release. “BI 3034701 is the second out of several joint R&D programs with Gubra advancing into the clinic.”
The trial is a first-in-human randomized, placebo-controlled trial, aiming to assess safety, tolerability, and pharmacokinetics of BI 3034701, with an estimated 124 participants expected. There will be two parts of the study, with the first being open to healthy men between 18 and 55 years of age, and the second will consist of people between the same age range that struggle with obesity or are overweight but healthy otherwise. According to the companies, participants will receive a different dose of BI 3034701 or placebo as an injection under the skin. In the first group, participants will receive a single dose while participants in the second group will receive either several doses of BI 3034701 or placebo. It is expected to conclude in the second half of 2025, with Gubra receiving a milestone payment upon initiation of the trial.1
According to the Mayo Clinic, treatment for obesity starts with the goal of losing around 5% to 10% of total weight and then continue from there. However, it may require working with a team of health professionals such as a dietitian, behavioral counselor, or obesity specialist in order to understand and make the appropriate changes to a patient’s eating habits.2
“All weight-loss programs require that you change your eating habits and get more active. The treatment methods that are right for you depend on your weight, your overall health and your willingness to participate in a weight-loss plan,” reports the Mayo Clinic.
Regarding dietary changes, the Mayo Clinic suggests cutting calories, eating larger portions of food with less calories, limiting the intake of certain foods, and replacing meals with diet-based alternatives. Further, exercising consistently and seeking out counseling or support groups that consist of individuals going through the same experience.
Weight-loss medications may be used in combination with diet and exercise but aren’t intended to be a replacement. Common FDA-approved weight loss treatments include Contrave, Ozempic, Wegovy, Saxenda, and Xenical. In other cases, endoscopic procedures or weight-loss surgeries are also possible.2
According to John Hopkins Medicine, the best treatment option is based on the patient’s age, overall health, physical abilities, and medical history, past weight loss efforts, current weight, tolerance to medications, procedures, or therapies, and personal preferences.3
“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 world-wide,” said Henrik Blou, CEO, Gubra, in the press release.
References
1. Boehringer Ingelheim and Gubra announce start of clinical development of a potential first-in-class, triple agonist, obesity treatment. Boehringer Ingelheim. July 1, 2024. Accessed July 3, 2024. https://www.boehringer-ingelheim.com/science-innovation/human-health-innovation/phase-1-start-novel-triple-agonist-obesity-treatment
2. Obesity. Mayo Clinic. Accessed July 3, 2024. https://www.mayoclinic.org/diseases-conditions/obesity/diagnosis-treatment/drc-20375749
3. Medical Treatment for Obesity. John Hopkins Medicine. Accessed July 3, 2024. https://www.hopkinsmedicine.org/health/conditions-and-diseases/obesity/medical-treatment-for-obesity
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