Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the results of high-dose cohorts in a phase 1 clinical trial of mazdutide (IBI362), a glucagon-like petide-1 (GLP-1) and glucagon receptor dual agonist, in Chinese adults with overweight or obesity are presented as an on-demand poster (ODP014) at ENDO 2022.
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This randomized, double-blind, placebo-controlled multiple-ascending-dose study (ClinicalTrials.gov, NCT04440345) evaluated the safety, tolerability and PK/PD characteristics of mazdutide in Chinese participants with overweight or obesity. Twelve participants in each of the five cohorts were randomized 2:1 to receive subcutaneous 1.0-2.0-3.0 mg (cohort 1), 1.5-3.0-4.5 mg (cohort 2), 2.0-4.0-6.0 mg (cohort 3), 2.5-5.0-7.5-10.0 mg (cohort 4) or 3.0-6.0-9.0 mg (cohort 5) mazdutide or placebo once weekly, with each dose level administered for 4 weeks. Each cohort of participants received administration for 12 weeks in total except that participants in cohort 4 received administration for 16 weeks
population in China exceeded 100 million. Most patients failed to achieve weight loss goals by lifestyle intervention, underlying the urgent need for safe and highly efficacious weight loss treatments. We are delighted to see high-dose mazdutide showed a similar safety profile as low-dose mazdutide, while demonstrated more robust weight loss efficacy, as well as multiple benefits in metabolic parameters. High-dose mazdutide may offer bariatric surgery-equivalent weight loss and potentially provides an encouraging treatment option for patients with severe obesity. Based on the current data and R&D progress, I believe that mazdutide has the full potential to become an innovative anti-obesity drug buster. I am also confident that mazdutide will achieve a great success in the phase III clinical studies scheduled in the second half of this year. I hope that mazdutide can be approved and launched-to-market and benefit patients in the foreseeable future.”
Dr. Lei Qian, Vice President of Clinical Development of Innovent, said “High-dose mazdutide showed favorable safety, tolerability, and robust efficacy on weight loss in Chinese adults with overweight or obesity. Mazdutide is the only molecule that achieve a 12-week weight loss by more than 11.5% among single-agent anti-obesity molecules approved or under development. This result demonstrates the superiority of GLP-1 and glucagon receptor dual agonists over GLP-1 receptor mono-agonists in terms of weight loss efficacy. Meanwhile, this study further validated the multiple metabolic benefits offered by mazdutide to patients with overweight or obesity. We will continue to develop high-dose mazdutide in overweight or obesity and other potential indications and expect more exciting results.”