China-based Innovent Biologics, Inc. (HKG: 1801) has announced that the first patient has been dosed in the multi-center, randomized, double-blind, placebo-controlled Phase III DREAMS-1 study for its mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist. The drug is being assessed for safety and efficacy in treating Chinese patients with type 2 diabetes who have insufficient glucose control through diet and exercise.
Study Design and Enrollment
The Phase III DREAMS-1 study aims to enroll approximately 300 subjects who will be randomly assigned to receive mazdutide in 4.0mg or 6.0mg groups, or placebo. The study treatment period is 48 weeks, comprising 24 weeks of double-blind treatment followed by a 24-week study expansion. The primary endpoint is the change in glycosylated hemoglobin (HbA1c) levels from baseline at the 24th week.
Mechanism and Development
Mazdutide, also known as OXM3 or LY3305677, is a long-acting synthetic peptide related to mammalian oxyntomodulin (OXM). The drug uses a fatty acid side chain to prolong its duration of action, allowing for once-weekly administration. Mazdutide is designed to activate both GLP-1 and glucagon receptors in humans, which is expected to improve glucose tolerance and induce weight loss, mimicking the effects of endogenous oxyntomodulin.
Innovent previously entered into a licensing deal with Eli Lilly and Company (Lilly) for the development and potential commercialization of mazdutide in China. The drug initiated a Phase III study in overweight or obese patients in November of last year, further expanding its clinical development program.
Future Outlook
The initiation of the Phase III DREAMS-1 study for mazdutide marks a significant milestone in Innovent Biologics’ pipeline. With its dual agonist mechanism and demonstrated potential in improving glucose control and weight management, mazdutide is poised to address significant unmet needs in the treatment of type 2 diabetes. Innovent’s ongoing clinical trials and strategic partnerships underscore its commitment to advancing innovative therapies in metabolic diseases.-Fineline Info & Tech
