Innovent Biologics’ Phase II trial of mazdutide, a potential treatment for type 2 diabetes, showed the drug met its primary endpoint by successfully reducing HbA1c levels.
Preliminary results from Innovent Biologics’ Phase II trial of mazdutide, a potential treatment for type 2 diabetes, showed the drug met its primary endpoint by successfully reducing HbA1c levels versus placebo after 20 weeks of treatment.
Mazdutide was jointly developed by Eli Lilly and Innovent, as part of a licensing deal for OXM3 (the other moniker for mazdutide) in China. Eli Lilly is independently developing the drug outside of China.
The multi-center, double-blind, dulaglutide-controlled study is looking into the safety and efficacy of mazdutide in 252 Chinese patients diagnosed with type 2 diabetes that had not been controlled by lifestyle changes. The participants were given either 3 mg, 4.5 mg or 6 mg of mazdutide, placebo or 1.5 mg dulaglutide via subcutaneous injection once a week for 20 weeks. They all also underwent either a four- or eight-week titration phase.
The drug was also found to be well-tolerated and safe, with no severe hypoglycemia events.
“This result lays a solid foundation for the upcoming Phase III study. It is worth noting that we compared the efficacy of mazdutide with dulaglutide (1.5 mg) in this Phase II study, and obtained encouraging results, reinforcing our strong confidence in mazdutide’s potential,” Dr. Lei Qian, vice president of clinical development at Innovent said in a statement.
Mazdutide is a long-acting, synthetic peptide associated with mammalian oxyntomodulin (OXM), which uses a fatty acid side chain to prolong its duration of action, thus allowing once-weekly dosing. It works by activating the GLP-1 and glucagon receptors in humans, which induces weight loss and enhances glucose tolerance.
“There is an urgent clinical need for efficacious innovative drugs that are also safe, with low hypoglycemic risk, convenient, and can provide cardiovascular benefits...I look forward to the upcoming Phase III study and the potential benefits to patients.” Professor Wenying Yang, the principal investigator of the study from China-Japan Friendship Hospital noted.
Innovent said it will communicate with regulatory authorities and prepare to actively enroll Phase III study participants soon, without providing a specific timeline. Data from the study are still being analyzed and organized for presentation in peer-reviewed journals.
