Innovent Biologics has announced results from its Phase II trial investigating mazdutide in Chinese patients with type 2 diabetes (T2D).
The drug was able to reduce weight in patients while proving tolerability.
The results, which were published in the American Diabetes Society’s journal Diabetes Care detailed that the randomised, double-blind, placebo-controlled trial was able to effectively control blood glucose levels (HbA1c) and reduce weight after 20 weeks.
Mazdutide showed baseline HbA1c reductions of 1.41% over 20 weeks in patients dosed with 3mg of mazdutide, 1.67% using 4.5mg, and 1.55% with 6mg. The placebo group showed reductions of 1.35%.
In addition, 24% of patients treated with 3mg of mazdutide lost more than 5% of their body weight. In the 4.5mg and 6mg dose cohorts, 37% and 57.1% of patients reported a more than 5% loss in weight, respectively. The trial was conducted at 32 hospitals across China.
The study's corresponding author Wenying Yang said: “The rate of achieving target blood glucose control in Chinese patients with T2D is still low. There is an urgent clinical need for safe, efficacious and innovative medicines to treat diabetes that offer improved patient convenience, weight loss effect, multiple cardiometabolic benefits and low hypoglycaemic risk.”
Lei Qian, vice president of clinical development at Innovent, has said that the registrational Phase III studies, DREAMS-1 and DREAMS-2, investigating mazdutide in Chinese T2D patients are currently underway.
Qian commented: “This Phase II study in Chinese patients with T2D demonstrated mazdutide's differentiated advantage as a dual agonist that not only lowers glucose but also controls weight and brings multiple cardiometabolic benefits for T2D patients.
“Furthermore, the consistently favourable safety profile further validates the good safety and tolerability of this novel molecule as observed in accumulated studies.”
In May, Innovent reported that its Phase ll trial of a higher dose of 9mg mazdutide to treat Chinese adults with obesity achieved the primary endpoints.
Mazdutide is a GLP-1R and GCGR dual agonist. Innovent entered a licensing deal with Eli Lilly to develop and potentially commercialise the drug in China.
GlobalData’s Pharmaceutical Intelligence Centre forecasts sales for mazdutide at around $11m by 2024, with that figure expected to rise to $566m by 2029.
GlobalData is the parent company of Clinical Trials Arena.
