Innovent Biologics’ dual GLP-1/glucagon receptor agonist mazdutide is also being developed for chronic weight management. China’s regulator accepted Innovent’s drug application for this indication in February 2024.
Innovent Biologics on Monday announced that its investigational dual GLP-1/glucagon receptor agonist mazdutide cleared the Phase III DREAMS-1 study in China, leading to significant blood sugar control in adults with type 2 diabetes.
At the follow-up at 24 weeks, patients treated with the 4-mg dose of mazdutide saw a 1.57% reduction in HbA1c, while the 6-mg dose elicited a 2.15% drop. In the placebo arm, HbA1c only decreased 0.14% from baseline. The treatment effect for both mazdutide doses reached statistical significance, with p-values less than 0.0001.
In addition, the reductions in HbA1c were maintained through 48 weeks, according to Innovent.
Mazdutide also met its secondary efficacy endpoints, eliciting significantly greater weight loss at 24 weeks versus placebo. The percentage of patients with HbA1c levels below 7% and that lost at least 5% of their body weight was also significantly higher in both mazdutide-treated arms than in placebo comparators.
In terms of safety, mazdutide was well-tolerated with most toxicities being gastrointestinal in nature, the majority of which were mild or moderate. Cases of hypoglycemia developed relatively infrequently and were largely grade 1 in severity. There were no severe cases of hypoglyecemia.
With these data, Innovent is planning to file a new drug application for mazdutide in type 2 diabetes (T2D) with the National Medical Products Administration (NMPA) of China “in the near term,” according to the company.
Lei Qian, vice president of clinical development at Innovent, in a statement said that DREAMS-1 “provided high-quality, compelling evidence for T2D treatment in China,” especially in patients who had not undergone prior treatments and whose blood sugar levels were “inadequately controlled” through diet and exercise. Innovent will present more detailed data and analyses from DREAMS-1 at an upcoming medical congress or publish these in an academic journal, Qian said.
Originally developed and discovered by Eli Lilly, mazdutide is an analog of the mammalian oxyntomodulin hormone and works by activating both the GLP-1 and glucagon receptors. This mechanism of action allows mazdutide to boost insulin secretion, cut blood sugar levels and promote weight loss.
In August 2019, Innovent entered into a licensing agreement with Lilly to develop and potentially commercialize mazdutide in China. At the time, the biotech touted mazdutide as a “potential best-in-class” type 2 diabetes (T2D) treatment.
In addition to T2D, Innovent is also developing mazdutide for chronic weight management. In February 2024, the NMPA accepted the biotech’s drug application in this indication, backed by data from the Phase III GLORY-1 study, which demonstrated that both 4-mg and 6-mg doses of mazdutide significantly cut body weight and improved related cardiometabolic endpoints versus placebo.
