Innovent Biologics : Second Phase 3 Trial Of Mazdutide In Type 2 Diabetes Meets Study Endpoints

(RTTNews) – Innovent Biologics Inc. said that the Phase 3 clinical trial (DREAMS-1) of mazdutide, a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with type 2 diabetes (T2D) met the primary endpoint and all key secondary endpoints.

Another Phase 3 clinical trial DREAMS-2 has previously met the study endpoints, in which mazdutide showed superiority compared with dulaglutide for glycaemic control, as well as weight loss and multiple cardiometabolic benefits in T2D patients.

Innovent plans to submit a new drug application (NDA) of mazdutide for T2D treatment to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) in the near term, following the acceptance of its first NDA for chronic weight management in February 2024.

At week 24, the reduction from baseline in HbA1c in both the mazdutide 4 mg and 6 mg groups (2.15%) was superior to the placebo. The efficacy of HbA1c reduction in patients treated with mazdutide was sustained through week 48, the company said.

At week 24, mazdutide showed significantly higher weight reduction compared with placebo. The proportion of patients who achieved HbA1c less than 7.0%, weight reduction greater than or equal to 5%, and dual targets of HbA1c less than 7% and weight reduction greater than or equal to 5% were significantly higher in mazdutide groups than placebo. At week 48, patients treated with mazdutide 6mg showed weight loss of 9.6% from baseline.

Besides HbA1c and weight loss, mazdutide also reduced cardiovascular metabolic indicators including postprandial blood glucose, waist circumference, blood pressure, blood lipids, transaminases, and urinary albumin-to-creatinine ratio.

Overall safety and tolerability were favorable and consistent with previous clinical studies of mazdutide. The most commonly reported adverse events were gastrointestinal adverse events, mostly mild to moderate. No new safety signals were identified.

The incidence of hypoglycemia events was low, most of which were Grade 1 hypoglycemia. No severe hypoglycemia events were reported.

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