Innovent Biologics has announced positive results from the Phase III DREAMS-1 clinical trial of mazdutide (IBI362), meeting the primary and key secondary endpoints, for treating type 2 diabetes (T2D) in Chinese patients.
Mazdutide is a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist.
The randomised, double-blind, placebo-controlled study was designed to assess the efficacy and safety of mazdutide in adults with T2D who have inadequate glycemic control through diet and exercise alone.
The trial enrolled 320 participants, who were randomised into a 1: 1: 1 ratio to receive either 4mg or 6mg doses of mazdutide or a placebo in the double-blind period.
Subsequently, those in the placebo group were switched to receive mazdutide 6mg for 24 weeks.
The primary endpoint was the change from baseline in glycated haemoglobin (HbA1c) at week 24.
Both the 4mg and 6mg mazdutide groups showed a significant reduction in HbA1c levels compared to the placebo group, with reductions of 1.57% and 2.15% respectively, versus 0.14% for the placebo group.
Furthermore, mazdutide offered higher weight reduction versus placebo.
Beyond glycemic control, mazdutide also demonstrated weight loss benefits and improvements in various cardiovascular metabolic indicators such as waist circumference, postprandial blood glucose, blood lipids, blood pressure, transaminases and urinary albumin-to-creatinine ratio.
The safety and tolerability profile of mazdutide was favourable and in line with previous clinical studies, with gastrointestinal adverse events being the most commonly reported, mostly of mild to moderate severity.
Following the success of another Phase III trial, DREAMS-2, where mazdutide outperformed dulaglutide in glycemic control and weight loss, Innovent is preparing to submit a new drug application for mazdutide to the National Medical Products Administration's Center for Drug Evaluation in China.
This follows the acceptance of its first NDA for chronic weight management in February 2024.
Innovent Clinical Development vice-president Dr Lei Qian said: “The results of DREAMS-1 provided high-quality, compelling evidence for T2D treatment in China, particularly in previously untreated patients whose blood glucose was inadequately controlled with diet and exercise alone.
“The results of another Phase III study DREAMS-2, involving patients with T2D inadequately controlled by oral antidiabetic drugs (OADs), met the study endpoints in May 2024. Together, the two studies demonstrate mazdutide’s comprehensive efficacy in improving glycemic control, promoting weight loss, and enhancing metabolic outcomes in patients with T2D.”
