The dulaglutide-controlled, multicentre, randomised Phase III clinical trial will compare the safety and efficacy of mazdutide and dulaglutide in type 2 diabetes patients who do not have sufficient glycemic control with metformin monotherapy, or metformin combination therapy with sodium-glucose cotransporter 2 (SGLT2) inhibitors or sulfonylureas.
Nearly 720 participants will be enrolled and randomised in a 1:1:1 ratio and given either mazdutide 4mg, mazdutide 6mg, or dulaglutide 1.5mg for a period of 28 weeks.
The change in glycated haemoglobin (HbA1c) levels from baseline to week 28 will be the trial’s primary endpoint.
Mazdutide was found to be well tolerated and its overall safety profile was similar to other GLP-1 class drugs in a Phase II clinical study.
With mazdutide, the mean change in HbA1c was up to -1.67% and body weight was up to -7.11% from baseline to week 20.
It also reduced the levels of blood lipids and liver enzymes, reduced blood pressure, and provided metabolic benefits to the participants in the trial.
Innovent Clinical Development vice-president Dr Lei Qian said: “The results of the Phase II study of mazdutide in Chinese patients with type 2 diabetes fully demonstrate the efficacy and good safety of GLP-1R/GCGR dual agonists, showing potential clinical value.
“These results lay a solid foundation for the Phase III study. We look forward to expanded evidence of mazdutide’s efficacy and safety in the Chinese population.”
In a separate development, the company has dosed the first participant in the Phase III DREAMS-1 clinical trial of mazdutide in type 2 diabetes patients in China.
The placebo-controlled, randomised, multicentre, double-blind Phase III trial will assess mazdutide’s safety and efficacy in type 2 diabetes patients who are inadequately controlling the disease by diet and exercise alone.