The double-blinded, randomised, placebo-controlled trial will assess the safety and efficacy of mazdutide in subjects who are overweight or obese.
Nearly 80 subjects will be enrolled and categorised into a 3:1 ratio to receive 9mg mazdutide or a placebo for a period of 24 weeks.
The percent variation in body weight from baseline at week 24 will be the primary endpoint of the trial.
According to the findings reported in June this year from the low dose cohorts of 3mg, 4.5mg, and 6mg mazdutide, the primary endpoint was met.
These doses offered substantial efficacy on body weight loss versus a placebo at week 24 in a dose-dependent manner and offered various cardio-metabolic benefits to the trial subjects.
The therapy was also found to be well tolerated and the complete safety profile was in line with other drugs belonging to the same class.
In a Phase Ib trial, mazdutide titrated to 9mg showed to have a robust safety profile and offered body weight loss of 11.7% at 12 weeks.
Based on these results, the company decided to assess a higher 9mg dose of mazdutide in obese patients in China.
Mazdutid is a glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist.
It is a long-acting synthetic peptide linked to mammalian oxyntomodulin (OXM).
OXM leverages a fatty acid side chain to extend the action time and permit once-a-week dosing.
Innovent Clinical Development vice-president Dr Lei Qian said: “In the Phase II study in Chinese participants [who are] overweight or [obese], low-dose mazdutide showed robust efficacy on body weight loss and multiple improvement in metabolic parameters, reflecting the best-in-class potential of mazdutide among GLP-1 receptor agonists and co-agonists.
“To further extend its clinical utility, we will continue to explore the clinical benefit of mazdutide 9.0mg in adults with obesity (BMI ≥ 30kg/m²).”
In August this year, the company dosed the first subject in the Phase I trial of IBI324 in diabetic macular oedema patients.