Chinese biopharmaceutical company Innovent has dosed the first subject in its Phase III GLORY-2 clinical trial of mazdutide 9mg (IBI362) in adults with obesity in China.
Mazdutide is a dual agonist of the glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR).
The company aims to enrol 450 participants in the trial, who will be randomly assigned to receive either mazdutide or a placebo.
Percentage variation in body weight until week 60 from baseline and the proportion of participants attaining at least a 5% body weight reduction at the same week from baseline will be the trial’s primary endpoints.
A previous Phase II trial in Chinese participants demonstrated that treatment with 9mg of mazdutide caused an 18.6% placebo-adjusted mean percentage body weight reduction over 48 weeks.
The drug also aided in reducing the circumference of the waist, blood pressure and levels of lipid, serum uric acid, transaminase and liver fat.
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Mazdutide was found to be well-tolerated with a complete safety profile in line with that of various other GLP-1 class drugs, without any new safety concerns reported.
Innovent Clinical Development vice-president Dr Lei Qian said: “Mazdutide 9mg is specifically developed to meet the weight loss needs of people with moderate to severe obesity with a BMI above 30kg/m² in China.
“We are hopeful that mazdutide 9mg will fully demonstrate its powerful efficacy and good safety in the GLORY-2 study and bringing a more ideal drug treatment option to patients with moderate to severe obesity, whose current recommended treatment is bariatric surgery.”
Innovent previously signed an agreement with Eli Lilly and Co to obtain the sole licence for developing and marketing OXM3 (mazdutide) in China.
Four Phase III studies are currently in progress to investigate the drug’s benefits, enrolling patients who are overweight or obese (GLORY-1 and GLORY-2) and have type 2 diabetes (DREAM-1 and DREAM-2) in China.