The first participant has been successfully dosed in Innovent Biologics’ Phase 3 clinical trial (GLORY-2) of higher dose 9mg mazdutide, a glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with obesity. This is also the fourth large-scale phase 3 clinical study of mazdutide.
GLORY-2 plans to enrol 450 subjects and randomize to receive mazdutide 9mg treatment or placebo. The primary endpoints include the percentage change in body weight from baseline to week 60 and the proportion of subjects with 5% or more body weight loss from baseline at week 60.
The Phase 2 study conducted in Chinese people with obesity with a BMI ≥ 30 kg/m2 (NCT04904913) showed that after 48 weeks of treatment, mazdutide 9mg achieved 18.6% placebo-adjusted mean percent reduction in body weight.
"Accumulated evidence showed that Chinese people generally have higher percentages of body fat and higher rates of cardiovascular risk factors and all-cause mortality than western population at given BMI levels, therefore overweight and obesity in adults in China are defined with lower BMI cutoffs (overweight cutoff BMI 24 kg/m2, obesity cutoff BMI 28 kg/m2). The number of people with obesity with a BMI over 30 kg/m2 in China is huge and still increasing yearly,” said Professor Linong Ji, the principal investigator of the study, Peking University People's Hospital. “This subgroup of people with obesity, bear a greater burden of cardiovascular and metabolic diseases. They require special attention in clinical weight management and early prevention and treatment of metabolic syndrome, whereas the effective drug treatment options are limited. The mazdutide 9 mg Phase 2 study in Chinese people with obesity with a BMI ≥30 kg/m2 demonstrated strong weight loss efficacy, multiple cardiovascular metabolism improvements as well as a good safety profile.”
Furthermore, mazdutide reduced waist circumference, blood pressure, lipids, serum uric acid, transaminase and liver fat, bringing multiple metabolic benefits to the subjects. Mazdutide was well tolerated and the overall safety profile was similar to other GLP-1 class drugs, with no new safety signals observed.
"Different dosage regimens of mazdutide are suitable for different groups of people with obesity. 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,” added Dr Lei Qian, Vice President of Clinical Development at Innovent. “In addition, mazdutide 9mg has simple titration steps and a good safety profile. 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."