Innovent announces that mazdutide (IBI362) completed the dosing of the first subject in the China Phase III clinical study GLORY-1

Innovent Biopharmaceutical Group (HKEx stock code: 01801), a biopharmaceutical company dedicated to the development, production and marketing of innovative drugs for the treatment of major diseases such as oncology, autoimmunity, metabolism, ophthalmology, etc.
, announced: glucagon-like peptide-1 receptor (GLP-1R) / glucagon receptor, GCGR) double agonist mazdutide (R&D code: IBI362) was administered in a randomized, double-blind, placebo-controlled phase III clinical study (GLORY-1) in overweight or obese subjects in China
.

This study is a randomized, double-blind, placebo-controlled phase III clinical study (NCT05607680) to evaluate the efficacy and safety of mazdutide in overweight or obese subjects in China, and is also the first registered clinical study in obesity indications among GLP-1R/GCGR dual agonists in the world, and is expected to take the lead in achieving new breakthroughs
.
The study planned to include 600 participants randomized 1:1:1 to mazdutide 4 mg, mazdutide 6 mg, or placebo for a total of 48 weeks
.
The primary endpoints of the study were the percentage change in participants' weight from baseline at week 32 and the proportion
of participants with a ≥5% decrease in weight from baseline.
Previously, the results of a randomized, double-blind, placebo-controlled phase II clinical study (ClinicalTrials.
gov, NCT04904913) in overweight or obese subjects in China showed that after 24 weeks of administration, the weight change relative to baseline in the mazdutide 6 mg group was -11.
57%.

In addition, mazdutide can also significantly reduce the subject's waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes and liver fat, etc.
, bringing multiple metabolic benefits to overweight or obese subjects, showing best-in-class potential
.
In terms of safety, mazdutide is well tolerated, and the overall safety profile is similar to that of similar
drugs.
This phase III clinical study will further validate the efficacy and safety
of long-term administration of mazdutide.

Professor Ji Linong, the principal investigator of the study, said: "Obesity is associated with a variety of chronic noncommunicable diseases and is listed as one of the important risk factors affecting the burden of
disease in all mankind.
The number and growth rate of obesity in China rank first in the world, and effective and safe weight-loss drugs are urgently needed to meet the needs of
clinical disease prevention and treatment.
The results of the phase II study show that mazdutide, as a GLP-1R/GCGR dual agonist, has significant weight loss efficacy and comprehensive metabolic improvement effect in overweight or obese people, indicating that it has the potential to become the best drug in its class worldwide, it is worth pointing out that the population of subjects included in the mazdutide registration clinical study is significantly different from the main subject population of similar weight loss product registration studies in the international study that has published the results of the study.
The latter are mainly dominated by larger Western Caucasian populations, and Chinese groups tend to have limited inclusion; The clinical study of mazdutide will provide large-scale and more representative clinical evidence of Chinese groups, which will provide more clinical guidance for the treatment of obesity in Chinese groups
.
I am very much looking forward to the results of mazdutide's Phase III clinical study, as this drug has the potential to become truly the best innovative drug of its kind in the world
.
" "

Dr.
Lei Qian, Vice President of Clinical Development, Innovent Biopharmaceutical Group, said, "The Phase II study results of mazdutide in overweight or obese subjects in China fully demonstrate the great application value of GLP-1R/GCGR dual agonists, and further demonstrate the potential
of mazdutide to be best-in-class.
These results provide a solid foundation for conducting Phase III clinical studies, and we are confident that we will see further manifestations of mazdutide's excellent efficacy in Phase III and continue to observe efficacy and safety
for a longer period of time after the clinical endpoint is reached.
" Mazidutide is also the first molecule in the global GLP-1R/GCGR dual agonist to enter the obesity indication registration study stage, and the GLORY-1 study is a milestone
.
Mazutide's overall development plan and key registration study design in China have been communicated with regulators and received positive feedback, based on this, we will continue to bring Mazdutide to doctors and patients as quickly as possible through efficient and solid clinical research and scientific development
.
Expecting the success of mazdutide in the Phase III clinical study, we strive to provide friendlier, more effective and safer clinical drug options
for overweight and obese people at an early date.
" "

About obesity

China is the country with the largest obesity population in the world, and it is showing a gradual upward trend
.
Obesity can lead to a range of complications or related diseases that affect life expectancy or lead to a decline
in quality of life.
In more severe obesity, the incidence and mortality of cardiovascular disease, diabetes and certain tumors have increased
significantly.
Obesity is a chronic disease that requires long-term treatment, and there is currently a lack of long-term, effective and safe treatment
.
Lifestyle intervention is the first choice and basic treatment for overweight or obese people, but there are still a considerable number of patients who cannot achieve the desired weight loss goals for various reasons and need to use drugs to assist weight
loss.
Traditional weight loss drugs have limited effect on weight loss and have safety concerns
.

About Mazdutide (IBI362)

Mazdutide (IBI362) is an innovative gastrine regulator compound (OXM3) jointly promoted by Innovent Biologics and Eli Lilly with the best potential
in its class.
As a long-acting synthetic peptide similar to mammalian gastrine regulator, mazdutide utilizes fatty acyl side chains to prolong the duration of action, allowing weekly administration
.
The effect of mazdutide is thought to be mediated by the binding and activation of GLP-1R and GCGR, and has a similar mechanism of action to OXM, so it is expected to improve glucose tolerance and reduce body weight
.
In addition to GLP-1R agonist effects such as promoting insulin secretion, lowering blood sugar and reducing weight, mazdutide may also have effects such as increasing energy expenditure and improving liver fat metabolism through GCGR activation
.