Innovent Biologics has reported that its Phase ll trial of a higher dose of 9mg mazdutide (IBI362) to treat Chinese adults with obesity achieved the 24-week primary endpoint.
A total of 80 subjects with obesity having body mass index (BMI) ≥30.0kg/m² are enrolled in the placebo-controlled, randomised, double-blind study.
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They were randomised into a 3:1 ratio to receive either mazdutide 9mg or a placebo once a week for 24 weeks.
Percent change in body weight from baseline versus placebo after treatment for 24 weeks is the primary endpoint of the study.
The mazdutide 9mg regimen demonstrated superior body weight loss in the subjects. The mean per cent change in body weight from baseline versus placebo was -15.4%, after 24 weeks of treatment.
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Secondary and exploratory endpoints will be disclosed at the end, as the study is still in progress.
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By GlobalDataPeking University People’s Hospital’s professor Linong Ji is the principal investigator of the Phase ll study.
Ji said: “There are about 160 million obese people across China (BMI ≥ 28.0kg/m²), of which approximately ten million are with moderate and severe obesity (BMI ≥ 32.5kg/m²).
“The risk of cardiovascular and cerebrovascular diseases for these patients is extremely high, and the quality of daily life and mental health of these patients are significantly affected.
“This study also fills the gap in the clinical research of drug treatment of patients with severe obesity in Chinese and even East Asian populations. I am hopeful that mazdutide 9mg will also show satisfactory results in future Phase III studies.”
The company also intends to extend the study treatment to 48 weeks duration.
Innovent Biologics Clinical Development vice-president Dr Lei Qian said: “I am confident that the longer treatment will bring more weight loss efficacy. In addition, we will advance the Phase III clinical study of mazdutide 9mg in due course, and strive to provide a drug treatment option that can potentially offer a treatment option where today the only highly effective option is bariatric surgery.”
