Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, announces that results of a phase 1 clinical trial of IBI362, a glucagon-like petide-1 (GLP-1) and glucagon receptor dual agonist in overweight or obese Chinese participants are presented in an e-poster at the American Diabetes Association 81st Scientific Sessions.
This randomized, double-blind, placebo-controlled multiple-ascending-dose study evaluated the safety, tolerability and pharmacokinetics/pharmacodynamics characteristics of IBI362 in overweight or obese Chinese participants. Twelve participants in each of the three cohorts were randomized 2:1 to receive 1.0-2.0-3.0 mg (cohort 1), 1.5-3.0-4.5 mg (cohort 2) or 2.0-4.0-6.0 mg (cohort 3) IBI362 or placebo for 12 weeks. IBI362 was well tolerated and showed a favorable safety profile. No adverse event leading to dose interruption or dose reduction of the study drug was reported. No participant discontinued the study due to a safety reason. No serious adverse event, no hypoglycemic event and no pancreatitis was reported. Gastrointestinal adverse events and decreased appetite were the most common adverse events. At week 12, reductions in mean body weight from baseline were 3.80 kg (4.81%), 5.77 kg (6.40%) and 5.12 kg (6.05%) for participants receiving IBI362 in cohort 1, 2 and 3, respectively, compared with a 0.37 kg (0.60%) increase in participants receiving placebo (least square means using mixed effect model for repeated measures). Meanwhile, waist circumference, body mass index, blood pressure and lipid profile were also improved in participants receiving IBI362.
"Obesity is a grave public health threat with progressive increase in incidence. However, there is still a lack of effective therapeutic drugs for obese and overweight patients worldwide, which poses a great and unmet medical need. IBI362 has shown good safety, robust weight loss efficacy and multiple benefits in metabolic profile in the phase 1 clinical study, and the preliminary clinical results are very encouraging. We hope that IBI362, as a new generation of GLP-1 and glucagon receptor dual agonists, will show more inspiring results in the subsequent phase 2 clinical studies in subjects with overweight or obesity." said the Professor Linong Ji from Peking University People's Hospital and principal investigator of this study.
"IBI362 is a global innovative drug candidate. As an OXM analog, IBI362 can confer dual benefits of appetite suppression and energy expenditure through the activation of GLP-1receptor (GLP-1R) and glucagon receptor. Compared with traditional GLP-1 receptor agonists, IBI362 may not only achieve higher weight loss, but also improve the overall metabolic situation including fatty liver disease and lipid metabolism in overweight or obese people. These results suggest that IBI362 may be superior to currently available GLP-1R mono agonists for weight loss in obesity, underlining the potential benefits of targeting multiple receptors in improving metabolic disorders." said Dr. Lei Qian, Executive Director of Medical Sciences and Strategies of Special Diseases of Innovent.
About Obesity
China has the largest obese population in the world, which shows a gradually increasing trend. Obesity can lead to a range of complications or related diseases that impact life expectancy or lead to a decrease in quality of life. In more severely obese patients, the incidence and mortality of cardiovascular disease, diabetes, and certain tumors increase significantly. Obesity is a chronic disease that requires long-term management, and there i...
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