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Beijing, China — Recently, Gan & Lee Pharmaceuticals (Stock Code: 603087.SH) announced that their independently developed long-acting GLP-1 receptor agonist (GLP-1 RA) drug, GZR18, has completed the first subject dosing for two Phase IIb clinical trials in China. These trials are aimed at evaluating the efficacy and safety of GZR18 in adult patients with Type 2 Diabetes Mellitus (T2DM) and in patients with obese/overweight.
The multi-center, randomized, controlled Phase IIb clinical studies initiated by Gan & Lee aim to assess the efficacy and safety of GZR18 injections in Chinese adult patients with T2DM and in patients with obese/overweight, respectively. The trials will involve multiple dosing and plan to enroll 225 adult T2DM patients and 260 obese/overweight participants.
In recent years, chronic non-communicable diseases such as cardiovascular diseases, diabetes, and certain cancers have accounted for nearly 90% of total deaths in China, posing a significant public health challenge both nationally and globally. Overweight and obesity are among the primary risk factors for these diseases1. T2DM, one of the most prevalent chronic diseases, affects approximately 11.9% of adults in China, with obesity and overweight significantly increasing the risk2.
T2DM is caused by a combination of declining β-cell function, insulin action defects, and abnormal secretion of glucagon-like peptide. GLP-1 RA, a new class of antidiabetic drugs in the T2DM treatment landscape, can significantly address some of the key pathophysiological defects of T2DM. They offer benefits beyond glucose control, such as reducing cardiovascular disease risk, improving atherosclerosis, weight reduction, lowering systolic blood pressure, and improving lipid profiles3. With the increasing clinical application of GLP-1RA, its hypoglycemic effects, weight loss benefits, and safety have been widely recognized by domestic and international guidelines4.
The initiation of the Phase II clinical trial of GZR18 in China will accelerate the research and development process of GZR18, potentially providing patients with more safe and effective drug treatment options domestically.
GZR18, developed by Gan & Lee, is a GLP-1 receptor agonist intended for the treatment of T2DM in adults and for weight management in obese/overweight individuals. Preclinical data suggests that GZR18 has potential benefits in reducing blood glucose levels and weight. Some clinical studies have confirmed its efficacy in these areas, and it has a good safety profile. Currently, the global development of GZR18 has entered the Phase II clinical research stage.
1. Wang YF, Sun MX, Yang YX, et al. China blue paper on obesity prevention and control[M]. Beijing: Peking University Medical Press, 2019.
2. Chinese Diabetes Society. Guidelines for the prevention and treatment of type 2 diabetes in China (2020 edition)[J]. Chinese Journal of Diabetes Mellitus,2021,13(4):317-411.
3. Pedrosa, Maurício Reis et al. “GLP-1 Agonist to Treat Obesity and Prevent Cardiovascular Disease: What Have We Achieved so Far?.” Current atherosclerosis reports vol. 24,11 (2022): 867-884. doi:10.1007/s11883-022-01062-2
4. Guangdong Pharmaceutical Association. Pharmaceutical expert consensus on the clinical application of glucagon-like peptide-1 receptor agonists (GLP-1RA)[J/OL]. Pharmacy Today:1-38 [2023-04-21]. http://kns.cnki.net/kcms/detail/44.1650.R.20230421.0935.004.html.
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