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Today (September 21), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration showed that the clinical trial application for NNC0519-0130 injection, a Class 1 new drug from Novo Nordisk, has been accepted. According to publicly available information from Novo Nordisk, this is a drug currently under research by the company.A dual-target GIP/GLP-1 receptor agonist administered once weekly via subcutaneous injection is currently in Phase 2 clinical trials internationally for patients with Type 2 diabetes and obesity.. This is the first clinical application of the product in China.
Screenshot source: CDE official website
Public information shows that glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) are hormones that regulate blood sugar.GIP is an incretin that can complement the action of GLP-1 receptor agonists. Studies have shown that GIP reduces food intake and increases energy expenditure, thereby reducing body weight. When combined with GLP-1 receptor agonists, it may have a greater impact on glucose levels and body weight.Dual receptor agonist of GIP and GLP-1YesIntegrating the effects of these two incretins into a single molecule to achieve glucose-lowering and weight-reducing effects.
According to the pipeline information on Novo Nordisk's official website, the company plans to develop this GIP/GLP-1 receptor agonist for type 2 diabetes and weight loss.ClinicalTrialsOfficial website, Novo Nordisk has previously launched in the United States, Japan, Australia, South Korea, and other places.NNC0519-0130 Injection: Multiple Phase 1 andPhase 2 clinical study, planned to evaluate the pharmacokinetics, safety, and efficacy of NN0519-0130 in healthy individuals and those with type 2 diabetes and obesity.Among them, there are two international multicenterPhase 2Clinical studies have now been initiated, respectively:- OneComparison of Six Different Doses of NN0519-0130 Against the Control DrugHypoglycemic Effect in Type 2 Diabetes PatientsThe study, which is planned to last approximately 40 weeks, aims to enroll 288 participants internationally;
- A Comparison of Six Different Doses of NN0519-0130 Against a Control DrugHelp Overweight People Lose WeightThe study, which is planned to last approximately 42 weeks, aims to enroll 355 participants internationally.
This timeNNC0519-0130Filing for clinical trials in China means that it is expected to initiate clinical research in China in the near future.Notably, according to information on Novo Nordisk's official website, in addition to this once-weekly GIP/GLP-1 dual-target agonist, Novo Nordisk has also developedOnce-Monthly (OM) Subcutaneous Injection of GIP/GLP-1 Dual Agonist(Research and development code: NN9650) is expected to further enhance the convenience of administration. The phase 1 clinical trial results for this product are anticipated to be available in 2025.
References:
[1] Website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Sep 21, 2024, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c
[2] Novo Nordisk Official Website. From https://www.novonordisk.com/content/dam/nncorp/global/en/investors/irmaterial/cmd/2024/P2-Research-and-Early-Development.pdf
[3] Novo Nordisk R&D Pipeline. From https://www.novonordisk.com/science-and-technology/r-d-pipeline.html
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