Novo Nordisk's Oral Dual Agonist Amycretin Granted Clinical Trial Approval in China with 13.1% Weight Loss in 12 Weeks

Jun 27, 2024 07:58 CST Updated 07:58

Novo Nordisk

Insulin Developer and Manufacturer

▎WuXi AppTec Content Team Report

June 26,The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,Novo Nordisk (Novo NNovo Nordisk) Class 1 New Drug AMycretin tablets have been approved for clinical use and are intended forReduce the weight of overweight or obese adult patients. Public information shows,This is a product developed by Novo Nordisk.Long-acting Dual Agonist of Oral GLP-1 Receptor and Amylin Receptor, a new generation of weight loss therapy.

In a small Phase 1 clinical study previously published by Novo Nordisk,The weight loss of patients who received the product treatment for 12 weeks reached 13.1% (vs 1.1% in the placebo group)., demonstrating rapid weight loss effects and good clinical application potential.

Screenshot source: CDE official website

Amylin is another hormone related to hunger and satiety, apart from the GLP-1 signaling pathway.Studies have shown that amylin can reduce energy intake, regulate food choices and preferences, exert glucose regulation through co-secretion with insulin, inhibit postprandial glucagon release, and delay gastric emptying.In addition,Amylin receptors are also expected to synergize with GLP-1 receptor agonists.

According to the official website of Novo Nordisk, amycretin is aLong-acting co-agonist of GLP-1R and amylin receptor, Two formulations are under development: subcutaneous injection (once a week) and oral (once a day). The currently proposed indication for development is obesity.

In March this year, Novo Nordisk announced the oral amycretin.The latest clinical trial results.This is aA small Phase 1 trial involving 16 patients showed that patients experienced a 13.1% reduction in body weight after 12 weeks of treatment, compared to only a 1.1% decrease in body weight for the placebo group.In addition, amycretin demonstrated favorable pharmacokinetic properties, as well as a safety, tolerability, and adverse event profile similar to those of the GLP-1 class therapies under development.

▲Oral amycretin shows significant weight loss effect in Phase 1 trial(Image source: Reference [2])

Industry media Fierce Biotech pointed out that the previous STEP-1 clinical trial results showed that the weight loss of patients in the semaglutide group was 14.9% during the 68-week trial period.Although the results between different clinical trials are difficult to compare together,But the positive effects shown by amycretin in the early results of the Phase 1 trial suggest that the drug has great potential for weight loss.

Novo Nordisk has been conducting research in the field of obesity treatment for more than 25 years. In May this year,Annual Media Communication MeetingUp，Dr. Marcus Schindler, Executive Vice President of Research and Early Development at Novo Nordisk, also introduced the company.Five Directions in Obesity Treatment Research and Development, includingThrough the exploration of combined mechanisms of action (e.g., GLP-1/amylin) for better efficacy, as well as reduced dosing frequency, etc.

References:

[1]Center for Drug Evaluation, National Medical Products Administration of China (CDE) Official Website. Retrieved June 26, 2024, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
[2] Highlights to be presented at Novo Nordisk’s Capital Markets Day 2024. Retrieved March 7, 2024 from https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=167029

This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media, but unauthorized reproduction by media or institutions in any form on other platforms is strictly prohibited.For authorization to reproduce, please leave a message on the "Med Observer" WeChat Official Account. For other collaboration inquiries, please contact wuxi_media@wuxiapptec.com.

Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange purposes only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it indicate that WuXi AppTec supports or opposes these views. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.