Novo Nordisk's Amycretin Injection Receives Chinese IND Approval Following 22% Weight Loss in 36-Week Trial

Feb 26, 2025 17:26 CST Updated 17:26

Novo Nordisk

Insulin Developer and Manufacturer

▎Edited by the WuXi AppTec content team

Today (February 26),The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration has just announced,Novo Nordisk's Class 1 new drug Amycretin Injection has been approved for clinical trials and is proposed for development toReduce the weight of overweight or obese adult patients。Public information shows that amycretin is aA single-molecule glucagon-like peptide-1 (GLP-1) receptor and amylin receptor dual agonist administered once weekly via subcutaneous injection。Previously, the tablet form of this product has been approved for clinical use in China, intended to reduce body weight in overweight or obese adult patients.

This is the first time that the injectable solution has been approved for clinical use in China. The results of the Phase 1b/2a clinical trial recently published by Novo Nordisk show,Received the highest dose of amycretinInjectionParticipants in the TreatmentWeight decreased by 22.0% after 36 weeks。

Screenshot source: CDE official website

Amycretin is a product developed by Novo Nordisk.Single-molecule long-acting GLP-1 receptor and amylin receptor agonist, aiming to provide efficient and convenient treatment options for overweight or obese adults as well as adult patients with type 2 diabetes.AmylinIt 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.

AmycretinIs being developed asSubcutaneous injection (once a week)AndOral (Once Daily)Two dosage forms.Oral amycretin reported at the 2024 European Association for the Study of Diabetes (EASD) Annual MeetingClinical TrialData show that subjects receiving the highest dose of amycretin treatmentWeight decreased by 13.1% after 12 weeks. At that time, the industry media pointed out that the positive effects shown in the early results of this Phase 1 trial,This means that the drug has great potential in terms of weight loss.In June 2024, this oral formulation in ChinaApproved for Clinical Use。

The one approved for clinical use in China this time isAmycretin Subcutaneous Injection Formulation. In January 2025, Novo Nordisk announced this subcutaneous injection formulation.Results of Phase 1b/2a Clinical Trials for Treating Obese or Overweight Patients.The trial evaluated the safety, tolerability, pharmacokinetics, and clinical efficacy of once-weekly subcutaneous amycretin injections in 125 overweight or obese individuals. The study utilized three different maintenance doses, with a total treatment duration of up to 36 weeks.

The results showed that the average baseline weight of the patient group compliant with treatment was 92.7 kilograms.Patients receiving 1.25 mg dose of amycretin treatment experienced weight loss at 20 weeks.9.7%, the 5 mg dose group had a 16.2% weight loss at 28 weeks,The 20 mg dose group experienced a 22.0% weight loss at 36 weeks.In contrast, patients receiving placebo treatment experienced weight increases of 1.9%, 2.3%, and 2.0%, respectively.

Based on the research results, Novo Nordisk will further advanceAmycretin UseFor the treatment of adult patients who are overweight or obese. The approval of this product for clinical use in China marks another new development in its research progress.

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Feb 26, 2025, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2]Novo Nordisk successfully completes phase 1b/2a trial with subcutaneous amycretin in people with overweight or obesity. Retrieved Jan 24, 2024, from https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=915251

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