Novo Nordisk Initiates Phase I Clinical Trial of Next-Generation Weight Management Therapy NNC0487-0111 (Amycretin) in Chinese Population

On August 13 local time, the ClinicalTrials website showed that Novo Nordisk registered a trial to evaluateSingle-dose subcutaneous injectionNNC0487-0111 in Overweight or Obese Chinese PatientsPhase I Clinical Study on the Safety, Tolerability, and Pharmacokinetic Properties in Overweight Population(Registration No.:NCT07121153）。

Source:ClinicalTrials Official Website

This is a randomized, double-blind Phase I clinical trial, aimedInBody Mass Index (BMI) Between 24 kg/m² and 34.9kg/m² Evaluation of the Safety and Effects of NNC0487-0111 in Chinese Overweight or Obese Population Over 53 Days.

The study plans to enroll 36 subjects, who will be randomly assigned to receiveNNC0487-0111 or placebo treatment, with the specific dosing regimen as follows.

The primary endpoint of the study isAdverse events occurring during treatmentEvent（TEAE）Quantity, secondary endpoints include the area under the concentration-time curve from time 0 to infinity.（AUC0-∞）, Maximum Blood Drug Concentration（Cmax）etc.

NNC0487-0111（Amycretin）It is a novel single-molecule drug that can simultaneously activate long-acting glucagon-like peptide-1（GLP-1）And Amylin（AMY）Receptor, administered once a week.

In June this year, Novo Nordisk announced at the American Diabetes Association conferenceNNC0487-0111 Phase Ib/IIa Clinical Data for the Treatment of Overweight or Obese Patients.

The results showed,During the period of36 WeekB Part(Dose Escalation)In the trial, inject once a week60mg NNC0487-0111 PatientsThe average weight decreased.24.3%, while the placebo group lost an average of 1.1% of their weight,Weight loss effect after correcting for placebo effect23.2%Part C(Gradually increase from 0.3mg to the maintenance dose)of20 mg Dose Group Achieves Average Weight Loss of 22% at 36 Weeks。

Source: ADA Official Website, USA

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