On September 11, Novo Nordisk announced the first Phase I weight loss study data of oral Amycretin (NN9487) at the annual meeting of the European Association for the Study of Diabetes (EASD).Amycretin is a glucagon-like peptide-1 receptor/amylin receptor (GLP-1R/AMYR) agonist developed by Novo Nordisk.Subcutaneous Injection Formulation (NN9490)The medication frequency isOnce a week, itsOral dosage formThe medication frequency isOnce daily。The phase I study, the results of which were announced this time, consists of three parts:- Part A (Single Dose Escalation Study): Subjects received NN9487 or placebo at doses of 1/3/6/12/25mg.
- Part B (Multiple Ascending Dose Study): Subjects received NN9487 or placebo at doses of 3/6/12mg for 10 days.
- Part C: Subjects receive 12 weeks of titration dosing with NN9487 or placebo, with weeks 1-2 at 3/6mg, weeks 3-4 at 6/12mg, weeks 5-6 at 12/25mg, weeks 7-8 at 25/50mg, weeks 9-10 at 25/50mg, and weeks 11-12 at 50mg.100mg。
Subjects with baseline BMI of 25.0-39.9 kg/m²2. The results showed,50mgAnd100mgThe body weight of subjects in the dose group decreased by an average of10.4%And13.1%, the proportion in the placebo group was 1.1%.
Novo Nordisk's Head of Development, Martin Holst Lange, stated that the positive results support further validation of NN9487's weight-loss effects, but a decision can wait until next year when Phase I study data for NN9490 becomes available; if the data is excellent, Phase II studies may be skipped to directly proceed to pivotal Phase III studies.Based on the current data, NN9487 has shown excellent weight loss effects. It is currently the fastest progressing oral small molecule GLP-1 drug.Orforglipron (Eli Lilly) achieved a weight loss of14.7%(Dosage:45mg, the placebo group decreased by 2.3%).
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