Novo Nordisk Unveils Promising Phase I Data for Oral Amycretin (NN9487) in Obesity Treatment

Sep 12, 2024 09:14 CST Updated 09:14

Novo Nordisk

Insulin Developer and Manufacturer

｜Edited by the Peptide Biotech Content Team

September 11, 2024Recently, Novo Nordisk presented 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. Its subcutaneous injection formulation (NN9490) is administered once weekly, and its oral formulation is administered once daily.

The phase I study, the results of which were announced this time, consists of three parts:

Part A (Single Ascending Dose 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 titrated dosing of NN9487 or placebo, with doses as follows: 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 or 100mg.

Baseline BMI of subjects was 25.0-39.9 kg/m². The results showed that the body weight of subjects in the 50mg and 100mg dose groups decreased by an average of 10.4% and 13.1%, respectively, compared to 1.1% in the placebo group.

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 very promising weight loss effects. The fastest-progressing oral small-molecule GLP-1 drug, Orforglipron (Eli Lilly), achieved a weight reduction of 14.7% within 36 weeks (at a dose of 45mg, compared to a 2.3% reduction in the placebo group).

AboutNovo Nordisk

Novo Nordisk, founded in 1923, is a global leading biopharmaceutical company headquartered in Copenhagen, the capital of Denmark. Our goal is to drive change to defeat diabetes and other serious chronic diseases such as obesity, rare blood disorders, and endocrine disorders. To achieve this goal, we lead scientific breakthroughs, expand the accessibility of our medicines, and are committed to preventing and ultimately curing these diseases. Novo Nordisk has approximately 47,000 employees across 80 countries and regions worldwide, providing products and services to more than 168 countries and regions globally.

Source:

1.PharmCube

2.Novo Nordisk