Lose weight by 13.1% in 12 weeks! Novo Nordisk's new generation oral weight loss therapy data released

Novo Nordisk announced the Phase I study data of the oral weight-loss drug Amycretin (NN9487) at the EASD annual meeting, showing an average weight reduction of 13.1% in the 100mg dose group. The drug is a GLP-1R/AMYR agonist, with an oral dosage form taken once daily. The study results indicate significant weight loss effects in the 50mg and 100mg dose groups, which were 10.4% and 13.1% respectively, while the placebo group was only 1.1%. Novo Nordisk plans to decide whether to proceed directly to Phase III study after obtaining the Phase I study data of NN9490 next year

On September 11th, Novo Nordisk announced the first-phase study data of oral Amycretin (NN9487) at the European Association for the Study of Diabetes (EASD) annual meeting.

Amycretin is a glucagon-like peptide-1 receptor/amylin receptor (GLP-1R/AMYR) agonist developed by Novo Nordisk. The subcutaneous injection formulation (NN9490) is administered once a week, while the oral formulation is administered once daily.

The Phase I study results announced this time include 3 parts:

Part A (single dose escalation study): Subjects received doses of 1/3/6/12/25mg of NN9487 or placebo treatment;
Part B (multiple dose escalation study): Subjects received doses of 3/6/12mg of NN9487 or placebo treatment for 10 days;
Part C: Subjects received 12 weeks of titrated doses of NN9487 or placebo treatment, with doses of 3/6mg in weeks 1-2, 6/12mg in weeks 3-4, 12/25mg in weeks 5-6, 25/50mg in weeks 7-8, 25/50mg in weeks 9-10, and 50mg or 100mg in weeks 11-12.

Subjects had a baseline BMI of 25.0-39.9kg/m2. The results showed that subjects in the 50mg and 100mg dose groups had an average weight reduction of 10.4% and 13.1% respectively, while the placebo group had a reduction of 1.1%.

Martin Holst Lange, development director at Novo Nordisk, stated that the positive results support further validation of NN9487's weight loss effects. A decision will be made after obtaining Phase I study data of NN9490 next year. If the data is excellent, skipping Phase II studies and directly conducting pivotal Phase III studies is possible.

Based on current data, NN9487 shows very promising weight loss effects. Currently, the fastest progressing oral small molecule GLP-1 drug, Orforglipron (Li Auto), achieved a weight loss of 14.7% in 36 weeks (dose of 45mg, placebo group reduction of 2.3%).

PharmaCube, original title: "Weight Loss of 13.1% in 12 Weeks! Novo Nordisk's New Generation Oral Weight Loss Therapy Data Revealed"