Novo Nordisk has announced plans to advance subcutaneous and oral amycretin into phase 3 clinical development for weight management. This decision follows feedback from regulatory authorities after end-of-phase 2 interactions.
Martin Lange, executive vice president for Development at Novo Nordisk, stated, “We are very pleased that the feedback from regulatory authorities has allowed us to take subcutaneous and oral amycretin in weight management to phase 3. We are excited about the amycretin molecule, and this marks an important step forward. We look forward to sharing more information on the design of the phase 3 programme.”
The company intends to start a phase 3 development program with amycretin for adults with overweight or obesity in the first quarter of 2026.
Amycretin is being developed as a long-acting GLP-1 and amylin receptor agonist for treating adults with overweight or obesity and type 2 diabetes. It is designed for both subcutaneous and oral administration.
The oral Amycretin Phase 1 trial assessed single-ascending dose and multiple-ascending doses up to two times 50 mg over a treatment period of up to 12 weeks in individuals with overweight or obesity.
The subcutaneous Amycretin Phase 1b/2a trial examined safety, tolerability, pharmacokinetics, and proof-of-concept of once-weekly administration in individuals with overweight or obesity. This trial included single ascending dose, multiple ascending dose, and dose-response investigations over a total treatment duration of up to 36 weeks.
Novo Nordisk is a global healthcare company established in Denmark in 1923. The company focuses on addressing serious chronic diseases through scientific innovation. Novo Nordisk employs approximately 77,400 people across 80 countries and markets its products in around 170 countries.
