Bagsværd, Denmark, 12 June 2025 - Novo Nordisk today announced that it will advance subcutaneous and oral amycretin into phase 3 development in weight management based on completed clinical studies. The decision to advance subcutaneous and oral amycretin into phase 3 is based on feedback received from regulatory authorities following end-of-phase 2 interactions for subcutaneous and oral amycretin in weight management.
"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," said Martin Lange, executive vice president for Development at Novo Nordisk. "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."
Novo Nordisk is now planning to initiate a phase 3 development programme with amycretin for adults with overweight or obesity during the first quarter of 2026.
About amycretin
Amycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide an efficacious and convenient treatment for adults with overweight or obesity and for adults with type 2 diabetes. Amycretin is developed for subcutaneous and oral administration.
Oral Amycretin Phase 1 trial - The trial evaluated the single-ascending dose and multiple-ascending doses for oral amycretin, up to 2 times 50 mg, in people with overweight or obesity, with a total treatment duration of up to 12 weeks.
Subcutaneous Amycretin Phase 1b/2a trial - The trial investigated the safety, tolerability, pharmacokinetics, and proof-of-concept of once-weekly subcutaneous amycretin in people with overweight or obesity. The trial was a combined single ascending dose, multiple ascending dose and dose-response trial investigating three different maintenance doses with a total treatment duration of up to 36 weeks.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen,Facebook, Instagram, X, LinkedIn andYouTube.
Contacts for further information
| Media: | |
| Ambre James-Brown +45 3079 9289 abmo@novonordisk.com (mailto:abmo@novonordisk.com) | Liz Skrbkova (US) +1 609 917 0632 lzsk@novonordisk.com (mailto:lzsk@novonordisk.com) |
| Investors: | |
| Jacob Martin Wiborg Rode +45 3075 5956 jrde@novonordisk.com (mailto:jrde@novonordisk.com) | Sina Meyer +45 3079 6656 azey@novonordisk.com (mailto:azey@novonordisk.com) |
| Max Ung +45 3077 6414 mxun@novonordisk.com (mailto:Mxun@novonordisk.com) | Frederik Taylor Pitter +1 609 613 0568 fptr@novonordisk.com (mailto:fptr@novonordisk.com) |
Company announcement No 17 / 2025
Attachment
- CA250612-amycretin-to-phase-3-clean (https://ml-eu.globenewswire.com/Resource/Download/0cc57835-7bb3-4f4c-88a4-ff473d752d78)
