Novo Nordisk to advance subcutaneous and oral amycretin for weight management into phase 3 clinical development
12 Juni 2025 - 7:06PM
UK Regulatory
Novo Nordisk to advance subcutaneous and oral amycretin for weight
management into phase 3 clinical development
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 (Novo-B).
Its ADRs are listed on the New York Stock Exchange (NVO). For more
information, visit novonordisk.com,
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YouTube.
Contacts for further information
Media: |
|
Ambre
James-Brown
+45 3079 9289
abmo@novonordisk.com
|
Liz
Skrbkova (US)
+1 609 917 0632
lzsk@novonordisk.com
|
Investors: |
|
Jacob
Martin Wiborg Rode
+45 3075 5956
jrde@novonordisk.com
|
Sina
Meyer
+45 3079 6656
azey@novonordisk.com
|
Max
Ung
+45 3077 6414
mxun@novonordisk.com
|
Frederik
Taylor Pitter
+1 609 613 0568
fptr@novonordisk.com
|
Company announcement No 17 / 2025
- CA250612-amycretin-to-phase-3-clean
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