Novo Nordisk to initiate phase 3a development in obesity with oral semaglutide
April 21 2021 - 9:52AM
Novo Nordisk to initiate phase 3a development in obesity with oral
semaglutide
Bagsværd,
Denmark,
21 April 2021 – Novo Nordisk
today announced the decision to enter phase 3a development in
obesity with oral semaglutide 50 mg. The decision follows the
completion of the STEP phase 3a clinical programme with once-weekly
subcutaneous (sc) semaglutide 2.4 mg.
Novo Nordisk intends to initiate a pivotal phase 3a programme
with approximately 1,000 people with obesity or overweight with
comorbidities. The global 68-week trial is planned for initiation
in the second half of 2021 and will investigate the efficacy and
safety of oral semaglutide compared to placebo.
“There is a significant unmet medical need within obesity
treatment today. With oral semaglutide we aim to introduce a
convenient and effective treatment option for people with obesity
and healthcare providers enabling broader use of anti-obesity
medication,” said Martin Holst Lange, executive vice president,
Development at Novo Nordisk. “As a complement to our injectable
anti-obesity medications, oral semaglutide has the potential to
help more people living with obesity achieve weight loss goals and
improve their health.”
About obesityObesity is a
chronic disease that requires long-term management. It is
associated with many serious health complications and decreased
life expectancy. Obesity-related complications are numerous and
include type 2 diabetes, cardiovascular disease, obstructive sleep
apnoea, non-alcoholic fatty liver disease and certain types of
cancer. The current COVID-19 pandemic has shown that obesity also
increases the risk of severe illness and hospitalisation due to
COVID-19.
The global increase in the prevalence of obesity is a public
health issue that has severe cost implications to healthcare
systems. Approximately 650 million adults are estimated to live
with obesity worldwide.
About semaglutide 2.4 mg for weight
management and STEPOnce-weekly sc
semaglutide 2.4 mg is currently under regulatory review in the US
and the EU as a treatment for adults with obesity. Semaglutide is
an analogue of the human glucagon-like peptide-1 (GLP-1) hormone.
It induces weight loss by reducing hunger, increasing feeling of
fullness and thereby helping people eat less and reduce their
calorie intake.
The submissions for regulatory review are based on the results
from the STEP (Semaglutide Treatment Effect in People with obesity)
phase 3 clinical development programme. The global clinical phase
3a programme consisted of four trials and enrolled approximately
4,500 adults with overweight or obesity.
About oral semaglutideOral
semaglutide (7 mg and 14 mg) is approved as an adjunct to diet and
exercise to improve glycaemic control in adults with type 2
diabetes in the US, EU and Japan under the trade name, Rybelsus®.
The approval of Rybelsus® is based on the results from 10 clinical
trials which included 9,543 adults with type 2 diabetes. Rybelsus®
demonstrated a safe and well-tolerated profile across the clinical
trials, with the most common adverse event being mild to moderate
nausea which diminished over time.
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
diabetes and other serious chronic diseases such as obesity and
rare blood and endocrine disorders. We do so by pioneering
scientific breakthroughs, expanding access to our medicines and
working to prevent and ultimately cure disease. Novo Nordisk
employs about 45,000 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, Facebook, Twitter, LinkedIn, YouTube.
Further information
Media: |
|
|
Mette Kruse
Danielsen |
+45 3079 3883 |
mkd@novonordisk.com |
Michael Bachner
(US) |
+1 609 664
7308 |
mzyb@novonordisk.com |
|
|
|
Investors: |
|
|
Daniel Muusmann
Bohsen |
+45 3075 2175 |
dabo@novonordisk.com |
Valdemar Borum
Svarrer |
+45 3079 0301 |
jvls@novonordisk.com |
Ann Søndermølle
Rendbæk |
+45 3075 2253 |
arnd@novonordisk.com |
Mark Joseph
Root |
+45 3079 4211 |
mjhr@novonordisk.com |
Kristoffer Due
Berg (US) |
+1 609 235
2989 |
krdb@novonordisk.com |
Company announcement No 25 / 2021
- PR210421_Oral_obesity_initiation
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