Saxenda® Demonstrated Improvements in BMI and Body Weight in Adolescents With Obesity

Bagsværd, Denmark (ots/PRNewswire) - Novo Nordisk today announced that the New
England Journal of Medicine published results of a phase 3 trial evaluating the
investigational use of Saxenda® (liraglutide 3.0 mg) in adolescents (aged
12-<18) with obesity.1 The study was accepted for presentation at ENDO 2020, the
Endocrine Society's annual meeting in San Francisco, US, and will be published
in a supplemental issue of the Journal of the Endocrine Society .2 Saxenda® is
currently indicated for chronic weight management in adults with a BMI >=30
kg/m2, or >=27 kg/m2 with one or more weight-related comorbidities, as an
adjunct to a reduced-calorie diet and increased physical activity.3,4

The trial was designed to evaluate the efficacy and safety of Saxenda® in this
population and achieved its primary endpoint demonstrating that Saxenda®,
compared with placebo, was superior in reducing Body Mass Index (BMI) standard
deviation score (SDS) at 56 weeks with a -0.22 estimated treatment difference
(ETD).1,2 BMI-SDS is a measure of relative weight status adjusted for age and
gender in children and adolescents.2,5 The study was a post-marketing
requirement of the FDA6 and the EMA in agreement with Paediatric Investigation
Plan (PIP),7,8 both of which aim to ensure treatments are safe and effective for
children and adolescents.

Over the last 20 years, the global prevalence of overweight and obesity in
children and adolescents has doubled from 1 in 10 to 1 in 5.9 However, current
treatment options for this population are limited, highlighting a considerable
and growing need for additional strategies.10

"Most adolescents with obesity are likely to have obesity as adults and are at
increased risk for developing other weight-related diseases, which is why it's
so important to address weight care and support early on," said Dr Aaron Kelly,
Professor of Pediatrics and Co-Director of the Center for Pediatric Obesity
Medicine at the University of Minnesota. "Today, treatment options beyond
behavioural counselling are limited for adolescents with obesity. Anti-obesity
medications could provide a key option as part of a personalised, complete care
plan to help them lose weight and keep it off."

In the trial, following 56 weeks of treatment, there was a difference in change
in BMI (kg/m2) with adolescents in the Saxenda® arm achieving a 4.29% reduction
in BMI, compared to a 0.35% increase with placebo. In addition, 43.3% of
adolescents treated with Saxenda® had a 5%, or more, reduction in BMI at week 56
(compared to 18.7% on placebo) and 26.1% had a 10%, or more, reduction (compared
to 8.1% with placebo).1,2

"We are encouraged by these results and the progress made to provide a treatment
option for healthcare professionals caring for adolescents living with obesity,"
said Mads Krogsgaard Thomsen, executive vice president and chief science officer
of Novo Nordisk. "It's vital that families affected by obesity have the tools
and resources needed to address this health issue. These data add to the
extensive evidence for the clinical use and value of Saxenda® and support Novo
Nordisk's commitment to improving the lives of people with obesity."

There were no new safety signals identified, and no severe hypoglycaemias were
reported, and adverse events were similar to those observed in adults. During
the 56-week treatment period, 64.8% of adolescents on Saxenda® reported
gastrointestinal adverse events, compared to 36.5% of those receiving placebo.
Three adolescents on Saxenda® reported serious adverse events, versus five in
the placebo group. A greater number of adolescents discontinued treatment due to
adverse events with Saxenda® (10.4%) compared to placebo (0%), primarily related
to gastrointestinal side effects.1,2

About the phase 3 trial (NCT02918279)

The trial was a phase 3a randomised, double-blind, placebo-controlled clinical
trial investigating the effect of Saxenda® (liraglutide) injection 3.0 mg
compared to placebo for weight management in 251 adolescents living with obesity
as an adjunct to lifestyle therapy, defined as counselling in healthy nutrition
and physical activity for weight loss. The trial included a 12-week run-in of
lifestyle therapy, a 56-week treatment period (including dose escalation of 4 to
8 weeks) on Saxenda® or placebo and a 26-week follow-up period without Saxenda®
or placebo. All participants received lifestyle therapy beginning with the
run-in period and during the 56-week treatment period and 26-week follow-up
period.1,2

In the trial, the primary endpoint was change from baseline inBMI-SDS at week
56. BMI is a calculation of weight (kg) divided by the square of height in
metres. BMI-SDS is a measure of relative BMI status that accounts for age and
gender.2,5

About Saxenda®

Saxenda® (liraglutide 3.0 mg) is a once-daily glucagon-like peptide-1 (GLP-1)
analogue with 97% similarity to naturally occurring human GLP-1,4,11 a hormone
that is released in response to food intake.12 Like human GLP-1, Saxenda®
regulates appetite by increasing feelings of fullness and satiety, while
lowering feelings of hunger, thereby leading to reduced food intake.4,11,13 As
with other GLP-1 analogues, Saxenda® stimulates insulin secretion and lowers
glucagon secretion in a glucose-dependent manner.4,13 Saxenda® for use in adults
with obesity was evaluated in the SCALE (Satiety and Clinical Adiposity -
Liraglutide Evidence) clinical trial programme. Since launch in 2015, more than
1.5 million patients have been treated with Saxenda ® globally.6

Saxenda® is currently indicated for chronic weight management in adults with a
BMI >=30 kg/m2, or >=27 kg/m2 with one or more weight-related comorbidities, as
an adjunct to a reduced-calorie diet and increased physical activity.3,4

About adolescent obesity

Obesity is a chronic disease that is influenced by multiple aspects, including
physiological, psychological, genetic, environmental and socioeconomic
factors.14 80% of adolescents who live with obesity are likely to have obesity
as an adult.15 Adolescents with obesity are also more likely to develop
weight-related diseases, like diabetes and cardiovascular diseases, at a younger
age.16Just like other chronic diseases, obesity requires long-term
management.17-20 The global increase in the prevalence of obesity is a public
health issue that has severe cost implications to healthcare systems.21,22
Globally over 100 million children and adolescents have obesity.23

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 42,700 people in 80 countries and markets its products in around
170 countries. For more information, visit http://www.novonordisk.com/ ,
Facebook (http://www.facebook.com/novonordisk) , Twitter
(http://www.twitter.com/novonordisk) , LinkedIn
(http://www.linkedin.com/company/novo-nordisk) , YouTube
(http://www.youtube.com/novonordisk) .

References
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Voting at Annual Meeting. Obesity as a Disease. Available at: http://news.ci
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Statement Focuses on Obesity as a Chronic Disease. Available at: https://www
.prnewswire.com/news-releases/the-obesity-society-updates-position-on-obesit
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Contact:

Mette Kruse Danielsen
[phone]
[e-mail]. Ken Inchausti (US)
[phone]
[e-mail]. Liz Skrbkova (US)
+ 1 609 917 0632
[e-mail]. Investors: Daniel Muusmann Bohsen
[phone]
[e-mail]. Valdemar Borum Svarrer
[phone]
[e-mail]. Ann Søndermølle Rendbæk
[phone]
[e-mail]
Mark Joseph Root
[phone]
[e-mail]. Kristoffer Due Berg (US)
[phone]
[e-mail]

Additional content: https://www.presseportal.de/pm/57206/4561461
OTS: Novo Nordisk A/S