PR83519

BAGSVÆRD, Denmark, April 1, 2020 /PRNewswire=KYODO JBN/ --

Novo Nordisk today announced that the New England Journal of Medicine published

results of a phase 3 trial evaluating the investigational use of Saxenda(R)

(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(R) is currently indicated for

chronic weight management in adults with a BMI greater than or equal to 30

kg/m2, or greater than or equal to 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(R) in

this population and achieved its primary endpoint demonstrating that

Saxenda(R), 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(R) 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(R) 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(R) 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(R) reported

gastrointestinal adverse events, compared to 36.5% of those receiving placebo.

Three adolescents on Saxenda(R) reported serious adverse events, versus five in

the placebo group. A greater number of adolescents discontinued treatment due

to adverse events with Saxenda(R) (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(R) (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(R) or placebo and a 26-week follow-up

period without Saxenda(R) 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 in BMI-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(R)

Saxenda(R) (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(R)

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(R) stimulates

insulin secretion and lowers glucagon secretion in a glucose-dependent

manner.[4],[13] Saxenda(R) 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(R) globally.[6]

Saxenda(R) is currently indicated for chronic weight management in adults with

a BMI greater than or equal to 30 kg/m2, or greater than or equal to 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.[16] Just 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 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

1. Kelly A, Auerbach P, Barrientos-Perez M, et al. A randomized, controlled

trial of liraglutide for adolescents with obesity. New England Journal of

Medicine. 2020.

2. Kelly A, Auerbach P, Barrientos-Perez M. Liraglutide for weight management

in pubertal adolescents with obesity: a randomized controlled trial. Journal of

the Endocrine Society. Volume 4, Issue supplement 1. April–May 2020.

3. FDA. Saxenda(R) (liraglutide 3 mg) US Prescribing Information. Available at:

http://www.novo-pi.com/saxenda.pdf. Last accessed: March 2020.

4. EMA. Saxenda(R) (liraglutide 3 mg) summary of product characteristics.

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Last accessed: March 2020.

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6. Novo Nordisk. Data on file.

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at: https://easo.org/2015-milan-declaration-a-call-to-action-on-obesity/. Last

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18. American Medical Association. A.M.A Adopts New Policies on Second Day of

Voting at Annual Meeting. Obesity as a Disease. Available at:

http://news.cision.com/american-medical-association/r/ama-adopts-new-policies-on-second-day-of-voting-at-annual-meeting,c9430649.

Last accessed: March 2020.

19. Bray GA, Kim KK, Wilding JPH, et al. Obesity: a chronic relapsing

progressive disease process. A position statement of the World Obesity

Federation. Obes Rev. 2017; 18:715–723.

20. The Obesity Society. The Obesity Society Updates Position on Obesity. New

Statement Focuses on Obesity as a Chronic Disease. Available at:

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21. World Health Organization. Obesity and Overweight Factsheet no. 311.

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22. Cawley J, Meyerhoefer C, Biener A, et al. Savings in Medical Expenditures

Associated with Reductions in Body Mass Index Among US Adults with Obesity, by

Diabetes Status. Pharmacoeconomics. 2015; 33:707–722.

23. The GBD 2015 Obesity Collaborators. Health Effects of Overweight and

Obesity in 195 Countries over 25 Years. New England Journal of Medicine. 2017;

377:13–27.

Source: Novo Nordisk