Three-year Data Show Early Response to Saxenda® Resulted in Improvements in Weight Loss and Cardiometabolic Risk Factors

Gothenburg, Sweden (ots/PRNewswire) -

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Poster# PP3.09

Today, data from a post hoc analysis of the three-year part of the
phase 3a SCALE(TM) (Satiety and Clinical Adiposity - Liraglutide
Evidence) Obesity and Prediabetes trial were presented at the first
European Obesity Summit (EOS 2016). Adults with prediabetes and
obesity or who were overweight with comorbidities were randomised to
receive Saxenda® (n=1,505) or placebo (n=749) for 160 weeks, both as
an adjunct to a reduced-calorie diet and increased physical activity.
People treated with Saxenda® who lost 5% or more of their body weight
at 16 weeks (classified as 'early responders') demonstrated greater
weight loss and improvements in cardiometabolic risk factors at week
160 compared with those who lost less than 5% of their body weight at
16 weeks ('early non-responders').[1]

At week 16, 68.0% of people treated with Saxenda® were early
responders versus 22.3% of people treated with placebo. At week 160,
Saxenda® early responders who completed the trial (n=580) achieved an
average weight loss of 8.6% (9.1 kg), compared with 2.9% (3.1 kg) in
early non-responders (n=210). In addition, Saxenda® early responders
experienced improvements across a range of glycaemic measures
including regression to normoglycaemia (69.8 vs 55.4%) and reduced
development of type 2 diabetes (0.5 vs 3.2%) compared with early
non-responders.[1]

"These findings demonstrate the predictive nature of an early
response to treatment, which is important information that clinicians
can use to identify those who are most likely to experience long-term
benefits with Saxenda," said Professor Sten Madsbad, Clinical
Professor at the University of Copenhagen and SCALE(TM) clinical
trial investigator. "It is also encouraging that we continue to see
benefits in addition to weight loss experienced with Saxenda,
including improvements in cardiometabolic risk factors and glycaemic
status for people completing the trial."

For those completing 160 weeks of treatment, Saxenda® early
responders also experienced greater improvements in systolic blood
pressure (-3.7 vs -3.3 mmHg), and improvements in health-related
quality of life measures (IWQoL-Lite score 13.4 vs 9.5) compared with
early non-responders.[1]

Saxenda® was generally well-tolerated, and observed side effects
were in line with previous trials.[2] Rates of adverse events were
similar between early responders and early non-responders (97.1 vs
95.0%). The most common side effects reported by early responders and
early non-responders were related to the gastrointestinal system
(75.3 vs 71.6%). Gallbladder disorders were more frequent in early
responders compared with early non-responders (6.3 vs 2.2%).[1]

About obesity

Obesity is a disease[3] that requires long-term management. It is
associated with many serious health consequences and decreased
life-expectancy.[4],[5] Obesity-related comorbidities include type 2
diabetes, heart disease, obstructive sleep apnoea (OSA) and certain
types of cancer.[4],[6],[7] It is a complex and multi-factorial
disease that is influenced by genetic, physiological, environmental
and psychological factors.[8]

The global increase in the prevalence of obesity is a public
health issue that has severe cost implications to healthcare systems.
In 2014, 13% of adults, or approximately 600 million adults, were
living with obesity.[9]

About Saxenda®

Saxenda® (liraglutide 3 mg) is a once-daily glucagon-like
peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring
human GLP-1, a hormone that is released in response to food
intake.[10] Like human GLP-1, Saxenda® regulates appetite by
increasing feelings of fullness and satiety, while lowering feelings
of hunger and prospective food consumption, thereby leading to
reduced food intake. As with other GLP-1 receptor agonists, Saxenda®
stimulates insulin secretion and lowers glucagon secretion in a
glucose-dependent manner.[2] Saxenda® was evaluated in the SCALE(TM)
(Satiety and Clinical Adiposity - Liraglutide Evidence) phase 3a
clinical trial programme.

In the EU, Saxenda® is indicated as an adjunct to a
reduced-calorie diet and increased physical activity for weight
management in adult patients with an initial BMI of >=30 kg/m2
(obese), or >=27 kg/m2 to <30 kg/m2 (overweight) in the presence of
at least one weight-related comorbidity such as dysglycaemia
(prediabetes or type 2 diabetes mellitus), hypertension,
dyslipidaemia or obstructive sleep apnoea.[2]

Guidance is given in the label that treatment with Saxenda® should
be discontinued if 5% weight loss has not been achieved by 16
weeks.[2]

About the SCALE(TM) clinical development programme

Novo Nordisk's phase 3 development programme, called SCALE(TM),
investigates liraglutide 3 mg for weight management. SCALE(TM)
(Satiety and Clinical Adiposity - Liraglutide Evidence) consists of
four, placebo-controlled, multinational trials called: SCALE(TM)
Obesity and Prediabetes, SCALE(TM) Diabetes, SCALE(TM) Sleep Apnoea
and SCALE(TM) Maintenance.[11]-[14] The trials include more than
5,000 people who are overweight (BMI >=27 kg/m2) with comorbidities
such as hypertension, dyslipidaemia, obstructive sleep apnoea (OSA)
or type 2 diabetes or who have obesity (BMI >=30 kg/m2), with or
without comorbidities. The studies all involved a reduced-calorie
diet and increased physical activity.

Key results from all trials in the SCALE(TM) clinical development
programme have been published, with further data expected to be
presented and published throughout 2016.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90
years of innovation and leadership in diabetes care. This heritage
has given us experience and capabilities that also enable us to help
people defeat other serious chronic conditions: haemophilia, growth
disorders and obesity. Headquartered in Denmark, Novo Nordisk employs
approximately 41,600 people in 75 countries and markets its products
in more than 180 countries. For more information, visit
novonordisk.com (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)

Further information
Media:

Katrine Sperling

+45-4442-6718

krsp@novonordisk.com

Ken Inchausti (US)

+1-609-786-8316

kiau@novonordisk.com

Investors:

Peter Hugreffe Ankersen

+45-3075-9085

phak@novonordisk.com

Melanie Raouzeos

+45-3075-3479

mrz@novonordisk.com

Kasper Veje (US)

+1-609-235-8567

kpvj@novonordisk.com

References

1. Madsbad S GF, Lau DCW, O'Neil P, Wilding JPH, Jacobsen PB,
Skjøth TV, Fujioka K. Early weight loss responders to liraglutide 3.0
mg achieved greater weight loss and regression to normoglycaemia, and
reduced development of T2D at 3 years, versus early non-responders in
the SCALE Obesity and Prediabetes trial. EOS 2016.

2. EMA. Saxenda® (liraglutide 3 mg) summary of product
characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/do
cument_library/EPAR_-_Product_Information/human/003780/WC500185786.pd
f . Last accessed: April 2016.

3. American Medical Association A. Declaration to classify
obesity as a disease. Annual Meeting Report. 19 June 2013.

4. Guh DP, Zhang W, Bansback N, et al. The incidence of
co-morbidities related to obesity and overweight: a systematic review
and meta-analysis. BMC Public Health 2009; 25:88.

5. Peeters A, Barendregt JJ, Willekens F, et al. Obesity in
adulthood and its consequences for life expectancy: a life-table
analysis. Annals of Internal Medicine 2003; 138:24-32.

6. Gami AS, Caples SM, Somers VK. Obesity and obstructive sleep
apnea. Endocrinology and Metabolism Clinics of North America 2003;
32:869-894.

7. Whitlock G, Lewington S, Sherliker P, et al. Body-mass index
and cause-specific mortality in 900 000 adults: collaborative
analyses of 57 prospective studies. Lancet 2009; 373:1083-1096.

8. Wright SM, Aronne LJ. Causes of obesity. Abdominal Imaging
2012; 37:730-732.

9. WHO. Obesity and Overweight Factsheet no. 311. Available at:
http://www.who.int/mediacentre/factsheets/fs311/en/ . Last accessed
February 2016.

10. Knudsen LB, Nielsen PF, Huusfeldt PO, et al. Potent
derivatives of glucagon-like peptide-1 with pharmacokinetic
properties suitable for once daily administration. Journal of
Medicinal Chemistry 2000; 43:1664-1669.

11. Blackman A, Foster G, Zammit G, et al. Effect of
liraglutide 3.0?mg in individuals with obesity and moderate or severe
obstructive sleep apnea: the SCALE Sleep Apnea randomized clinical
trial. International journal of obesity 2016; doi:
10.1038/ijo.2016.52. [Epub ahead of print].

12. Davies MJ, Bergenstal R, Bode B, et al. Efficacy of
liraglutide for weight loss among patients with type 2 diabetes: The
SCALE diabetes randomized clinical trial. Journal of the American
Medical Association 2015; 314:687-699.

13. Pi-Sunyer X, Astrup A, Fujioka K, et al. A randomized
controlled trial of 3.0 mg of liraglutide in weight management. New
England Journal of Medicine 2015; 373:11-22.

14. Wadden TA, Hollander P, Klein S, et al. Weight maintenance
and additional weight loss with liraglutide after
low-calorie-diet-induced weight loss: The SCALE Maintenance
randomized study. International Journal of Obesity 2013;
37:1443-1451.

ots Originaltext: Novo Nordisk A/S
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