Early Response to Saxenda® Resulted in Weight Maintenance and Additional Weight Loss Over 56 Weeks

Porto, Portugal (ots/PRNewswire) -

Abstract# RS3:3

Today, results from a post hoc analysis of data from the SCALE
Maintenance trial were presented at the 24th European Congress on
Obesity (ECO) 2017. In the trial, adults who lost at least 5% of
their initial weight during a low- calorie run-in period were
randomised to receive Saxenda® (liraglutide 3 mg) or placebo. After
16 weeks of treatment with Saxenda®, participants who lost an
additional 5% or more of their body weight (defined as 'early
responders') were more likely to maintain weight loss and achieve
greater additional weight loss over 56 weeks, compared with people
losing less than 5% body weight after 16 weeks of Saxenda® treatment
('early non-responders').[1]

"In the obesity specialist setting, low-calorie diets combined
with increased physical activity are commonly used to induce an
initial weight loss in people with obesity. However, when the initial
weight loss reaches a plateau and patients enter the 'weight
maintenance phase' with less stringent caloric restriction, we often
see that many experience weight regain," said Dr Sean Wharton,
medical director at the Wharton Medical Clinic, Ontario and SCALE
clinical trial investigator. "As a consequence, pharmacotherapy can
be used to help people with obesity in maintaining the weight loss
that has already been achieved by a low-calorie diet and increased
physical activity. These data are very encouraging to clinicians in
this specialist setting, because they show that early responders to
Saxenda® are able to both maintain and achieve additional weight
loss."

Of those who completed 56 weeks of treatment with Saxenda®, 68%
were early responders to Saxenda® at week 16 and 32% were early
non-responders. In addition to weight loss achieved during the run-in
period, early responders experienced 9.9% weight loss, compared with
0.0% in early non-responders at 56 weeks.[1]

Following 56 weeks of treatment, 91.7% of early responders and
47.1% of early non-responders, had maintained or lost additional
weight following the run-in period. No early responders regained
their run-in weight loss over 56 weeks of treatment with Saxenda®,
compared with 3.9% of early non-responders.[1]

There were similar incidences of total adverse events in early
responders (92.7%) and early non-responders (91.0%). Gastrointestinal
adverse events were more frequent in early responders compared with
early non-responders (78.9% vs 62.7%).[1] Saxenda® was generally
well-tolerated, with observed side effects in line with previous
trials.[2]

About obesity

Obesity is a disease[3],[4]that requires long-term management. It
is associated with many serious health consequences and decreased
life expectancy.[5],[6] Obesity-related comorbidities include type 2
diabetes, heart disease, obstructive sleep apnoea (OSA) and certain
types of cancer.[5],[7],[8]It is a complex and multi-factorial
disease that is influenced by physiological, psychological,
environmental, socio-economic and genetic factors.[9]

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.[10]

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,[2] a hormone that is released in response to food
intake.[11] 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
(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 after 12 weeks on the liraglutide 3.0 mg/day dose, if
patients have not lost at least 5% of their initial body weight.[2]

About the SCALE Maintenance clinical trial

In the SCALE Maintenance clinical trial, adults with obesity (BMI
>=30 kg/m2) or who were overweight (BMI >=27 kg/m2 to <30 kg/m2) with
comorbidities (dyslipidaemia and/or hypertension), who lost at least
5% of their initial weight during a low-calorie diet (1200-1400
kcal/day) run-in period, were randomised to receive Saxenda® (n=212)
or placebo (n=210) for 56 weeks, both as an adjunct to a
reduced-calorie diet and increased physical activity.[1]

Novo Nordisk's phase 3 development programme, called SCALE,
investigated liraglutide 3 mg for weight management. The SCALE
clinical development programme consisted of four, placebo-controlled,
multinational trials called: SCALE Obesity and Prediabetes, SCALE
Diabetes, SCALE Sleep Apnoea and SCALE Maintenance.[12-16]

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 42,000 people in 77 countries and markets its products
in more than 165 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)

References

1. Wharton S, Jacobsen P, Arrone L. Early responders to
liraglutide 3.0 mg as adjunct to diet and exercise from the SCALE
Maintenance trial. Oral presentation number RS3:3. ECO. 2017.

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: May 2017.

3. American Medical Association. A.M.A Adopts New Policies on
Second Day of Voting at Annual Meeting. Obesity as a Disease.
Available at: http://www.ama-assn.org/ama/pub/news/news/2013/2013-06-
18-new-ama-policies-annual-meeting.page Last accessed: May 2017.

4. WHO. Obesity: Preventing and managing the global epidemic.
Available at: http://www.who.int/iris/handle/10665/42330 Last
accessed: May 2017.

5. 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.

6. 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.

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

8. 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.

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

10. WHO. Obesity and Overweight Factsheet no. 311. Available at:
http://www.who.int/mediacentre/factsheets/fs311/en/ Last accessed:
May 2017.

11. 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.

12. 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; 40:1310-1319.

13. 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.

14. Pi-Sunyer X, Astrup A, Fujioka K, et al. A Randomized,
Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N
Engl J Med. 2015; 373:11-22.

15. le Roux C, Astrup A, Fujioka K, et al. 3 years of liraglutide
versus placebo for type 2 diabetes risk reduction and weight
management in individuals with prediabetes: a randomised,
double-blind trial. The Lancet. 2017; (published online Feb 22.)
http://dx.doi.org/10.1016/S0140-6736(17)30069-7.

16. 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.

Further information

Media:

Katrine Sperling

+45-4442-6718

krsp@novonordisk.com

Åsa Josefsson

+45-3079-7708

aajf@novonordisk.com

Investors:

Peter Hugreffe Ankersen

+45-3075-9085

phak@novonordisk.com

Anders Mikkelsen

+45-3079-4461

armk@novonordisk.com

Hanna Ögren

+45-3079-8519

haoe@novonordisk.com

Kasper Veje (US)

+1-609-235-8567

kpvj@novonordisk.com

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