Early Response to Saxenda(R) Resulted in Weight Maintenance and Additional Weight Loss Over 56 Weeks

PR68598

PORTO, Portugal, May 18, 2017 /PRNewswire=KYODO JBN/ --

    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(R) (liraglutide 3 mg)

or placebo. After 16 weeks of treatment with Saxenda(R), 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(R) 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(R) are able to both maintain and achieve

additional weight loss".

    Of those who completed 56 weeks of treatment with Saxenda(R), 68% were

early responders to Saxenda(R) 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 (R), 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(R) 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(R)

    Saxenda(R) (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(R) 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(R) stimulates insulin secretion and lowers glucagon secretion in a

glucose-dependent manner.[2] Saxenda(R) was evaluated in the SCALE (Satiety and

Clinical Adiposity - Liraglutide Evidence) phase 3a clinical trial programme.

    In the EU, Saxenda(R) 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 greater than or equal to30 kg/m2 (obese), or greater than or

equal to27 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(R) 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 greater

than or equal to30 kg/m2) or who were overweight (BMI greater than or equal

to27 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(R) (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(R) (liraglutide 3 mg) summary of product characteristics.

Available at:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003780/WC500185786.pdf

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

     Asa 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 Ogren     

     +45-3079-8519     

     haoe@novonordisk.com

     Kasper Veje (US)     

     +1-609-235-8567     

     kpvj@novonordisk.com

Source: Novo Nordisk