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

PR64658

GOTHENBURG, Sweden, June 3, 2016 / PRNewswire=KYODO JBN / --

    This material is intended for global medical media only.

    For journalistic assessment and preparation before publication.

    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(R) (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(R) 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(R) were early responders

versus 22.3% of people treated with placebo. At week 160, Saxenda(R) 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(R) 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(R) 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(R) 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(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, a

hormone that is released in response to food intake.[10] 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(TM) (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 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 greater than or equal to27 kg/m2) with comorbidities such as

hypertension, dyslipidaemia, obstructive sleep apnoea (OSA) or type 2 diabetes

or who have obesity (BMI greater than or equal to30 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, Skjoth 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(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: 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.

SOURCE: Novo Nordisk