New Data on Saxenda(R) Show Early Response Predicts Improvements in Weight Loss and Cardiometabolic Risk Factors

PR61784

STOCKHOLM, Sweden, Sept. 15 /PRN=KYODO JBN/ --

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    Abstract #645

    Today, new data from a post-hoc analysis of the phase 3a SCALE(TM) clinical

development programme were presented at the 51st European Association for the

Study of Diabetes (EASD) Annual Meeting.[1] The data demonstrated that adults

in the SCALE(TM) Obesity and Prediabetes and SCALE(TM) Diabetes trials who lost

at least 5% of their body weight after completing 16 weeks of Saxenda(R)

(liraglutide 3 mg) treatment (defined as 'early responders') had greater weight

loss after completing 56 weeks, compared with people losing less than 5% body

weight with Saxenda(R) after completing 16 weeks ('early non-responders'). All

treatment groups included a reduced-calorie diet and increased physical

activity.[1]

    "These data demonstrate the importance of identifying those adults who

respond early to Saxenda(R)," said Professor Matthias Bluher, head of the

obesity outpatient clinic at the University of Leipzig, Germany, and SCALE(TM)

trial investigator. "Not only are these Saxenda(R) early responders more likely

to achieve greater weight loss over time, they are also more likely to

experience greater improvements in cardiometabolic risk factors."

    After completing 16 weeks of the SCALE(TM) Obesity and Prediabetes trial,

67.5% of adults with obesity or who were overweight with weight-related

comorbidities (excluding type 2 diabetes), were early responders to Saxenda(R)

(n=2487) and experienced an average weight loss of 11.5% after completing 56

weeks of treatment, compared with a weight loss of 3.8% for early

non-responders. The proportion of early responders losing greater than or equal

to5%, ＞10% and ＞15% of their bodyweight after completing 56 weeks was 88.2%,

54.8% and 24.2% respectively (36.9%, 8.3% and 1.8% respectively for early

non-responders).

    After completing 16 weeks of the SCALE(TM) Diabetes trial, 50.4% of adults

with obesity or who were overweight and had type 2 diabetes, were early

responders to Saxenda (R) (n=423), with a mean weight loss of 9.3% after

completing 56 weeks of treatment compared with a weight loss of 3.6% for early

non-responders. The proportion of early responders experiencing greater than or

equal to5%, ＞10% and ＞15% weight loss after completing 56 weeks was 80.1%,

44.6% and 11.6% respectively (33.3%, 5.8% and 1.3% respectively for early

non-responders).[1]

    Across both trials, early responders demonstrated greater improvements in

cardiometabolic risk factors, including blood pressure, cholesterol and

triglycerides, compared to early non-responders.[1]

    The overall safety profile was generally comparable between early

responders and early non-responders. In the SCALE(TM) Obesity and Prediabetes

trial serious adverse events occurred in 6.4% vs 5.3% respectively, and in the

SCALE(TM) Diabetes trial 7.6% vs 9.9%, respectively. Hepatobiliary events

(related to the liver and/or the gallbladder) were higher in early responders

compared with early non-responders in the SCALE(TM) Obesity and Prediabetes

trial (3.5% vs 2.1% respectively).[1] In people with obesity or who were

overweight and with type 2 diabetes, rates of severe hypoglycaemia were low in

both early responders and early non-responders (1.1% vs. 0.6% respectively) and

all cases were in people who were taking prescribed sulfonylureas.

    About obesity

    Obesity is a disease[2] that requires long-term management. It is

associated with many serious health consequences and decreased

life-expectancy.[3],[4] Obesity-related comorbidities include type 2 diabetes,

heart disease, obstructive sleep apnoea (OSA) and certain types of

cancer.[3],[5],[6] It is a complex and multi-factorial disease that is

influenced by genetic, physiological, environmental and psychological

factors.[7]

    The global increase in the prevalence of obesity is a public health issue

that has severe cost implications to healthcare systems. In the EU, obesity

affects approximately 10-30% of adults.[8]

    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.[9] 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.[10] These effects can lead to a reduction of fasting

and post-prandial blood glucose. Saxenda(R) was evaluated in the SCALE(TM)

(Satiety and Clinical Adiposity - Liraglutide Evidence in Nondiabetic and

Diabetic people) phase 3 clinical trial programme.

    Saxenda(R) was granted European marketing authorisation on 23 March 2015 by

the European Commission (EC). 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.[10]

    Saxenda(R) was approved by the FDA on 23 December 2014 and Health Canada on

26 February 2015. Please refer to local label for further information.

    Guidance is given in all labels that treatment with Saxenda(R) should be

discontinued if a specific threshold of weight loss has not been achieved after

a certain period of time.

    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 in Non-diabetic and Diabetic people)

consists of four, placebo-controlled, multinational trials called: SCALE(TM)

Obesity and Prediabetes, SCALE (TM) Diabetes, SCALE(TM) Sleep Apnoea and

SCALE(TM) Maintenance. 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

in 2015.

    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 39,700 people in

75 countries and markets its products in more than 180 countries. For more

information, visit novonordisk.com [http://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.   Bluher F, Hermansen K, Greenway F, et al. Early weight loss with

liraglutide 3.0 mg is a good predictor of clinically meaningful weight loss

after 56 weeks. 51st EASD Annual Meeting 2015.

    2.   American Medical Association A. Declaration to classify obesity as a

disease. Annual Meeting Report. 19 June 2013.

    3.   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; 9:88.

    4.   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.

    5.   Gami AS, Caples SM, Somers VK. Obesity and obstructive sleep apnea.

Endocrinology and Metabolism Clinics of North America. 2003; 32:869-894.

    6.   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.

    7.   Wright SM, Aronne LJ. Causes of obesity. Abdominal Imaging. 2012;

37:730-732.

    8.   WHO. Obesity Data and Statistics (Europe). Available at:

http://www.euro.who.int/en/health-topics/noncommunicable-diseases/obesity/data-and-statistics

(Last accessed 21.08.15).

    9.   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.

    10.  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/0037

80/WC500185786.pdf (Made available: 16 April 2015).

    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

    Melanie Raouzeos

    +45-3075-3479

    mrz@novonordisk.com

    Daniel Bohsen

    +45-3079-6376

    dabo@novonordisk.com

    Frank Daniel Mersebach (US)

    +1-609-235-8567

    fdni@novonordisk.com

SOURCE: Novo Nordisk