Saxendax(R) demonstrated significant improvements in cardiometabolic risk factors over three years compared with placebo

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BOSTON, Apr. 5 /PRNewswire=KYODO JBN/ --

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    Oral Presentation# OR36-1

    Today, new data from the three-year part of the phase 3a SCALE(TM) (Satiety

and Clinical Adiposity - Liraglutide Evidence) Obesity and Prediabetes trial

were presented at the Endocrine Society's 98th Annual Meeting and Expo (ENDO

2016). The three-year part of the trial (n=2,254 adults with obesity or who

were overweight with comorbidities and had prediabetes at baseline), data

demonstrated that 160 weeks of treatment with Saxenda(R) (liraglutide 3 mg)

(n=1,505) in combination with a reduced-calorie diet and increased physical

activity resulted in significant improvements in cardiometabolic risk factors

(such as blood pressure and cholesterol) compared with placebo (reduced-calorie

diet and increased physical activity alone) (n=749).[1]

    At week 160, individuals treated with Saxenda(R) had lost more weight

(6.1%) than those treated with placebo (1.9%) (estimated treatment difference

[ETD] -4.3% [95% CI -4.9; -3.7], p＜0.0001).[1] In addition, treatment with

Saxenda(R) achieved results beyond weight loss including improvements in some

cardiometabolic risk factors such as blood pressure and cholesterol. At week

160, participants randomised to treatment with Saxenda(R)  experienced a

greater reduction in systolic blood pressure compared with placebo (ETD -2.8

mmHg [-3.8; -1.8], p＜0.0001). Those treated with Saxenda(R) also experienced

greater improvements in triglycerides (ETD -6% [-9; -3], p=0.0003) and total

cholesterol levels (ETD -2% [-3; 0], p=0.03) compared with placebo.

Additionally, people treated with Saxenda (R) showed a greater reduction in

mean waist circumference compared with placebo (ETD -3.5 cm [-4.2; -2.8]).

    "We know that weight loss of as little as 5 to 10% in people with obesity

can have an impact on cardiometabolic risk factors," said Dr Ken Fujioka,

Scripps Clinic, San Diego, California, US and a SCALE(TM) clinical trial

investigator. "This is currently the longest weight-management trial with

Saxenda(R), and the observed improvements in blood pressure, lipids and waist

circumference at three years are encouraging."

    In addition, the three-year part of the SCALE(TM) Obesity and Prediabetes

trial met its primary endpoint, demonstrating that continued treatment over

three years with Saxenda (R), in combination with a reduced-calorie diet and

increased physical activity, delayed the onset of type 2 diabetes compared with

placebo.[1]

    Aligned with previous trials, during treatment with Saxenda(R), mean pulse

rate was increased (ETD +2 beats/min [+1.2; +2.7], p＜0.0001). Saxenda(R) was

generally well tolerated, and observed side effects were in line with previous

trials.[2] Over 160 weeks, reports of serious adverse events were higher in

those treated with Saxenda(R) compared with placebo (15.1% vs 12.9%). Rates of

gallbladder-related adverse events and confirmed acute pancreatitis were low,

but more frequent in those treated with Saxenda(R) (2.9 events per 100

patient-years of observation [PYO] and 0.29/100 PYO, respectively) vs placebo

(1.2/100 PYO and 0.13/100 PYO, respectively). The frequency of adjudicated

major adverse cardiovascular events was low, and comparable in those treated

with Saxenda(R) and placebo (0.19 vs 0.20 events/100 PYO).[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 3 clinical trial programme.

    Saxenda(R) is approved in the US as an adjunct to a reduced-calorie diet

and increased physical activity for chronic weight management in adults with

obesity (BMI of greater than or equal to30 kg/m2) or who are overweight (BMI of

greater than or equal to27 kg/m2) in the presence of at least one

weight-related comorbid condition (e.g. hypertension, dyslipidaemia, type 2

diabetes).[11]

    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 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) 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

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 41,000 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

    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

    Kasper Veje     

    +45-3079-8519     

    kpvj@novonordisk.com

    References

    1.    Fujioka K GF, Krempf M, le Roux C, Vettor R, Shapiro Manning L,

Lilleore S,  Astrup A. Liraglutide 3.0 mg Reduces Body Weight and Improves

Cardiometabolic Risk Factors in Adults with Obesity or Overweight and

Prediabetes: the SCALE Obesity and Prediabetes Randomized, Double-blind,

Placebo-controlled 3-year Trial. ENDO 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: February 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; 9:88.

    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.   FDA. Saxenda(R) (liraglutide 3 mg) US Prescribing Information.

Available at: http://www.novo-pi.com/saxenda.pdf  Last accessed: February 2016.

SOURCE:  Novo Nordisk