New phase 3a liraglutide 3 mg data showed weight-loss efficacy across a range of baseline BMI categories, and significant improvements in health-related quality of life
BOSTON, Nov. 4, 2014 /PRNewswire/ -- Today, new data from the phase 3a SCALE™ (Satiety and Clinical Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic people) Obesity and Pre-diabetes trial were presented at ObesityWeek 2014, the 2nd annual combined congress of the American Society for Metabolic and Bariatric Surgery and The Obesity Society. In adults with obesity, weight loss with liraglutide 3 mg treatment, in combination with a reduced-calorie diet and physical activity, was similar across a range of baseline body mass index (BMI) subgroups from overweight to Class III obesity, at 56 weeks (P=0.054, %; P=0.54).1 Adults treated with liraglutide 3 mg who completed the 56-week trial demonstrated significantly greater weight loss of 9.2% compared with placebo (3.5%, estimated difference [ED] 5.7%, P<0.0001).1 Weight loss with liraglutide 3 mg as an adjunct to a reduced-calorie diet and physical activity was associated with improved health-related quality of life (HRQoL).2
Treatment with liraglutide 3 mg provided significantly greater weight loss of 8% from baseline compared with 2.6% with placebo (P<0.0001) at 56 weeks,2 independent of baseline BMI (≤29.9 kg/m2 [-7.5% liraglutide 3 mg vs. -0.9% placebo], 30–34.9 [-8.3% vs. -2.6%], 35–39.9 [-9.3% vs. -3.4%] and ≥40 [-7.4% vs. -2.8%], all P<0.0001).3 In addition, weight loss with liraglutide 3 mg was independent of pre-diabetes status at screening (-8.0% vs. -7.9%, P=0.59).1 All treatment groups followed a reduced-calorie diet and an increased physical activity program.1 A larger proportion of adults treated with liraglutide 3 mg completed the 56-week trial compared with those on placebo (72% vs. 64%).1
"Obesity is more than a disease of excess weight," said Dr. Ken Fujioka, Department of Nutrition and Metabolic Research, Scripps Clinic, La Jolla, California, and a SCALE™ clinical trial investigator. "We know that people with obesity may experience increased physical and mental health problems, as well as a reduced quality of life. It is encouraging to see data suggesting that the weight-loss benefits of liraglutide 3 mg are associated with improved health-related quality of life for people with obesity."
Three questionnaires were used in the SCALE™ Obesity and Pre-diabetes trial to assess health-related outcomes: Impact of Weight on Quality of Life-Lite (IWQoL), Short-Form (36) Health Survey (SF-36) and Treatment Related Impact Measure-Weight (TRIM-W).2 Improvements in HRQoL were seen in all three questionnaires and greater weight loss led to greater improvements in HRQoL scores.2
Weight loss associated with liraglutide 3 mg was accompanied by improvements in IWQoL-Lite total score (10.6±13.3) compared with placebo (7.6±12.8; ED 3.1 [2.2;4.0], P<0.0001), mostly due to improved physical function, and the total TRIM-Weight score (ED 2.1 [1.3;3.0], P<0.0001).2 In addition, the SF-36 overall physical health and overall mental health scores (ED 1.7 [1.2;2.2], P<0.0001; ED 0.9 [0.3;1.5], P=0.003) and all domain scores of the IWQoL-Lite and SF-36 improved with liraglutide 3 mg, compared with placebo.2
Obesity is a disease that requires chronic management.4-6 It is a complex and multifactorial 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 health care systems.8-10 In the United States, approximately one-third of adults, or nearly 80 million adults, live with obesity.11
About SCALE™ Obesity and Pre-diabetes
The SCALE™ Obesity and Pre-diabetes trial is a randomised, double-blind, placebo-controlled, multinational trial in non-diabetic adults with obesity and non-diabetic adults who are overweight with comorbidities. There were 3,731 participants randomised to treatment with liraglutide 3 mg or placebo in combination with a reduced-calorie diet and physical activity. In addition, participants were further stratified to 56 weeks or 160 weeks of treatment based on pre-diabetes status at screening.3
The objectives of this trial were to demonstrate clinically meaningful weight loss at 56 weeks, as well as to investigate the long-term efficacy of liraglutide 3 mg to delay the onset of type 2 diabetes in participants with pre-diabetes at screening.3
It is the largest of the phase 3a trials in the SCALE™ clinical development programme, which encompassed more than 5,000 adults with obesity or adults who are overweight with comorbidities.3
About liraglutide 3 mg
Liraglutide 3 mg is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1,12 a hormone that is released in response to food intake. Like human GLP-1, liraglutide 3 mg regulates appetite and food intake by decreasing hunger and increasing feelings of fullness and satiety after eating.13
Liraglutide 3 mg is an investigational product and is not approved by the FDA or European Medicines Agency (EMA).
About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately 40,700 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.com.
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1 Greenway F, Le Roux C, Lau D, et al. Additional analyses of the weight-lowering efficacy of liraglutide 3.0 mg in overweight and obese adults: the SCALE™ obesity and pre-diabetes, a randomized, double-blind and placebo-controlled trial. Paper presented at: Obesity Week 2014, the 2nd Annual Congress of The American Society for Metabolic and Bariatric Surgery and The Obesity Society. November 2-7,2014;Boston, MA.
2 Fujioka K, Astrup A, Greenway F, et al. Liraglutide 3.0 mg reduces body weight and improves Health-Related Quality of Life (HRQoL) in overweight or obese adults without diabetes the SCALE™ obesity and pre-diabetes, a randomized, double-blind and placebo-controlled trial. Paper presented at: Obesity Week 2014, the 2nd Annual Congress of The American Society for Metabolic and Bariatric Surgery and The Obesity Society. November 2-7,2014;Boston, MA.
3 Data on file. Novo Nordisk Inc; Plainsboro, NJ.
4 American Medical Association. Business of the American Medical Association House of Delegates 2013 Annual Meeting annotated reference committee reports: reference committee D. http://www.ama-assn.org/assets/meeting/2013a/a13-addendum-refcomm-d.pdf. Approved June 8, 2014. Accessed September 8, 2014.
5 Mechanick JI, Garber AJ, Handelsman Y, Garvey WT. American Association of Clinical Endocrinologists' position statement on obesity and obesity medicine. Endocr Pract. 2012;18(5):642-648.
6 Hill JO. Dealing with obesity as a chronic disease. Obes Res. 1998;6(S1):34S-38S.
7 Wright SM, Aronne LJ. Causes of obesity. Abdom Imaging. 2012; 37(5):730-732.
8 World Health Organization. Fact sheet no. 311: obesity and overweight. http://www.who.int/mediacentre/factsheets/fs311/en/. Updated August 2014. Accessed August 11, 2014.
9 Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Economics. 2012;31(1):219-230.
10 Wang Y, McPherson K, Marsh T, Gortmaker SL, Brown M. Health and economic burden of the projected obesity trends in the USA and UK. Lancet. 2011;378(9793):815-825.
11 Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014;311(8):806-814.
12 Russell-Jones D, Gough S. Recent advances in incretin-based therapies. Clin Endocrinol. 2012;77(4):489-499.
13 Flint A, Raben A, Ersbøll AK, Holst JJ, Astrup A. The effect of physiological levels of glucagon-like peptide-1 on appetite, gastric emptying, energy and substrate metabolism in obesity. Int J Obes Relat Metab Disord. 2001;25(6):781-792.
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