Oral Presentation Australian & New Zealand Obesity Society 2014 Annual Scientific Meeting

Efficacy and safety of liraglutide 3.0 mg for weight management in overweight and obese adults: the SCALE Obesity and Prediabetes, a randomised, double-blind and placebo-controlled trial (#56)

Joseph Proietto 1 , Carel W le Roux 2 , Xavier Pi-Sunyer 3 , Arne Astrup 4 , Ken Fujioka 5 , Frank Greenway 6 , Alfredo Halpern 7 , David CW Lau 8 , Rafael Violante Ortiz 9 , Alana Philips 10 , Søren Kruse Lilleøre 11 , John Wilding 12
  1. Endocrinology Department, Austin Health Repatriation Hospital, Heidelberg West, Vic, Australia
  2. Diabetes Complications Research Centre, University College Dublin, Dublin, Ireland
  3. St Luke’s – Roosevelt Hospital Center, Columbia University, New York, NY, USA
  4. Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark
  5. Division of Endocrinology, Department of Nutrition and Metabolic Research, Scripps Clinic, La Jolla, CA, USA
  6. Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA, USA
  7. Obesity & Metabolic Syndrome Unit, Division of Endocrinology & Metabolism, Hospital das Clínicas, University of São Paulo Medical School, São Paulo, Brazil
  8. Departments of Medicine and Biochemistry & Molecular Biology, University of Calgary, Calgary, Alberta, Canada
  9. Departamento Endocrinología, Instituto Mexicano del Seguro Social, Hospital Regional num. 6, Madero, Tamaulipas, Mexico
  10. Novo Nordisk Pharmaceuticals, Sydney, NSW, Australia
  11. Novo Nordisk A/S, Søborg, Denmark
  12. Department of Obesity and Endocrinology, University Hospital Aintree, Liverpool, UK

The 56-week efficacy and safety of liraglutide 3.0 mg, as adjunct to diet and exercise, were investigated in overweight and obese individuals without type 2 diabetes (T2D). Adults (BMI ≥27 kg/m2 with comorbidities or ≥30 kg/m2) were randomised 2:1 to once-daily subcutaneous liraglutide or placebo plus diet (500 kcal/day deficit) and exercise. 3731 individuals were randomised (age 45.1±12.1 years, body weight 106.2±21.4 kg, BMI 38.3±6.4 kg/m2, 61.2% with prediabetes). Liraglutide was superior to placebo on all weight loss-related parameters (Table) and improved glycaemia, blood pressure and lipids. Weight loss was independent of pre-treatment prediabetes status and BMI. The most common adverse events (AEs) with liraglutide were early-onset nausea and diarrhoea (mostly mild/moderate and transient). Gallbladder disorders and pancreatitis were more common with liraglutide (2.7 and 0.3 events/100 patient-years of exposure [PYE], respectively) than with placebo (1.0 and 0.1 events/100 PYE). AE withdrawal was <10% in both groups. The safety profile was generally consistent with previous trials with liraglutide for T2D. In conclusion, liraglutide 3.0 mg, as adjunct to diet and exercise, was efficacious and generally well tolerated.

Table – Change from baseline to week 56, full analysis set, last observation carried forward

Liraglutide (n=2432)

Observed mean



Observed mean

Estimated treatment-difference/Odds ratio

[95% CI]

Weight loss (%)*



-5.4 [-5.8;-5.0] p<0.0001**

5% responders (%)*



 4.8 [4.1;5.6] p<0.0001***

10% responders (%)*



 4.3 [ 3.5;5.3] p<0.0001***

Waist circumference (cm)



-4.2 [-4.7;-3.7] p<0.0001**

BMI (kg/m2)



-2.0 [-2.2;-1.9] p<0.0001**

*Co-primary endpoints tested hierarchically