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

Liraglutide 3.0 mg improves body weight and cardiometabolic risk factors in overweight or obese adults without diabetes: the SCALE Obesity and Prediabetes randomised, double-blind, placebo-controlled 56-week trial (#57)

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

Objective: Determine the effects of liraglutide with diet and exercise, on cardiometabolic risk factors in obese adults.

Design and intervention: Multicentre placebo-controlled double blind trial, with randomisation 2:1 to liraglutide 3.0 mg or placebo, stratified by pre-diabetes status. All participants received a structured diet (500 kcal/day deficit) and exercise program.

Participants: 3731 non-diabetic individuals (age >18 years, BMI ≥27 kg/m2 with comorbidities, or ≥30 kg/m2) were randomised to either liraglutide 3.0 mg (n=2487) or placebo (n=1244).

Outcome measures (Week 56): Primary – weight loss; Secondary – waist circumference and other cardiometabolic risk factors. Data are estimated treatment differences (ETD) or relative difference (lipids) from model-adjusted data (ANCOVA/logistic regression) using the full analysis set (n=3662), last observation carried forward.

Results: Baseline characteristics: 45.1 years, 78.5% female, weight 106.2 kg, BMI 38.3 kg/m2, 61.2% pre-diabetes). Liraglutide 3.0 mg compared with placebo induced: greater decreases in weight (8.0% vs. 2.6%, ETD: -5.4% [95%CI: ‑5.8; -5.0]; p<0.0001), waist (‑4.2 [-4.7; -3.7] cm) and diastolic/systolic blood pressure (-2.8/-0.9 [‑3.6; -2.1/-1.4; -0.4] mmHg) (all p<0.001); increase in pulse (2.4 [1.9; 3.0] beats/min, p<0.0001); decreases in glucose (-0.38 [-0.42; -0.35] mmol/L), HbA1c (-0.23% [-0.25%; -0.21%]), triglycerides (-9% [-12%; -7%]), total (-2% [‑3%; ‑1%]), VLDL (-9% [‑11%; -7%]) [all p<0.0001], and LDL (-2% [-4%; -1%]) cholesterol and increase in HDL cholesterol (+2% [1%; 3%]) [both p<0.01]; improved hsCRP (-30% [‑34%; ‑26%]), PAI-1 (-21% [-26%; -17%]) and adiponectin (+8% [5%; 12%]) [all p<0.0001]) occurred.

Conclusion: Over 56 weeks, added to diet and exercise, liraglutide 3.0 mg reduced weight and multiple cardiometabolic risk factors compared with placebo.