Poster Presentation Australian & New Zealand Obesity Society 2015 Annual Scientific Meeting

Weight-lowering effect of liraglutide 3.0 mg in overweight and obese adults: the SCALE obesity and prediabetes trial (#252)

Carel Le Roux , Michel Krempf 1 , Arne Astrup 2 , Ken Fujioka 3 , Frank Greenway 4 , David CW Lau 5 , Rafael Violante Ortiz 6 , John PH Wilding 7 , Christine B Jensen 8 , Alana Philips 9 , Xavier Pi-Sunyer 10
  1. University of Nantes, Nantes, France
  2. University of Copenhagen, Copenhagen, Denmark
  3. Scripps Clinic, La Jolla, CA, USA
  4. Louisiana State University, Baton Rouge, LA, USA
  5. University of Calgary, Calgary, AB, Canada
  6. Instituto Mexicano del Seguro Social, Ciudad Madero, México
  7. University of Liverpool, Liverpool, UK
  8. Novo Nordisk A/S, Søborg, Denmark
  9. Novo Nordisk Pharmaceuticals, Sydney, NSW, Australia
  10. Columbia University, New York, NY, USA

Introduction: The SCALE Obesity and Prediabetes trial (NCT01272219) investigated the efficacy and safety of liraglutide 3.0 mg for weight management as adjunct to a 500 kcal/day deficit diet and exercise programme.

Methods: Adults with BMI ≥27 kg/m² and ≥1 comorbidity or with BMI ≥30 kg/m² were randomised 2:1 to once-daily liraglutide 3.0 mg (n=2487) or placebo (n=1244). Data are observed means for the full analysis set with LOCF at week 56, unless stated otherwise. Statistical analyses report estimated treatment differences (ETD; ANCOVA, continuous variables) or odds ratios (logistic regression, categorical). Baseline BMI subgroups were ≤29.9, 30–34.9, 35–39.9 and ≥40 kg/m².

Results: Baseline characteristics were: mean age 45 years, 79% female, mean body weight (BW) 106 kg, mean BMI 38 kg/m² and 61% with prediabetes. A total of 92% of individuals on liraglutide lost BW vs 65% on placebo. Completers on liraglutide (n=1789, 72%) lost 9.2% (9.7 kg) of their BW vs 3.5% (3.8 kg) on placebo (n=801, 64%; ETD –5.7%, p<0.0001). In total, 73% of completers on liraglutide lost ≥5% BW vs 35% on placebo. WL of >10% occurred in 41% of completers on liraglutide vs 14% on placebo vs placebo-treated individuals. Overall, WL with liraglutide was similar in those with and without prediabetes at screening (8.0% vs 7.9%, respectively, p=0.59) and across baseline BMI subgroups (interaction between BMI subgroup and treatment for relative WL (%): p=0.054 and absolute WL (kg): p=0.54). Non-completion was mainly due to GI AEs (liraglutide group) and lack of efficacy (placebo group).

Conclusion: Liraglutide 3.0 mg, as adjunct to diet and exercise, induced significant WL compared to placebo. WL with liraglutide was independent of both baseline prediabetes status and baseline BMI. Liraglutide 3.0 mg was generally well tolerated and gastrointestinal disorders were the most commonly reported AEs. No new safety signals emerged.