Poster Presentation Australian & New Zealand Obesity Society 2016 Annual Scientific Meeting

Liraglutide 3.0 mg in obese/overweight adults with or without prediabetes with baseline BMI <35 vs ≥35 kg/m² in the SCALE Obesity and Prediabetes 56-week randomized, double-blind, placebo-controlled trial (#265)

Joseph Proietto 1 , Xavier Pi-Sunyer 2 , Luc van Gaal 3 , John PH Wilding 4 , Carel W Le Roux 5 , Søren K Lilløre 6 , Birgitte Claudius 6 , Frank Greenway 7 , Cilla Haywood
  1. University of Melbourne, Melbourne, Vic, Australia
  2. Columbia University, New York, NY, USA
  3. Antwerp University Hospital, Antwerp, Belgium
  4. University of Liverpool, Liverpool, UK
  5. University College, Dublin, Ireland
  6. Novo Nordisk A/S, Søborg, Denmark
  7. Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA

Background: SCALE Obesity and Prediabetes (NCT01272219) randomized 3731 subjects (mean age 45 years, male 22%, mean BMI 38 kg/m2, 61% with prediabetes) 2:1 to liraglutide 3.0 mg or placebo (PBO) as adjunct to diet and exercise (D&E) for 56 weeks.

Methods: This post-hoc analysis compared efficacy and safety results for subjects with BMI < vs ≥35 kg/m2 at baseline. The treatment effect of liraglutide across baseline BMI subgroups was evaluated by statistical testing of interaction between treatment and baseline BMI subgroup.

Results: Baseline characteristics were similar between liraglutide and PBO subgroups (BMI< vs ≥35 kg/m²) except for body weight (90.1 and 89.9 kg; 115.1 and 115.0 kg) and prevalence of prediabetes (54.0 and 51.1%; 65.3 and 66.1%); both were higher with BMI ≥35 kg/m². At 56 weeks, greater mean and categorical weight loss were seen with liraglutide vs PBO in both subgroups (mean: −8.2 and −7.9%; −2.7 and −2.6%) as well as greater improvements in systolic BP, FPG, and IWQoL-Lite total score. These treatment effects of liraglutide were all independent of baseline BMI (< vs ≥35 kg/m²; p>0.05), except for the IWQoL-Lite physical function sub-score, which improved more with BMI ≥35 kg/m² (p=0.04).

Adverse events (AEs) and serious AEs were generally comparable across BMI subgroups. In both liraglutide subgroups (BMI< or ≥35 kg/m²), more subjects reported nausea (40 vs 40%) than PBO (15 vs 15%). Gallbladder disorders were similar in liraglutide subgroups (18 [2.1%] vs 37 [2.3%] subjects) but higher than PBO (3 [0.7%] vs 7 [0.9%] subjects). Similar results were seen for adjudicated events of acute pancreatitis (liraglutide: 2 [0.2%] vs 5 [0.3%] subjects; PBO: 0 vs 1 [0.1%] subject).

Conclusions: The effects of liraglutide 3.0 mg, as adjunct to D&E, on body weight, metabolic control and safety were similar in subjects with baseline BMI < and ≥35 kg/m².