Diabetologie und Stoffwechsel 2015; 10 - LB5
DOI: 10.1055/s-0035-1556574

Efficacy and safety of liraglutide 3.0 mg in adult overweight and obese weight loss responders without diabetes: results of the randomised, double-blind, placebo-controlled 56-week SCALE Obesity and Prediabetes trial

P O'Neil 1, K Fujioka 2, R Violante Ortiz 3, B Claudius 4, C Jensen 4, A Astrup 5, J Kienhöfer 6, A Hamann 7
  • 1Medical University of South Carolina, Charleston, United States
  • 2Scripps Clinic, La Jolla, United States
  • 3Instituto Mexicano del Seguro Social, Tam, Mexico
  • 4Novo Nordisk A/S, Soborg, Denmark
  • 5Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark
  • 6Novo Nordisk Pharma GmbH, Mainz, Germany
  • 7Medizinischen Klinik IV/Hochtaunus-Kliniken gGmbH, Bad Homburg, Germany

The randomized, double-blind, placebo-controlled trial SCALE Obesity and Prediabetes (NCT01272219) evaluated the efficacy and safety of liraglutide 3.0 mg in weight management. Overweight/obese individuals (BMI ≥27 kg/m2 with ≥1 comorbidity or ≥30 kg/m2) without T2D (age 45 years, 79% female, body weight 106 kg, BMI 38 kg/m2) were randomized 2:1 to liraglutide 3.0 mg (n = 2487) or placebo (n = 1244) plus diet and exercise. This analysis compared outcomes of responders (≥5% weight loss [WL] from baseline at week 56) vs. non-responders (< 5% WL).

At week 56, significantly more liraglutide than placebo subjects were responders (63.2% vs. 27.1%; p < 0.0001). Weight change (responders vs. non-responders) was -11.7% vs. -1.7% with liraglutide and -10.0% vs. +0.1% with placebo, respectively. Responders had greater improvements than non-responders across various efficacy outcomes (e.g. glycemic, cardiometabolic and HRQoL). Liraglutide was associated with a greater reduction in FPG vs. placebo for both responders (-8.3 vs. -2.8 mg/dl) and non-responders (-5.0 vs. +1.1 mg/dl), and also a greater reduction in systolic blood pressure in both responders and non-responders. Change in overall physical health scores (SF-36) for liraglutide and placebo were +4.3 vs. +4.1 for responders and +2.1 vs. +1.3 for non-responders, respectively.

AEs were largely equivalent in responders and non-responders. Gastrointestinal AEs were the most common; these were higher with liraglutide than placebo but equivalent in responders (liraglutide: 69.2%; placebo: 44.4%) vs. non-responders (liraglutide: 67.2%; placebo: 39.6%). Mean change in pulse rate was +2.5 vs. -1.6 for responders and +2.9 vs. +0.4 bpm for non-responders for liraglutide and placebo, respectively.

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