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

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 (#74)

Ian Caterson 1 , Patrick O'Neil 2 , Ken Fujioka 3 , Rafael Violante Ortiz 4 , Christine B Jensen 5 , Alana Philips 6 , Arne Astrup 7
  1. Boden Institute of Obesity Nutrition Exercise and Eating Disorders, University Of Sydney, NSW, Australia
  2. Medical University of South Carolina, Charleston, SC, USA
  3. Division of Endocrinology, Scripps Clinic, La Jolla, California, USA
  4. Departamento Endocrinología, Instituto Mexicano del Seguro Social, Hospital Regional num. 6, Cd.Madero, Tam, Mexico
  5. Novo Nordisk A/S, Soeborg, Denmark
  6. Novo Nordisk Pharmaceuticals, Sydney, NSW, Australia
  7. Department of Nutrition Exercise and Sports, University of Copenhagen, Copenhagen, Denmark

Introduction: SCALE Obesity and Prediabetes (NCT01272219), a 56-week, randomised, double-blind, placebo-controlled trial evaluated the efficacy and safety of liraglutide in weight management. This post-hoc analysis compared key outcomes of responders (≥5% weight loss [WL] from baseline at week [W] 56) vs non-responders (<5% WL from baseline at W56).

Methods: Overweight/obese individuals (BMI ≥27 kg/m2 with ≥1 comorbidity or ≥30 kg/m2) without T2D were randomised 2:1 to liraglutide 3.0 mg (n=2487) or placebo (n=1244) as an adjunct to diet and exercise. Change from baseline data are LS means with LOCF.

Results: Mean overall baseline characteristics: age 45 years, 79% female, body weight 106 kg, BMI 38 kg/m2. At W56, significantly more individuals on liraglutide vs. placebo were responders (63.2% vs 27.1%; p<0.0001). WL in responders vs non-responders was liraglutide: -11.7 vs ­1.7%, placebo: -10.0 vs 0.1%. Responders had greater improvements than non-responders across a range of outcomes, including glycaemia, cardiometabolic and quality of life outcomes. Reduction in FPG was greater with liraglutide vs placebo for responders (-0.46 vs -0.16 mmol/L, respectively) and non-responders (-0.28vs. +0.06 mg/dL, respectively), and for systolic blood pressure with liraglutide vs placebo (responders: -5.5 vs -3.4 mmHg, respectively; non-responders: -2.0 vs -0.8 mmHg, respectively). Gastrointestinal adverse events (AE) were the most common AEs, occurring with similar frequency in responders and non-responders (liraglutide 69.2 and 67.2%; placebo 44.4 and 39.6%, respectively). Gallbladder events were more common in liraglutide responders than placebo responders (3.4 vs 1.2 events/100 PYE, respectively) but similar in both non-responder arms (1.2 vs 1.1 events/100 PYE, respectively).

Conclusion: More individuals on liraglutide 3.0 mg vs. placebo had WL ≥5% at W56, with greater mean WL in responders vs. non-responders. In both arms, responders had greater improvements in glycaemic and cardiometabolic outcomes. AE rates were generally equivalent in responders and non-responders.