Additional analyses of the weight-lowering efficacy of liraglutide 3.0 mg in overweight and obese adults: the SCALE Obesity and Prediabetes randomised trial — ASN Events
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Additional analyses of the weight-lowering efficacy of liraglutide 3.0 mg in overweight and obese adults: the SCALE Obesity and Prediabetes randomised trial (#10)

Joseph Proietto 1 , Frank Greenway 2 , Carel Le Roux 3 , David CW Lau 4 , Arne Astrup 5 , Ken Fujioka 6 , Alfredo Halpern 7 , Michel Krempf 8 , Rafael Violante Ortiz 9 , John PH Wilding 10 , Christine B Jensen 11 , Sabina Furber 12 , Xavier Pi-Sunyer 13
  1. University of Melbourne, Melbourne, Vic, Australia
  2. Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA
  3. University College, Dublin, Ireland
  4. University of Calgary, Calgary, AB, Canada
  5. University of Copenhagen, Copenhagen, Denmark
  6. Scripps Clinic, La Jolla, CA, USA
  7. University of São Paulo Medical School, São Paulo, Brazil
  8. Université de Nantes, Nantes, France
  9. Instituto Mexicano del Seguro Social, Ciudad Madero, México
  10. University of Liverpool, Liverpool, UK
  11. Novo Nordisk A/S, Søborg, Denmark
  12. Novo Nordisk Pharmaceuticals, Sydney, NSW, Australia
  13. Columbia University, New York, NY, USA

This trial investigated the efficacy and safety of liraglutide 3.0 mg, as adjunct to a 500 kcal/day deficit diet and exercise program, for weight management in obese or overweight individuals without diabetes (Clinicaltrials.gov ID: NCT01272219). Individuals (body mass index [BMI] ≥27 kg/m2 with ≥1 comorbidity or ≥30 kg/m2) were randomised 2:1 to once-daily subcutaneous liraglutide 3.0 mg (n=2487) or placebo (n=1244). Data are observed means for the full analysis set (exposed individuals with ≥1 post-baseline assessment) with last observation carried forward at week 56, unless stated otherwise. Statistical analyses were estimated treatment differences (ED; ANCOVA, continuous variables) or odds ratios (OR; logistic regression, categorical). Baseline BMI subgroups were 27.0–29.9, 30–34.9, 35–39.9 and ≥40 kg/m2.Baseline characteristics: mean age 45.1 years, 78.5% female, body weight 106.2 kg, BMI 38.3 kg/m2, 61.2% with prediabetes.

92% of individuals on liraglutide lost weight vs. 65% on placebo. Weight loss ≥5% occurred in 63% (liraglutide) vs. 27% (placebo; OR 4.8, p<0.0001). Weight loss >10% and >15% with liraglutide vs. placebo was seen in 33% vs. 11% (OR 4.3, p<0.0001) and 14% vs. 4% (OR 4.9, p<0.0001), respectively. Completers on liraglutide (n=1789, 72%) lost 9% (10 kg) of weight vs. 5% (4 kg) on placebo (n=801, 64%; ED ‑6%, p<0.0001). Weight loss with liraglutide was similar in those with/without prediabetes at screening (‑8% vs. ‑8%, p=0.59) and similar across baseline BMI subgroups (p=0.054, %; p=0.54, kg).

Liraglutide was generally well tolerated: the safety profile was consistent with previous trials with liraglutide 3.0 mg; gastrointestinal disorders were most commonly reported.

Liraglutide 3.0 mg, as adjunct to diet and exercise, induced significant weight loss compared to placebo, independent of prediabetes status and baseline BMI.