Diabetologie und Stoffwechsel 2015; 10 - LB6
DOI: 10.1055/s-0035-1556575

Additional analyses of the weight-lowering efficacy of liraglutide 3.0 mg in overweight and obese adults: the SCALE obesity and prediabetes randomized trial

F Greenway 1, C le Roux 2, D Lau 3, A Astrup 4, K Fujioka 5, A Halpern 6, M Krempf 7, RV Ortiz 8, J Wilding 9, CB Svendsen 10, CB Jensen 10, X Pi-Sunyer 11, J Kienhöfer 12, A Segner 13
  • 1Pennington Biomedical Research Center, Baton Rouge, United States
  • 2University College Dublin, Dublin, Ireland
  • 3University of Calgary, Calgary, Canada
  • 4University of Copenhagen, Copenhagen, Denmark
  • 5Scripps Clinic, La Jolla, United States
  • 6University of São Paulo Medical School, São Paulo, Brazil
  • 7Université de Nantes, Nantes, France
  • 8Instituto Mexicano del Seguro Social, Ciudad Madero, Mexico
  • 9University of Liverpool, Liverpool, United Kingdom
  • 10Novo Nordisk A/S, Søborg, Denmark
  • 11Columbia University, New York, United States
  • 12Novo Nordisk Pharma GmbH, Mainz, Germany
  • 13Praxis Segner/Dr. Braun/Kirsch, Oberwürzbach, Germany

Background: Safety and efficacy of liraglutide 3.0 mg, adjunct to 500 kcal/day dietary deficit and exercise, for weight management, was investigated.

Methods: Adults (BMI ≥27 kg/m2 with ≥1 comorbidity or ≥30 kg/m2) were randomized 2:1 to once-daily s.c. 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 LOCF at week 56, unless stated otherwise. Statistical analyses are estimated treatment differences (ETD; ANCOVA, continuous variables) or odds ratios (OR; logistic regression, categorical). Baseline BMI subgroups: ≤29.9, 30 – 34.9, 35 – 39.9, ≥40 kg/m2 . Baseline characteristics: age 45.1 years, 78.5% female, body weight (BW) 106.2 kg, BMI 38.3 kg/m2, 61.2% with prediabetes.

Results: 92% on liraglutide lost BW vs. 65% on placebo). BW loss ≥5% occurred in 63% (liraglutide) vs. 27% (placebo; OR 4.8, p < 0.0001). BW loss > 10% and > 15% with liraglutide vs. placebo was seen in 33% vs. 11% (OR 4.3, p < 0.0001) and 14% vs. 3.5% (OR 4.9, p < 0.0001). Completers on liraglutide (n = 1789, 72%) lost 9.2% (9.7 kg) of BW vs. 3.5% (3.8 kg) on placebo (n = 801, 64%; ETD -5.7%, p < 0.0001). BW loss with liraglutide was similar in those with/without prediabetes at screening (-8.0% vs. -7.9%, p = 0.59) and across baseline BMI subgroups (p = 0.054,%; p = 0.54,kg).

Conclusions: Liraglutide was well tolerated: safety profile was consistent with previous trials; gastrointestinal disorders were most common. Liraglutide 3.0 mg, induced significant weight loss compared with placebo, independent of prediabetes status and BMI.

Joachim Kienhöfer meldet einen potenziellen Interessenkonflikt an.
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