Liraglutide 3.0 mg improves body weight and cardiometabolic risk factors in overweight or obese adults without diabetes: the scale obesity and prediabetes randomized, double-blind, placebo-controlled 56-week trial
C. Le Roux; A. Astrup; K. Fujioka; F. L. Greenway; A. Halpern; M. Krempf; D. C. Lau; R. V. Ortiz; J. Wilding; C. B. Jensen; et al.
Year of publication
Endocrine reviews. Conference: 96th annual meeting and expo of the endocrine society, ENDO 2014. Chicago, IL united states. Conference start: 20140621. Conference end: 20140624. Conference publication: (var.pagings)
Obesity is a chronic disease associated with multiple progressive comorbidities including hypertension, dyslipidemia, type 2 diabetes and atherosclerosis. A 5‐10% weight loss has been shown to improve weight‐related comorbidities. This phase 3 trial investigated the effects of liraglutide 3.0 mg, as adjunct to diet and exercise, on weight loss (primary endpoint) and cardiometabolic risk factors (waist circumference, blood pressure, triglycerides, HDL cholesterol and other biomarkers). Individuals (BMI >27 kg/m2 with >1 comorbidity or >30 kg/m2) were advised on a 500 kcal/day deficit diet and exercise program and randomized 2:1 to once daily sc liraglutide 3.0 mg (n=2487) or placebo (n=1244). Randomization was stratified by prediabetes status (ADA 2010) and BMI. Data are shown for the full analysis set (exposed individuals with >1 postbaseline assessment) with LOCF. The trial has an ongoing 2‐year extension for participants with prediabetes. Clinicaltrials.gov ID: NCT01272219. Baseline characteristics were: age 45.1 years, 78.5% female, body weight 106.2 kg, BMI 38.3 kg/m2, 61.2% with prediabetes). At week 56, individuals treated with liraglutide 3.0 mg (n=2437) achieved more weight loss (8.0%, least square mean) than those treated with placebo (n=1225; 2.6%) (estimated treatment difference [ETD] ‐5.4% [95%CI ‐5.8; ‐5.0]; p