Liraglutide 3.0 mg reduces body weight and improves cardiometabolic risk factors: SCALE obesity and prediabetes randomised, double-blind, placebo-controlled 3-year trial

Type Article

Journal Article


C. W. Le Roux; A. Astrup; F. Greenway; M. Krempf; R. Vettor; L. Shapiro Manning; S. K. Lilleore; K. Fujioka

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Background and aims: Obesity and prediabetes are risk factors for developing T2DM. A 5‐10% weight loss may reduce the risk of developing T2DM. This phase 3 trial investigated effects of liraglutide 3.0 mg, as an adjunct to diet and exercise, in delaying the onset of T2DM (primary endpoint) over 3 years, as well as in improving body weight and cardiometabolic risk factors. Materials and methods: Individuals with overweight or obesity (BMI ≥30 kg/m2 or ≥27 kg/m2 with dyslipidaemia and/or hypertension) were advised on a 500 kcal/day deficit diet and 150 minutes/week physical activity programme and randomised 2:1 to once‐daily s.c. liraglutide 3.0 mg (n=1505) or placebo (n=749). Efficacy data are observed means, with last observation carried forward. Results: Baseline characteristics of the 2254 randomised individuals (mean ±SD) were: age 47.5±11.7 years, 76.0% female, body weight 107.6±21.6 kg, BMI 38.8±6.4 kg/m2. While on treatment, the time to onset of T2DM over 3 years was 2.7 times longer with liraglutide 3.0 mg than with placebo [95%CI 1.9;3.9], corresponding to a hazard ratio of 0.2 (p