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DOI: 10.1055/s-0035-1549086
Efficacy and safety of liraglutide 3.0 mg for weight management in overweight and obese adults: the SCALE™ Obesity and Prediabetes, a randomised, double-blind and placebo-controlled trial
Introduction:
The 56-week efficacy and safety of liraglutide 3.0 mg, as adjunct to diet and exercise, was investigated in overweight and obese individuals without T2DM.
Methods:
Adults (BMI ≥27 kg/m2 with comorbidities or ≥30 kg/m2) were randomised 2:1 to once-daily subcutaneous liraglutide or placebo plus diet (500 kcal/day deficit) and exercise. Randomisation was stratified by prediabetes status (ADA 2010) and BMI. Clinicaltrials.gov ID: NCT01272219.
Results:
3731 individuals were randomised (age 45.1 ± 12.1 years, body weight 106.2 ± 21.4 kg, BMI 38.3 ± 6.4 kg/m2, 61.2% with prediabetes). Liraglutide was superior to placebo on all weight loss (WL) related parameters (Table) and improved glycaemia, blood pressure and lipids (not shown). WL was independent of pre-treatment prediabetes status and BMI. The most common adverse events (AEs) with liraglutide were early onset nausea and diarrhoea. Most events were mild/moderate and transient. Gallbladder disorders and pancreatitis were more common with liraglutide (2.7 and 0.3 events/100 patient years of exposure [PYE], respectively) than with placebo (1.1 and 0.1 events/100 PYE). AE withdrawal was < 10% in both groups. The safety profile was generally consistent with that of previous clinical trials with liraglutide for T2DM.
Liraglutide LS-mean [95% CI] |
Placebo LS-mean |
Estimated treatment- difference/Odds ratio |
|
1. WL (%)* |
-8.0 |
-2.6 |
-5.4 [-5.8; -5.0] p < 0.0001** |
2. 5% responders (%)* |
63.5 |
26.6 |
4.8 [4.1; 5.6] p < 0.0001*** |
3. 10% responders (%)* |
32.8 |
10.1 |
4.3 [ 3.5; 5.3] p < 0.0001*** |
Waist circumference (cm) |
-8.2 |
-4.0 |
-4.2 [-4.7; -3.7] p < 0.0001** |
BMI (kg/m2) |
-3.0 |
-1.0 |
-2.0 [-2.2; -1.9] p < 0.0001** |
*Co-primary-endpoints tested in hierarchical order **ANCOVA ***Logistic-regression |
Conclusion: Liraglutide 3.0 mg, as adjunct to diet and exercise, was efficacious and generally well tolerated.