Novo Nordisk announced results from its Phase 3a trial evaluating liraglutide 3mg, an investigational once-daily glucagon-like peptide-1 (GLP-1) analogue for weight management. Liraglutide regulates appetite and food intake by decreasing hunger and increasing feelings of fullness and satiety after eating.
The SCALE Obesity and Pre-diabetes trial is a randomized, double-blind, placebo controlled trial in non-diabetic obese and overweight patients with comorbidities (N=3,731). Patients were randomized to either liraglutide 3mg or placebo in combination with diet and exercise. In addition, subjects were further stratified to 56 weeks or 160 weeks of treatment based on pre-diabetes status at screening. The objectives of this trial were to demonstrate clinically meaningful weight loss at 56 weeks as well as to investigate the long-term efficacy of liraglutide 3mg to delay the onset of type 2 diabetes in subjects with pre-diabetes at screening.
Results demonstrated that after 56 weeks of treatment, liraglutide in combination with diet and exercise provided significantly greater weight loss of 8% from baseline compared to 2.6% with placebo (P<0.0001). The proportion of adults achieving weight loss of ≥5% of their baseline body weight was 64% for liraglutide compared to 27% for placebo (P<0.0001). In addition, 33% of adults treated with liraglutide achieved weight loss >10% of their baseline body weight compared to 10% for placebo (P<0.0001). In conjunction with weight loss, treatment with liraglutide significantly reduced waist circumference by -8.19 cm, compared to -3.94 cm with placebo (P<0.0001). Furthermore, treatment with liraglutide improved blood glucose levels, blood pressure and lipids levels.
In December 2013, Novo Nordisk submitted a New Drug Application (NDA) to the FDA for liraglutide 3mg for chronic weight management in adults who have obesity (BMI >30 kg/m2), or are overweight (BMI >27 kg/m2) with comorbidities, as an adjunct to a reduced-calorie diet and increased physical activity.
For more information call (800) 727-6500 or visit NovoNordisk.com.