Liraglutide Helps Obese Patients Lose Weight in Phase III Study
Treatment improves blood glucose levels, blood pressure, and lipids levels
Results from the phase IIIa SCALE Obesity and Pre-Diabetes trial were presented May 16 at the 23rd Annual Congress of the American Association of Clinical Endocrinologists (AACE), held in Las Vegas, Nevada.
The data showed that after 56 weeks of treatment, liraglutide (Novo Nordisk) — an investigational once-daily glucagon-like peptide-1 (GLP-1) analogue — in combination with a reduced-calorie diet and increased physical activity, provided significantly greater weight loss from baseline compared with placebo (8.0% vs. 2.6%, respectively; P < 0.0001).
The proportions of adults achieving weight loss of 5% or more of their baseline body weight were 64% for the liraglutide 3-mg group and 27% for the placebo group (P < 0.0001). In addition, 33% of adults treated with liraglutide 3 mg achieved weight loss greater than 10% of their baseline body weight compared with 10% of the placebo-treated patients (P < 0.0001).
In conjunction with weight loss, treatment with liraglutide 3 mg significantly reduced waist circumference by 8.19 cm compared with a reduction of 3.94 cm with placebo (P < 0.0001). Further, treatment with liraglutide 3 mg improved blood glucose levels, blood pressure, and lipids levels.
The side effects most often associated with liraglutide 3 mg were nausea and diarrhea, which were mild-to-moderate in severity, occurred shortly after the initiation of liraglutide therapy, and were transient in nature. Gallbladder disorders were reported as 2.7 events per 100 patient-years of exposure (PYE) with liraglutide 3 mg compared with 1.0 event per 100 PYE with placebo. Further, pancreatitis was reported as 0.3 events per 100 PYE with liraglutide 3 mg compared with 0.1 events per 100 PYE with placebo.
In December 2013, a new drug application (NDA) was submitted to the FDA for liraglutide 3 mg for chronic weight management in adults with obesity (BMI ≥30 kg/m2) and in adults who are overweight (BMI ≥ 27 kg/m2) with comorbidities, as an adjunct to a reduced-calorie diet and increased physical activity. This application is currently under review.
Liraglutide is a GLP-1 analogue with 97% similarity to naturally occurring human GLP-1 (a hormone that is released in response to food intake). Like human GLP-1, liraglutide regulates appetite and food intake by decreasing hunger and by increasing feelings of fullness and satiety after eating. The dual actions of liraglutide both appetite and blood glucose regulation (for people with pre-diabetes or type-2 diabetes) may have therapeutic potential for people with obesity, both those with and without diabetes.
The SCALE Obesity and Pre-Diabetes trial was a randomized, double-blind, placebo-controlled study involving non-diabetic subjects with obesity and non-diabetic subjects who were overweight with co-morbidities. A total of 3,731 participants were randomly assigned to treatment with liraglutide 3 mg or placebo in combination with diet and exercise. In addition, participants were further stratified to 56 weeks or 160 weeks of treatment based on their pre-diabetes status at screening.
The trial’s objectives were to demonstrate clinically meaningful weight loss at 56 weeks as well as to investigate the long-term efficacy of liraglutide 3 mg in delaying the onset of type-2 diabetes in participants with pre-diabetes at screening.
Source: Novo Nordisk; May 16, 2014.