Results from the SCALE Obesity and Pre-diabetes phase 3a trial will be presented for the first time at the 23rd Annual Congress of the American Association of Clinical Endocrinologists (AACE). Data showed that after 56 weeks of treatment, liraglutide 3 mg, in combination with diet and exercise, provided significantly greater weight loss of 8% from baseline compared to 2.6% with placebo (p<0.0001). This is the largest trial in the SCALE program investigating liraglutide 3 mg, an investigational once-daily glucagon-like peptide-1 (GLP-1) analogue for weight management.All treatment groups included a reduced-calorie diet and increased physical activity. The proportion of adults achieving weight loss of 5% or more of their baseline body weight was 64% for liraglutide 3 mg treatment compared to 27% for placebo (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 to 10% for placebo (p<0.0001).
“It is known that a sustained weight loss of 5–10% provides significant health benefits for adults with obesity,” said Xavier Pi-Sunyer, co-director of The New York Obesity Nutrition Research Center and lead investigator of the trial. “The high proportion of people achieving this clinically meaningful weight loss is encouraging, particularly when seen in combination with the additional benefits beyond weight loss that are also being evaluated with liraglutide 3 mg treatment.”
In conjunction with weight loss, treatment with liraglutide 3 mg significantly reduced waist circumference by –8.19 cm, compared to –3.94 cm with placebo (p<0.0001). Furthermore, treatment with liraglutide 3 mg improved blood glucose levels, blood pressure and lipids levels.
The most frequently reported side effects associated with liraglutide 3 mg treatment were gastrointestinal (nausea and diarrhea), which were mild to moderate, occurred shortly after liraglutide initiation, and were transient. Incidences of gallbladder disorders and pancreatitis were low but higher than in placebo-treated individuals. Gallbladder disorders were reported as 2.7 events per 100 patient-years of exposure (PYE) with liraglutide 3 mg treatment compared to 1.0 events per 100 PYE for placebo and pancreatitis as 0.3 events per 100 PYE with liraglutide 3 mg compared to 0.1 events per 100 PYE with placebo.
In December 2013, Novo Nordisk submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for liraglutide 3 mg for chronic weight management in adults with obesity (BMI=30 kg/m2) and adults who are overweight (BMI=27 kg/m2) with comorbidities, as an adjunct to a reduced-calorie diet and increased physical activity. These applications are under review.
Date: May 16, 2014
Source: NovoNordisk
