Outcomes from the SCALE™ Obesity and Pre-diabetes phase 3a clinical trials are were introduced for the initial time at the 23rd Annual Congress of the American Association of Clinical Endocrinologists recently. Data demonstrated that soon after 56 weeks of therapy, liraglutide 3 mg, in combo with diet and physical activity, provided considerably greater weight reduction of 8 percent (8.4 kg) from baseline in comparison to 2.6 percent (2.8 kg) with placebo (p<0.0001). This is the biggest trial in the SCALE™ programme analyzing liraglutide 3 mg, an investigational once-daily glucagon-like peptide-1 (GLP-1) analogue for weight control.
All therapy arms involved a reduced-calorie diet and enhanced physical exercise. The percentage of adults accomplishing weight loss of 5 % or more of their baseline body weight was 64 % for liraglutide 3 mg treatment in comparison to 28 % for placebo. In addition, 34 % of adults handled with liraglutide 3 mg achieved weight loss higher than 10 % of their baseline body weight in comparison to 10 % for placebo.
It is well-known that a sustained weight reduction of 5 to 10 % provides considerable health advantages for adults with obesity. The high percentage of adults obtaining this clinically significant weight loss is encouraging, especially when observed in combination with the extra benefits beyond weight loss that are also being analyzed with liraglutide 3 mg treatment.
In combination with weight loss, therapy with liraglutide 3 mg considerably decreased waist circumference by -8.18 cm, in comparison to -3.96 cm with placebo. Additionally, therapy with liraglutide 3 mg enhanced lipids levels, blood glucose levels and blood pressure.
The most often claimed side effects related with liraglutide 3 mg therapy were gastrointestinal, which were mild to moderate, took place soon after liraglutide start, and were temporary. Cases of gallbladder disorders and pancreatitis were minimal but greater than in placebo-treated people.
Gallbladder disorders were claimed as 2.8 events per 100 patient-years of subjection (PYE) with liraglutide 3 mg therapy in comparison to 1.1 events per 100 PYE for placebo and pancreatitis as 0.3 events per 100 PYE with liraglutide 3 mg in comparison to 0.2 events per 100 PYE with placebo.
In December 2013, Denmark based Pharmaceutical Company Novo Nordisk submitted a Marketing Authorisation Application (MAA) to the EMA and a NDA to the US FDA for liraglutide 3 mg for chronic weight control in adults who have obesity, or are overweight with comorbidities, as an adjunct to a decreased-calorie diet and enhanced physical exercise. Both the applications are under review process.