New data from the phase 3a SCALE(TM) (Satiety and Clinical Adiposity: Liraglutide Evidence in Non-Diabetic and Diabetic adults) Obesity and Prediabetes three-year trial extension was presented at the 3rd annual combined congress of the American Society for Metabolic and Bariatric Surgery and The Obesity Society.
The extension part of the trial (n=2,254 adults with obesity or who were overweight with comorbidities and had prediabetes at baseline), demonstrated that treatment with Saxenda® (liraglutide 3 mg) in combination with a reduced-calorie diet and increased physical activity resulted in significant and sustained weight loss over the three-year span, compared with a reduced-calorie diet and increased physical activity alone.
At week 160, those randomised to treatment with Saxenda® (n=1,505) achieved an average body weight loss of 6.1% from baseline, compared with 1.9% for placebo treatment (n=749; p<0.0001); 49.6% of adults treated with Saxenda® achieved ≥5% weight loss, compared to 23.7% of adults on placebo (p<0.0001). In addition, 24.8% lost more than 10% of their body weight when treated with Saxenda® compared to 9.9% with placebo (p<0.0001).
The extension met its primary endpoint, demonstrating that ongoing treatment with Saxenda® in combination with reduced-calorie diet and increased physical activity delayed the onset of type 2 diabetes, compared with placebo.
“Losing and maintaining weight loss can be very challenging for adults with obesity or who are overweight,” said Professor Carel le Roux, the SCALE™ clinical trial investigator. “These data are very important as they demonstrated the clinical value of Saxenda® over a period of three years.”
Withdrawal rates due to adverse events were 13.3% with Saxenda® compared with 6.2% with placebo. Serious adverse events were reported by 15.1% in the Saxenda® group
and 12.9% with placebo. The incidence of gallbladder-related and confirmed pancreatitis events were more frequent with Saxenda® (2.9 events per 100 patient years of observation [PYO] and 0.29/100 PYO, respectively) vs placebo (1.2/100 PYO and 0.13/100 PYO, respectively).
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. In 2011–2012 in the US, approximately 35% of adults, or nearly 80 million adults, live with obesity.
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