Novo Nordisk announced the headline results from the SCALE Obesity and Prediabetes three-year extension trial in adults with obesity or who were overweight with comorbidities, and had prediabetes at baseline. The trial met its primary endpoint, demonstrating that ongoing treatment with Saxenda (liraglutide 3 mg), in combination with a reduced-calorie diet and increased physical activity delayed the onset of type 2 diabetes, compared with placebo (diet and exercise alone).
Over the course of this 160-week, randomised, blinded phase 3a trial, the time to onset of type 2 diabetes was 2.6 times longer with Saxenda compared with placebo treatment. In addition, the risk of developing type 2 diabetes was reduced by approximately 80% and statistically significant (p<0.0001) for those being treated with Saxenda.
“People with obesity are at an increased risk of developing type 2 diabetes, which is a serious disease,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer. “We are encouraged by these three-year data demonstrating that Saxenda can help to delay the onset of type 2 diabetes, in addition to providing sustained long-term weight loss.”
At 160 weeks, Saxenda provided an average body weight loss of 6.1% from baseline, compared with 1.8% for placebo treatment (p<0.0001), both in combination with a reduced calorie diet and increased physical activity. 49.6% of people treated with Saxenda achieved a clinically meaningful weight loss of at least 5% of their baseline body weight, compared with 23.4% on placebo treatment; 24.3% lost more than 10% of their body weight when treated with Saxenda compared to 9.4% with placebo.
In the trial, Saxenda was generally well tolerated and no new safety issues were identified. The 160-week completion rate was 52.6% and 45.0% for Saxenda and placebo, respectively. Withdrawals due to adverse events were 12.7% with Saxenda and 5.7% with placebo, and the most frequently reported adverse events were gastrointestinal in nature.
Obesity is a disease that requires long-term management. It is associated with many serious health consequences and decreased life-expectancy. Obesity-related comorbidities include type 2 diabetes, heart disease, obstructive sleep apnoea (OSA) and certain types of cancer. It is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors.