Saxenda demonstrates significant improvements in cardiometabolic risk factors

Novo Nordisk has presented new data from the three-year part of the Phase IIIa SCALE Obesity and Prediabetes trial at ENDO 2016.

In the three-year part of the trial, data demonstrated that 160 weeks of treatment with Saxenda (liraglutide 3 mg) in combination with a reduced-calorie diet and increased physical activity resulted in significant improvements in cardiometabolic risk factors (such as blood pressure and cholesterol) compared with placebo (reduced-calorie diet and increased physical activity alone).

At week 160, individuals treated with Saxenda had lost more weight (6.1%) than those treated with placebo (1.9%). In addition, treatment with the therapy achieved results beyond weight loss including improvements in some cardiometabolic risk factors such as blood pressure and cholesterol. At week 160, participants randomised to treatment with Saxenda experienced a greater reduction in systolic blood pressure compared with placebo. Those treated with the therapy also experienced greater improvements in triglycerides  and total cholesterol levels. Additionally, people treated with Saxenda showed a greater reduction in mean waist circumference compared with placebo.

Commenting on the results, Dr Ken Fujioka, Scripps Clinic, San Diego, California, US and a SCALE clinical trial investigator, said: “We know that weight loss of as little as 5 to 10% in people with obesity can have an impact on cardiometabolic risk factors. This is currently the longest weight-management trial with Saxenda, and the observed improvements in blood pressure, lipids and waist circumference at three years are encouraging.”

The SCALE Obesity and Prediabetes trial met its primary endpoint

In addition, the three-year part of the SCALE Obesity and Prediabetes trial met its primary endpoint, demonstrating that continued treatment over three years with Saxenda, in combination with a reduced-calorie diet and increased physical activity, delayed the onset of type 2 diabetes compared with placebo.

Aligned with previous trials, during treatment with Saxenda, mean pulse rate was increased. The therapy was generally well tolerated, and observed side effects were in line with previous trials. Over 160 weeks, reports of serious adverse events were higher in those treated with the therapy compared with placebo. Rates of gallbladder-related adverse events and confirmed acute pancreatitis were low, but more frequent in those treated with Saxenda. The frequency of adjudicated major adverse cardiovascular events was low, and comparable in those treated with the therapy and placebo.