Saxenda (liraglutide) could benefit patients with prediabetes and obesity to help them achieve weight loss and improve cardiometabolic risk factors, data from the Phase 3 SCALE (Satiety and Clinical Adiposity – Liraglutide Evidence) Obesity and Prediabetes trial has revealed.
The evidence, presented at the first European Obesity Summit (EOS 2016), looked at adults with prediabetes and obesity or who were overweight with comorbidities. These were randomised to receive liraglutide (n=1,505) or placebo (n=749) for 160 weeks, both as an adjunct to a reduced-calorie diet and increased physical activity.
The study found that people treated with liraglutide who lost 5% or more of their body weight at 16 weeks (classified as ‘early responders’) demonstrated greater weight loss and improvements in cardiometabolic risk factors at week 160 compared with those who lost less than 5% of their body weight at 16 weeks (‘early non-responders’).
At week 16, 68% of people treated with liraglutide were early responders versus 22.3% of people treated with placebo. At week 160, liraglutide early responders who completed the trial (n=580) achieved an average weight loss of 8.6% (9.1 kg), compared with 2.9% (3.1 kg) in early non-responders (n=210). In addition, liraglutide early responders experienced improvements across a range of glycaemic measures including regression to normoglycaemia (69.8 vs 55.4%) and reduced development of type 2 diabetes (0.5 vs 3.2%) compared with early non-responders.
Additionally, liraglutide early responders who completed 160 weeks of treatment also experienced greater improvements in systolic blood pressure (-3.7 vs -3.3 mmHg), and improvements in health-related quality of life measures (IWQoL-Lite score 13.4 vs 9.5) compared with early non-responders.
Professor Sten Madsbad, Clinical Professor at the University of Copenhagen and SCALE clinical trial investigator, said: “These findings demonstrate the predictive nature of an early response to treatment, which is important information that clinicians can use to identify those who are most likely to experience long-term benefits with Saxenda.
“It is also encouraging that we continue to see benefits in addition to weight loss experienced with Saxenda, including improvements in cardiometabolic risk factors and glycaemic status for people completing the trial.”
Liraglutide was generally well-tolerated, and observed side effects were in line with previous trials. Rates of adverse events were similar between early responders and early non-responders (97.1 vs 95%). The most common side effects reported by early responders and early non-responders were related to the gastrointestinal system (75.3 vs 71.6%). Gallbladder disorders were more frequent in early responders compared with early non-responders (6.3 vs 2.2%).