Liraglutide is safe and effective in children aged 6 to <12 years and those who took liraglutide for just over a year experienced a reduction in BMI of 7.4% vs. placebo and experienced improvements in blood pressure and blood sugar control, according to research presented at the annual meeting of the European Association for the Study of Diabetes and published simultaneously in the New England Journal of Medicine.
"Obesity is the most common chronic disease of childhood. Left untreated, obesity in childhood almost universally persists into adulthood and is associated with significant ill health, including diabetes and cardiovascular disease, and for some, premature death. Early intervention is therefore critical,” explained lead author, Professor Claudia Fox, of the Center for Pediatric Obesity Medicine, University of Minnesota Medical School. "However, effective treatment options to date are limited. The backbone of obesity treatment is lifestyle therapy - changes in diet and physical activity - but when used alone, the effect is modest and, as yet, no medication is approved for the treatment of general obesity in children who are younger than 12. Liraglutide is approved as an adjunct to lifestyle therapy in adults and adolescents with obesity and, in this study, we explored its safety and efficacy in under-12s."
These results from the SCALE Kids trial - the first study to examine the safety and efficacy of liraglutide in the paediatric population - offer hope that children who are living with obesity can lead healthier, more productive lives, the researcher noted presenting and writing on behalf of the for the SCALE Kids Trial Group.
Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. It mimics action of a hormone called GLP-1 to reduce appetite and feelings of hunger, slow the release of food from the stomach and increase feelings of fullness after eating and is given daily, as an injection.
The phase 3 study, which was funded by liraglutide maker Novo Nordisk, involved 82 children (53.7% male) aged 6 to <12 years. At baseline, average age was 10 years, BMI was 31.0 kg/m2 and body weight was 70.2 kg (11st 1lb). 54.9% of children had ≥1 obesity-related complication, such as insulin resistance or early puberty.
I total, 56 children received daily injections of liraglutide (3mg or maximum tolerated dose) and 26 received weekly injections of placebo for 56 weeks. All of the participants received individualised counselling at every visit to encourage adherence to a healthy diet and regular physical activity (with the aim of doing 60 minutes a day of moderate to high intensity exercise).
At the end of the treatment period, the mean change in BMI was −5.8% for liraglutide and +1.6% for placebo, a difference of 7.4%. Mean change in body weight was +1.6% for liraglutide and +10% for placebo, a difference of 8.4%. A reduction in BMI of at least 5% was observed in 46.2% of children receiving liraglutide and 8.7% receiving placebo.
Children of this age are constantly growing and so body weight would be expected to increase over the course of a year. BMI takes into account height, as well as weight, and so is more informative, say the researchers.
"Although there is no consensus on the definition of a clinically meaningful BMI reduction in children, a 5% reduction has previously been shown to be associated with improvement in some obesity-related health conditions,” she added. “In our study, diastolic blood pressure and haemoglobin A1c [HbA1c], a measure of blood sugar control, improved more in children receiving liraglutide than in those receiving the placebo."
Side-effects were common in both groups (89.3% of liraglutide recipients and 88.5% of placebo recipients). Gastrointestinal side effects (e.g., nausea, vomiting, diarrhoea) were the most common and occurred in 80.4% of children receiving liraglutide and 53.8% receiving placebo.
12.5% of the liraglutide recipients and 7.7% of the placebo recipients experienced serious side-effects. Four of the 7 serious adverse events in the liraglutide group were gastrointestinal in nature and 10.7% of those in the liraglutide group discontinued treatment due to side-effects, versus none in the placebo group. This is in line with what has previously been observed in adolescents and adults taking liraglutide. BMI and body weight increased in both groups after treatment stopped.
The researchers conclude that liraglutide 3.0mg led to a greater reduction in BMI than placebo in children aged 6 to younger than 12 years living with obesity. Liraglutide was well-tolerated and there were no new safety concerns.
"The results of this study offer considerable promise to children living with obesity. To date, children have had virtually no options for treating obesity. They have been told to 'try harder' with diet and exercise,” Fox concluded. "Now with the possibility of a medication that addresses the underlying physiology of obesity, there is hope that children living with obesity can live healthier, more productive lives."
The findings were reported in the paper, 'Liraglutide for Children 6 to <12 Years of Age with Obesity — A Randomized Trial, published in the New England Journal of Medicine. To access this paper, please click here
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