Obesity medication liraglutide proven safe and effective in children under 12, research claims
A ground-breaking study has confirmed that liraglutide, a medication used to treat obesity, is both safe and effective in children aged 6 to under 12 years. The research, presented at the annual meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain (9-13 September), and simultaneously published in the New England Journal of Medicine (NEJM), provides a promising new option for the treatment of paediatric obesity.
The findings demonstrate that children within this age group who were administered liraglutide for just over a year experienced a 7.4% reduction in Body Mass Index (BMI) compared to those given a placebo. Furthermore, these children showed improvements in blood pressure and blood glucose regulation.
The SCALE Kids trial, which is the first clinical study to investigate the safety and efficacy of liraglutide in a paediatric population, offers a glimmer of hope for children living with obesity. According to the researchers, this new development may enable these young individuals to lead healthier, more productive lives.
Professor Claudia Fox, the lead author of the study and an expert in Paediatric Obesity Medicine at the University of Minnesota Medical School in Minneapolis, USA, remarked: “Obesity is the most common chronic disease in childhood. Left untreated, it almost universally persists into adulthood, leading to significant health problems such as diabetes, cardiovascular disease, and in some cases, premature death. Early intervention is therefore critical.”
She continued by highlighting the limited treatment options currently available: “At present, effective treatments are scarce. The primary approach to addressing obesity remains lifestyle therapy, focusing on diet and physical activity changes. However, when used alone, the effects are often modest, and no medication is currently approved for treating general obesity in children younger than 12.”
Liraglutide, already approved as an adjunct to lifestyle therapy in adults and adolescents with obesity, was the focus of this study to assess its safety and efficacy for younger children. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that mimics a naturally occurring hormone. By stimulating the GLP-1 receptor, liraglutide reduces appetite, slows the emptying of the stomach, and promotes feelings of fullness after eating. This medication is administered via daily injections.
The phase 3 study, funded by Novo Nordisk, the pharmaceutical company that manufactures liraglutide, involved 82 children (53.7% of whom were male) aged 6 to under 12 years. At the start of the trial, the average age of the participants was 10 years, their average BMI was 31.0 kg/m², and their average body weight was 70.2 kg (11 stone 1 pound). Over half (54.9%) of the participants were living with at least one obesity-related complication, such as insulin resistance or early onset puberty.
The study divided participants into two groups: 56 children received daily injections of liraglutide (up to 3 mg or the maximum tolerated dose), while 26 children were given weekly placebo injections over a period of 56 weeks. Importantly, all participants received individualised counselling at every visit to encourage adherence to a healthy diet and regular physical activity, with the goal of achieving 60 minutes of moderate to high-intensity exercise each day.
At the conclusion of the treatment period, the average BMI reduction was 5.8% for the liraglutide group, compared to a 1.6% increase in BMI in the placebo group, amounting to a 7.4% difference between the two groups. Similarly, the mean change in body weight was a 1.6% increase for those taking liraglutide and a 10% increase for those on the placebo, revealing an 8.4% difference in body weight change between the two groups.
Furthermore, nearly half (46.2%) of the children receiving liraglutide experienced at least a 5% reduction in BMI, compared to only 8.7% of those in the placebo group. Professor Fox and her team emphasised that since children of this age are continually growing, an increase in body weight over the course of a year would be expected. Therefore, BMI, which accounts for height as well as weight, provides a more informative measure of change.
Professor Fox stated: “Although there is no universally agreed-upon definition of a clinically meaningful reduction in BMI for children, a 5% reduction has been linked with improvements in certain obesity-related health conditions. In our study, we observed that diastolic blood pressure and haemoglobin A1c (HbA1c), which is a measure of blood sugar control, improved more significantly in children who were treated with liraglutide compared to those receiving the placebo.”
Both groups experienced side effects, with 89.3% of the liraglutide group and 88.5% of the placebo group reporting at least one side effect. Gastrointestinal side effects, such as nausea, vomiting, and diarrhoea, were the most common and affected 80.4% of children receiving liraglutide, compared to 53.8% of those receiving the placebo.
Serious side effects were reported by 12.5% of children in the liraglutide group and 7.7% in the placebo group. Four of the seven serious adverse events in the liraglutide group were gastrointestinal in nature. A small proportion (10.7%) of children in the liraglutide group discontinued the treatment due to side effects, whereas no participants in the placebo group withdrew for this reason. The side effects observed align with those previously documented in adolescents and adults using liraglutide.
It was noted that BMI and body weight increased in both groups after the treatment was discontinued, highlighting the need for sustained intervention.
In conclusion, the study found that liraglutide at a 3.0 mg dose resulted in a significantly greater reduction in BMI compared to placebo in children aged 6 to under 12 years living with obesity. The medication was generally well-tolerated, and no new safety concerns were identified.
Professor Fox highlighted the significance of the findings: “The results of this study offer substantial promise for children living with obesity. Up until now, children have had virtually no options to treat obesity and were often simply told to ‘try harder’ with diet and exercise. Now, with the possibility of a medication that targets the underlying physiology of obesity, there is renewed hope that children can lead healthier, more productive lives.”
This study marks a critical step forward in the treatment of paediatric obesity and provides a potential new path for children who previously had limited options.