New study shows liraglutide reduces BMI in children aged 6-12
A recent trial, published in The New England Journal of Medicine and presented at the European Association for the Study of Diabetes Obesity (EASD), demonstrated that liraglutide effectively lowered body mass index (BMI) in children, but the occurrence of side effects indicates a need for further research.
Currently, no medications are approved to treat non-monogenic, non-syndromic obesity in children under 12. Liraglutide, a glucagon-like peptide-1 (GLP-1) analog, has shown effectiveness in reducing weight in adults and adolescents living with obesity, but its safety and efficacy in younger children had been unknown prior to this trial.
The SCALE Kids trial, a phase 3a randomised controlled study, evaluated liraglutide’s effects and safety in children aged 6 to 12 across 23 sites in nine countries. The study took place between March 2021 and January 2024. Participants had BMIs in the 95th percentile or higher, and none had insulin-dependent diabetes or other obesity-related conditions.
A total of 82 children participated, with 56 receiving liraglutide and 26 receiving a placebo. After 56 weeks, those treated with liraglutide showed a mean BMI reduction of 5.8 per cent, compared to a 1.6 per cent increase in the placebo group. Nearly half of the children on liraglutide experienced a BMI reduction of 5 per cenr or more, while only 9 per cent of the placebo group saw similar results.
Weight changes were also significant, with liraglutide-treated children gaining only 1.6 per cent in weight, compared to a 10 per cent increase in the placebo group. BMI reductions of 10 per cent or more were observed in 35 per cent of liraglutide recipients, compared to just 4 per cent of those given a placebo.
Despite the positive results, 89 per cent of liraglutide-treated children experienced adverse events, primarily gastrointestinal issues, compared to 88 per cent in the placebo group. Serious adverse events occurred in 12 per cent of the liraglutide group and 8 per cent of the placebo group.
The trial showed that liraglutide, combined with lifestyle interventions, can significantly reduce BMI in obese children aged 6 to 12. However, the high rate of side effects, particularly gastrointestinal issues, raises concerns. An ongoing extension of the trial, set to conclude in 2027, will further explore the long-term effects of liraglutide on this age group. Further studies will be necessary to assess the drug’s safety, especially concerning its potential impact on growth and development.