Liraglutide, also known as Saxenda, has been found to be effective in reducing BMI in young children with obesity according to the phase IIIa SCALE Kids trial. The study, which included children aged 6 to Findings of the SCALE Kids Trial
At week 56, children in the liraglutide group lost 5.8% of their BMI, while those in the placebo group experienced a 1.6% gain. This difference was reported to be -7.4%, indicating the effectiveness of liraglutide in reducing BMI in this age group. Nearly half of the children in the liraglutide group lost at least 5% of their BMI, compared to only 9% in the placebo group.
Evidence for the Effects of Liraglutide
The results of the trial have provided valuable evidence for the effects of a GLP-1 receptor agonist in young children with obesity. This offers a new therapeutic option for prepubertal children with severe obesity in addition to healthy lifestyle interventions. The study also highlighted the potential benefits of liraglutide in improving metabolic variables such as insulin sensitivity and hepatic steatosis.
Comparison with the SCALE Teens Trial
The reduction in the BMI standard-deviation score observed in the SCALE Kids trial was nearly double that of the SCALE Teens trial conducted in adolescents aged 12 to 17. This suggests that liraglutide may have a greater impact on younger children with obesity. The FDA approval of liraglutide for chronic weight management in adolescents in 2020 further supports its efficacy in this age group.
The SCALE Kids trial enrolled children with a BMI in the 95th percentile or higher, with an average age of 10 years. The majority of participants had class 2 or class 3 obesity, indicating the severity of their condition. While none of the children had type 2 diabetes, 20% exhibited signs of insulin resistance. The trial was carried out over a 56-week treatment period followed by a 26-week off-treatment period.
Side Effects and Adverse Events
As with any medication, liraglutide was associated with some side effects and adverse events in the study. Gastrointestinal issues were more common in the liraglutide group, with nausea, vomiting, and diarrhea being the most frequently reported symptoms. However, no significant effects on growth and puberty were observed during the trial period.
The SCALE Kids trial has provided important insights into the use of liraglutide for the treatment of obesity in young children. The ongoing 3-year, open-label extension phase of the trial aims to further investigate the long-term effects of liraglutide on growth, puberty, and other metabolic outcomes. This research will be crucial in determining the safety and efficacy of liraglutide as a treatment option for pediatric obesity.
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