The phase IIIa SCALE Kids trial conducted by Claudia Fox, MD, of the University of Minnesota Medical School, explored the impact of liraglutide (Saxenda) on young children with obesity. It was found that when liraglutide was added to lifestyle intervention, there was a significant reduction in BMI among children aged 6 to less than 12 years. This demonstrates the potential of liraglutide as an effective treatment for childhood obesity.
“The backbone of treatment — lifestyle therapy — is often insufficient in achieving clinically significant and durable BMI reduction,” stated Claudia Fox. This highlights the need for alternative therapies to address obesity in children, especially those who have not responded effectively to lifestyle changes alone. The findings of the SCALE Kids trial offer a promising solution for such cases.
The results of the trial showed that children who received liraglutide experienced a 5.8% reduction in BMI compared to a 1.6% gain in those who received lifestyle intervention alone. This significant difference underscores the potential of liraglutide as a therapeutic option for young children with severe obesity. Additionally, nearly half of the liraglutide group lost at least 5% of BMI, further supporting the efficacy of this treatment approach.
SCALE Kids trial enrolled children with a BMI in the 95th percentile or higher, emphasizing the severity of obesity in the study population. The trial also compared favorably to the previous SCALE Teens trial, with a BMI standard-deviation score treatment difference that nearly doubled the difference reported in adolescents. This suggests that liraglutide may be even more effective in younger children with obesity.
While liraglutide showed promising results in reducing BMI and improving metabolic variables, there were some gastrointestinal adverse events reported in the liraglutide group. Nausea, vomiting, and diarrhea were the most common adverse events, with a small percentage of participants discontinuing treatment due to these effects. It is crucial to continue monitoring the long-term effects of liraglutide in children to ensure its safety and efficacy.
To address the lingering questions regarding the effects of liraglutide on growth and puberty in children, a 3-year, open-label extension phase of the trial is currently ongoing. This extension phase aims to provide further insights into the long-term effects of liraglutide treatment in young children with obesity. By continuing to monitor participants and assess their response to treatment over an extended period, researchers can gain a better understanding of the benefits and potential risks associated with liraglutide.
The SCALE Kids trial demonstrates the potential of liraglutide as an effective treatment option for young children with obesity. By combining liraglutide with lifestyle intervention, significant reductions in BMI and improvements in metabolic variables were observed. While there were some gastrointestinal adverse events reported, the overall benefits of liraglutide treatment outweighed the risks. Continued research and monitoring are essential to further evaluate the long-term effects of liraglutide in children and ensure its safety and efficacy as a treatment for childhood obesity.
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