Mixed opinions on GLP-1s for 6 year olds
Key Takeaways
A recent RCT showed that liraglutide plus lifestyle interventions resulted in greater BMI reduction when compared to placebo plus lifestyle interventions in children aged 6 to <12 years with obesity.
Long-term safety and effects on growth and development of using GLP-1 agonists in young children remain unknown, necessitating careful consideration before prescribing.
The study's limitations, which included lack of body composition measurement, limited diversity in participants, and uncertainty about the treatment duration, highlight the need for further research and cautious application of these findings in clinical practice.
We know that GLP-1 prescriptions are trending across all patient groups, but will we soon be recommending these weight-loss drugs for children?
A new study of the GLP-1 drug liraglutide is currently making headlines for its use in children as young as 6 years of age.[] While obesity in young people can clearly lead to long-term health risks, some physicians are expressing concern about the risks of rapid weight loss in still-developing bodies.
Let’s take a closer look at the study and investigate the risks vs benefits on this vulnerable population.
What the study revealed
Currently, the use of liraglutide for the long-term treatment of obesity is FDA-approved in adults. However, in a September 2024 issue of the New England Journal of Medicine, researchers reported the results of a randomized controlled trial of liraglutide (funded by Novo Nordisk) for the treatment of nonmonogenic, nonsyndromic obesity in children who were younger than that.[]
The 82 pediatric patients who participated in the 56-week trial ranged in age from 6 to <12 years.
In summarizing the trial results, the study authors wrote that, among these children, “treatment with liraglutide for 56 weeks plus lifestyle interventions resulted in a greater reduction in BMI than placebo plus lifestyle interventions.”[]
Serious adverse events were reported in 12% of the participants in the liraglutide group, as compared with 8% of those in the placebo group. Additionally, gastrointestinal adverse events were significantly more common in the liraglutide treatment arm (80% vs 54%).
Discussing the controversies
While this trial has shown efficacy to reduce BMI (reminder—this is not necessarily the same as fat mass) in young children, the long-term safety of using GLP-1s or any other weight-loss medication in children as young as 6 to 11 years of age is unknown, because the long-term effects on growth and development are still unknown.
In a discussion in Nature of the issues surrounding use of GLP-1s in children, the author points out that “GLP-1 mimics are currently considered lifelong drugs.”[] But this raises some important questions for children, as Sarah Ro, MD, a weight management specialist who was interviewed for the article, considers. In practice, she says, “some children will need to stop taking the drugs—when their families lose insurance coverage, for example, or if the negative side effects, such as nausea, become intolerable."
"What the exit strategy would look like for kids is a key question for further research."
— Sarah Ro, MD, Nature
Many pediatricians and public health experts would much prefer to see childhood obesity prevented through education and systematic societal changes, and treated via lifestyle interventions, which are safe, effective, and long-lasting.
The Nature article also relates the reservations that some physicians have regarding the use of obesity drugs in general, “and especially for children and adolescents, whose bodies are still developing.”[]
Sarah Nutter, PhD, a weight stigma researcher at the University of Victoria in Canada who was also interviewed for the article, expressed her concerns that “families might make decisions on the basis of weight stigma.” All agree that further research is needed on the safety and efficacy of obesity medications in children, particularly as compared with lifestyle interventions, over the long term.
Trial limitations
It should be noted that body composition was not measured in this RCT, so the possibility of a loss of muscle mass cannot be ruled out, especially because BMI is known to be a poor surrogate for fat mass. In addition, the number of children included from traditionally underserved populations was small (for instance, only 6 of the 82 participants were Black), so extrapolating the results to these populations is problematic.
Another issue of concern raised by this trial is the issue of therapeutic duration. As noted by the authors of an accompanying editorial, “During the off-treatment follow-up period, the BMI standard-deviation score increased in the liraglutide group, which is worrisome because it implies the ongoing need for pharmacotherapy to prevent BMI rebound.”[]
What this means for you
As a physician, you may encounter increasing interest from parents in using GLP-1 agonists for weight management in young children with obesity. While the recent study shows promise for liraglutide's efficacy in reducing BMI in children aged 6 to 11, it's crucial to approach this option with caution due to limited long-term safety data and potential side effects. When discussing treatment options with families, it is a good idea to mention that all major medical societies still recommend lifestyle interventions as the first-line approach.