Liraglutide Safely Reduces BMI in Children Ages 6-11 With Obesity in First-Ever Randomized Trial
In the first randomized trial of a GLP-1 receptor agonist in children under 12, liraglutide reduced BMI by 5.8% versus a 1.6% increase with placebo over 56 weeks, with 46% of treated children achieving at least 5% BMI reduction.
Quick Facts
What This Study Found
At week 56, liraglutide 3.0mg daily produced significantly better outcomes than placebo:
- BMI change: -5.8% vs +1.6% (difference: -7.4 percentage points, P<0.001)
- Body weight change: +1.6% vs +10.0% (difference: -8.4 percentage points, P=0.001)
- ≥5% BMI reduction: 46% vs 9% (adjusted OR 6.3, P=0.02)
Note that children in both groups gained weight (they're growing), but liraglutide children gained dramatically less. Adverse events were similar overall (89% vs 88%), but GI events were higher with liraglutide (80% vs 54%). Serious adverse events: 12% liraglutide vs 8% placebo.
Key Numbers
How They Did This
Phase 3a randomized, double-blind, placebo-controlled trial (SCALE Kids). 82 children aged 6 to <12 years with obesity were randomized 2:1 to liraglutide 3.0mg (or maximum tolerated dose) or placebo, both with lifestyle interventions. 56-week treatment period followed by 26-week follow-up. Primary endpoint: percentage change in BMI. (NCT04775082, funded by Novo Nordisk.)
Why This Research Matters
Childhood obesity is a growing epidemic with lifelong health consequences, yet no medications are approved for children under 12. This NEJM trial provides the first randomized evidence that a GLP-1 peptide drug is effective in this young age group, potentially opening the door to earlier pharmacological intervention before metabolic complications become entrenched.
The Bigger Picture
This trial represents the youngest age group in which a GLP-1 receptor agonist has been tested in a randomized controlled trial. As pediatric obesity rates continue to rise globally, the extension of peptide-based therapies to younger children could fundamentally change how childhood obesity is managed. However, the long-term effects of modulating incretin signaling during childhood development remain to be studied.
What This Study Doesn't Tell Us
Small sample size (n=82) limits the ability to detect rare adverse events. Short treatment duration (56 weeks) — long-term safety in growing children is unknown. High rate of GI adverse events (80%) raises tolerability concerns. The study was funded by Novo Nordisk (liraglutide's manufacturer). Children were still growing, making BMI change interpretation complex. The 26-week follow-up period will be important for understanding weight trajectory after stopping treatment.
Questions This Raises
- ?What are the long-term effects of GLP-1 receptor agonist use during critical childhood developmental periods?
- ?Will semaglutide (more effective in adults) produce even better results in children under 12?
- ?Should GLP-1 agonists become first-line therapy for severe childhood obesity, or remain reserved for the most resistant cases?
Trust & Context
- Key Stat:
- -7.4% BMI difference Estimated treatment difference between liraglutide and placebo in BMI change at 56 weeks in children aged 6 to <12 years with obesity (P<0.001)
- Evidence Grade:
- This is a phase 3a randomized, double-blind, placebo-controlled trial published in the New England Journal of Medicine — the gold standard of clinical evidence. Despite the small sample size (n=82), the rigorous design and statistically significant results across primary and confirmatory secondary endpoints provide strong evidence for liraglutide's efficacy in this age group.
- Study Age:
- Published in 2025 in NEJM, this is a landmark study as the first randomized controlled trial of any GLP-1 receptor agonist in children under 12 years of age.
- Original Title:
- Liraglutide for Children 6 to <12 Years of Age with Obesity - A Randomized Trial.
- Published In:
- The New England journal of medicine, 392(6), 555-565 (2025)
- Authors:
- Fox, Claudia K, Barrientos-Pérez, Margarita, Bomberg, Eric M, Dcruz, John, Gies, Inge, Harder-Lauridsen, Nina M, Jalaludin, Muhammad Yazid, Sahu, Kushal, Weimers, Petra, Zueger, Thomas, Arslanian, Silva
- Database ID:
- RPEP-10971
Evidence Hierarchy
Frequently Asked Questions
Is this the first weight loss drug tested in children this young?
Yes — this is the first randomized controlled trial of a GLP-1 receptor agonist in children aged 6 to under 12 years. Currently, no obesity medications are approved for this age group. The positive results could lead to the first approved pharmacological treatment option for childhood obesity in this age range.
Did the children actually lose weight?
Because children are still growing, weight naturally increases. Children on liraglutide gained only 1.6% body weight versus 10% in the placebo group — essentially the drug dramatically slowed weight gain. BMI (which accounts for height growth) decreased by 5.8% with liraglutide versus increasing by 1.6% with placebo. Nearly half (46%) of treated children achieved at least 5% BMI reduction.
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Cite This Study
https://rethinkpeptides.com/research/RPEP-10971APA
Fox, Claudia K; Barrientos-Pérez, Margarita; Bomberg, Eric M; Dcruz, John; Gies, Inge; Harder-Lauridsen, Nina M; Jalaludin, Muhammad Yazid; Sahu, Kushal; Weimers, Petra; Zueger, Thomas; Arslanian, Silva. (2025). Liraglutide for Children 6 to <12 Years of Age with Obesity - A Randomized Trial.. The New England journal of medicine, 392(6), 555-565. https://doi.org/10.1056/NEJMoa2407379
MLA
Fox, Claudia K, et al. "Liraglutide for Children 6 to <12 Years of Age with Obesity - A Randomized Trial.." The New England journal of medicine, 2025. https://doi.org/10.1056/NEJMoa2407379
RethinkPeptides
RethinkPeptides Research Database. "Liraglutide for Children 6 to <12 Years of Age with Obesity ..." RPEP-10971. Retrieved from https://rethinkpeptides.com/research/fox-2025-liraglutide-for-children-6
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Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkPeptides research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.