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Cited by 149Pharmacology and Obesity TreatmentObesity, Physical Activity, DietBariatric Surgery and Outcomes

Liraglutide for Children 6 to <12 Years of Age with Obesity — A Randomized Trial

Fox, Claudia K., Barrientos-Pérez, Margarita, Bomberg, Eric M., Dcruz, John, Gies, Inge, Harder-Lauridsen, Nina M., Jalaludin, Muhammad Yazid, Sahu, Kushal +3 more·2025·New England Journal of Medicine
DOI 10.1056/nejmoa2407379
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Abstract

BACKGROUND: No medications are currently approved for the treatment of nonmonogenic, nonsyndromic obesity in children younger than 12 years of age. Although the use of liraglutide has been shown to induce weight loss in adults and adolescents with obesity, its safety and efficacy have not been established in children. METHODS: In this phase 3a trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we randomly assigned children (6 to <12 years of age) with obesity, in a 2:1 ratio, to receive either once-daily subcutaneous liraglutide at a dose of 3.0 mg (or the maximum tolerated dose) or placebo, plus lifestyle interventions. The primary end point was the percentage change in the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters). The confirmatory secondary end points were the percentage change in body weight and a reduction in BMI of at least 5%. RESULTS: A total of 82 participants underwent randomization; 56 were assigned to the liraglutide group and 26 to the placebo group. At week 56, the mean percentage change from baseline in BMI was -5.8% with liraglutide and 1.6% with placebo, representing an estimated difference of -7.4 percentage points (95% confidence interval [CI], -11.6 to -3.2; P<0.001). The mean percentage change in body weight was 1.6% with liraglutide and 10.0% with placebo, representing an estimated difference of -8.4 percentage points (95% CI, -13.4 to -3.3; P = 0.001), and a reduction in BMI of at least 5% occurred in 46% of participants in the liraglutide group and in 9% of participants in the placebo group (adjusted odds ratio, 6.3 [95% CI, 1.4 to 28.8]; P = 0.02). Adverse events occurred in 89% and 88% of participants in the liraglutide and placebo groups, respectively. Gastrointestinal adverse events were more common in the liraglutide group (80% vs. 54%); serious adverse events were reported in 12% and 8% of participants in the liraglutide and placebo groups, respectively. CONCLUSIONS: Among children (6 to <12 years of age) with obesity, treatment with liraglutide for 56 weeks plus lifestyle interventions resulted in a greater reduction in BMI than placebo plus lifestyle interventions. (Funded by Novo Nordisk; SCALE Kids ClinicalTrials.gov number, NCT04775082.).

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Authors
Fox, C. K., Barrientos-Pérez, M., Bomberg, E. M., Dcruz, J., Gies, I., Harder-Lauridsen, N. M., Jalaludin, M. Y., Sahu, K., Weimers, P., Zueger, T., & Arslanian, S.
Affiliations
  • University of Minnesota (US)
  • Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico
  • Novo Nordisk Global Business Services, Bangalore, India
  • Department of Endocrinology, Diabetes and Metabolic Diseases, Kantonsspital Olten, Olten, Switzerland
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2025-02-06
Volume
392
Issue
6
Pages
555-565
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa2407379
OpenAlex
W4402398738
Cited by
142
References
22
Citations by year
2026: 71 · 2025: 61 · 2024: 10
FWCI
40.34
Type
journal article
Language
en
Open access
closed
Licence
www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • VUBIR (Vrije Universiteit Brussel) (submittedVersion)
Funders
Novo Nordisk A/S
Topics
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Obesity, Physical Activity, Diet
  • Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
Keywords
liraglutide, childhood obesity, GLP-1 receptor agonists, weight loss, body mass index, lifestyle intervention, gastrointestinal adverse effects, drug safety, serious adverse events, drug discontinuation
MeSH terms
Liraglutide, Glucagon-Like Peptide-1 Receptor Agonists, Child, Double-Blind Method, Female, Follow-Up Studies, Gastrointestinal Diseases, Humans, Hypoglycemic Agents, Injections, Subcutaneous, Life Style, Male, Weight Loss, Body Mass Index, Treatment Outcome, Anti-Obesity Agents, Pediatric Obesity

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