Scientific deep-dive

GLP-1 Drugs for Children Under 12: Trial Results, Prescribing Trends and FDA Limits

No GLP-1 drug is FDA-approved for weight loss in children under 12, but a 56-week trial found liraglutide lowered BMI in 6- to 11-year-olds and prescribing is rising. What parents should know about the evidence, side effects, label limits and open questions.

By Eli Marsden · Founding Editor
Editorially reviewed & fact-checked against primary sources · How we verify contentLast reviewed
8 min read·7 citations

Can a child under 12 take Wegovy, Saxenda or another GLP-1 for weight loss? In the US, no GLP-1 is FDA-approved for weight management in children younger than 12. Saxenda and the Wegovy injection are approved from age 12, and Zepbound only for adults.[5][6][7] But the first randomized trial in younger children has now been published. In SCALE Kids, liraglutide lowered BMI by 7.4 percentage points more than placebo in 6- to 11-year-olds with obesity.[1] And prescribing to 8- to 11-year-olds has risen sharply, though it is still uncommon.[2] Here is what parents should know.

About this article

This summarizes peer-reviewed trials, reviews and the current FDA labels on DailyMed. Any use of a GLP-1 drug in a child under 12 would be off-label and should be managed by a pediatrician or pediatric obesity specialist, alongside family-based lifestyle treatment. Online weight-loss services that treat adults are not set up to treat young children. This is not medical advice.

The short answer

  • Not approved under 12. Saxenda (liraglutide) is approved for “pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity,” and the Wegovy injection for “pediatric patients aged 12 years and older with obesity.” For Zepbound, “safety and effectiveness … have not been established in pediatric patients.”[5][6][7]
  • One randomized trial in 6- to 11-year-olds. SCALE Kids (82 children, 56 weeks) found BMI fell 5.8% on liraglutide and rose 1.6% on placebo.[1]
  • Side effects were common. 80% of children on liraglutide had gastrointestinal side effects, against 54% on placebo.[1]
  • Long-term evidence is missing. A 2026 Cochrane review found evidence in children “scant,” with open questions about growth and what happens after stopping.[3]

What the FDA labels say

FDA-approved ages for weight-management GLP-1 drugs (DailyMed, October 2026)
DrugYoungest approved age for weight managementLabel wording
Saxenda (liraglutide)12 years, weight over 60 kg“pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity”
Wegovy injection (semaglutide)12 years“pediatric patients aged 12 years and older with obesity”
Zepbound (tirzepatide)Adults only“safety and effectiveness … have not been established in pediatric patients”

For teenagers, see our guides on GLP-1s for adolescents aged 12–17 and Wegovy for teenagers.

The SCALE Kids trial (NEJM, 2025)

SCALE Kids randomly assigned 82 children aged 6 to under 12 with obesity to daily liraglutide (56) or placebo (26) for 56 weeks, both alongside lifestyle intervention. It was funded by Novo Nordisk, which makes Saxenda.[1]

SCALE Kids results at 56 weeks
OutcomeLiraglutidePlaceboDifference
BMI change−5.8%+1.6%−7.4 percentage points (95% CI −11.6 to −3.2)
Body weight change+1.6%+10.0%−8.4 points (95% CI −13.4 to −3.3)
BMI reduced ≥5%46%9%Adjusted odds ratio 6.3
Gastrointestinal side effects80%54%—
Serious adverse events12%8%—

One result surprises many parents: body weight still went up on liraglutide, by 1.6%, compared with 10.0% on placebo.[1] Because children are still growing taller, the trial's main outcome was BMI, which accounts for height, rather than weight alone. Adverse events of any kind were similar between groups (89% vs 88%), but stomach side effects were more common with the drug.[1]

How often are young children being prescribed GLP-1s?

A 2026 Pediatrics study of more than 3.5 million US children aged 8 to 11 with obesity and no diabetes found that 0.6% had received a GLP-1 prescription. The authors note that “clinical practice guidelines for pediatric obesity management allow for consideration” of GLP-1 drugs in this age group. Prescribing “increased sharply from 2019 to 2026 yet remained uncommon.”[2]

Prescriptions were more likely for 11-year-olds than 8-year-olds, for girls than boys, and for children with obesity-related health problems (188.9 per 10,000). They were also more likely in less socially vulnerable areas, suggesting unequal access. The authors concluded that “clinicians appear to be reserving GLP-1RAs for those at greatest cardiometabolic risk.”[2]

What the reviews say

A 2026 Cochrane review of 37 trials of weight-loss medicines in children and adolescents found that medicines “may reduce” BMI by about 1.8 kg/m² compared with placebo, with low-certainty evidence. But only 8 of the 37 trials enrolled children (most enrolled only teenagers), so “evidence on desirable and undesirable effects in children is scant.” The reviewers flagged uncertainty about “the optimal duration of treatment, consequences of treatment discontinuation, and long-term benefits and harms, particularly considering the physiology of children and impact on growth.”[3]

A 2026 JAMA Pediatrics network meta-analysis of 42 trials in 10- to 19-year-olds found that every medicine worked better when combined with lifestyle treatment, and that health-behavior and lifestyle treatment on its own also produced meaningful BMI reductions.[4] Medication is an addition to lifestyle treatment, not a replacement for it.

Questions to ask your child's doctor

  • Has my child completed, or can they join, a family-based lifestyle program?
  • Does my child have obesity-related conditions, such as high blood pressure, prediabetes or fatty liver, that change the risk-benefit balance?
  • Would this be off-label, and who will monitor growth, side effects and nutrition?
  • What is the plan if treatment stops? In adults, most of the lost weight usually returns after stopping. See what happens when you stop a GLP-1.

Bottom line

No GLP-1 is FDA-approved for weight management in children under 12. One 56-week randomized trial shows liraglutide can lower BMI in 6- to 11-year-olds, at the cost of frequent stomach side effects, and a small but growing number of 8- to 11-year-olds are being prescribed these drugs, mostly those with obesity-related health problems. Long-term effects on growth and development are unknown. Any decision belongs with a pediatric specialist, as part of family-based treatment.

Frequently Asked Questions

Not as an FDA-approved use. Saxenda is approved from age 12 for children weighing more than 60 kg with obesity, and the Wegovy injection from age 12. Zepbound is approved only for adults. Any use in a younger child would be off-label and should be managed by a pediatric specialist.
In the SCALE Kids trial, it lowered BMI by 5.8 percent over 56 weeks, while BMI rose 1.6 percent on placebo, a difference of 7.4 percentage points. Body weight still increased slightly on liraglutide because the children were growing, but by much less than on placebo.
In SCALE Kids, 80 percent of children on liraglutide had gastrointestinal side effects such as nausea or vomiting, compared with 54 percent on placebo. Serious adverse events occurred in 12 percent on liraglutide and 8 percent on placebo. Long-term effects on growth are not known.
Few. A 2026 study of more than 3.5 million US children aged 8 to 11 with obesity found that 0.6 percent had received a GLP-1 prescription, though prescribing rose sharply from 2019 to 2026. Children with obesity-related health conditions were much more likely to be prescribed one.

References

  1. 1.Fox CK, Barrientos-Pérez M, Bomberg EM, Dcruz J, Gies I, Harder-Lauridsen NM, et al. Liraglutide for Children 6 to <12 Years of Age with Obesity - A Randomized Trial N Engl J Med. 2025;392(6):555-565. 2025. PMID: 39258838.
  2. 2.Orandi BJ, Patel SS, Messito MJ, Mankowski MA, Segev DL, Massie AB Trends in GLP-1 Receptor Agonist Prescriptions for Children Ages 8 to 11 With Obesity: 2019-2026 Pediatrics. 2026;158(4):e2026077048. 2026. PMID: 42692477.
  3. 3.Gerardi C, Allocati E, Prutsky G, Carrano FM, Romano E, De Giorgi S, et al. Pharmacological interventions for the treatment of obesity in children and adolescents Cochrane Database Syst Rev. 2026;5(5):CD015986. 2026. PMID: 42125960.
  4. 4.Wan KW, Lei EF, Liu Y, Taddese AA, Ip P, Torbahn G, et al. Obesity Management Pharmacotherapies and Lifestyle Treatment for Pediatric Obesity Management: A Systematic Review and Network Meta-Analysis JAMA Pediatr. 2026;180(9):961-974. 2026. PMID: 42329656.
  5. 5.Novo Nordisk SAXENDA (liraglutide) injection — US Prescribing Information (Section 1) DailyMed, SetID 3946d389-0926-4f77-a708-0acb8153b143. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3946d389-0926-4f77-a708-0acb8153b143
  6. 6.Novo Nordisk WEGOVY (semaglutide) injection and tablets — US Prescribing Information (Sections 1, 8.4) DailyMed, SetID ee06186f-2aa3-4990-a760-757579d8f77b. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b
  7. 7.Eli Lilly and Company ZEPBOUND (tirzepatide) injection — US Prescribing Information (Sections 1, 8.4) DailyMed, SetID 487cd7e7-434c-4925-99fa-aa80b1cc776b. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b

GLP-1 for Teens 12-17: The Pediatric Evidence

Wegovy and Saxenda are FDA-approved for adolescents 12+; tirzepatide is in phase 3 SURMOUNT-ADOLESCENTS. We review the STEP TEENS trial, AAP 2023 obesity guideline, and the practical pediatric prescribing protocol.

12 min read

Saxenda & Victoza (Liraglutide) and Erectile Dysfunction: The Evidence

Obesity and diabetes drive erectile dysfunction through endothelial dysfunction - largely reversible with weight loss. Liraglutide is the older, once-daily GLP-1 with smaller weight loss (~8% in SCALE), so its ED benefit is real but modest, plus a direct positive signal in hypogonadal men.

9 min read

Saxenda & Victoza (Liraglutide) and Sex Drive: The Honest Evidence

No liraglutide trial measures libido. Saxenda and Victoza are the older, once-daily GLP-1 with smaller weight loss (~8% in SCALE) than Ozempic or Zepbound, so any sex-drive effect is weight-loss-mediated and more modest. Men and women, explained.

9 min read

How to Get Saxenda Online (2026): The Daily Liraglutide Pathways & Cost

Saxenda is daily liraglutide 3 mg — the original weight-loss GLP-1. How to get it online in 2026: legitimate telehealth pathways, cost by pathway, Saxenda vs the weekly GLP-1s (Wegovy/Zepbound), and safety.

9 min read

Saxenda (Liraglutide) for Weight Loss: FDA Label, SCALE Trial Evidence, and the New Teva Generic (2026)

Saxenda (liraglutide 3 mg, Novo Nordisk, NDA 206321, DailyMed SetID 3946d389-0926-4f77-a708-0acb8153b143) is the original injectable GLP-1 receptor agonist FDA-approved for chronic weight management — first approved December 23, 2014 and expanded to adolescents 12-17 in December 2020. The pivotal SCALE Obesity and Prediabetes phase 3 trial (Pi-Sunyer NEJM 2015, PMID 26132939; n=3,731, 56 weeks) reported -8.0% mean body-weight change on liraglutide 3 mg vs -2.6% on placebo, with 63.2% of liraglutide patients losing at least 5% of baseline body weight vs 27.1% on placebo. SCALE Diabetes (Davies JAMA 2015, PMID 26284720) replicated -6.0% in T2D patients; SCALE Maintenance (Wadden Int J Obes 2013, PMID 23812094) extended the result to weight maintenance after diet-induced loss. The watershed news: on August 27, 2025, Teva Pharmaceuticals received FDA approval for generic liraglutide 3 mg referencing Saxenda — the FIRST FDA-approved generic GLP-1 receptor agonist for chronic weight management in the United States. Saxenda's effect size (~8% body-weight loss) is meaningfully smaller than Wegovy (~14.9% at 68 weeks per STEP-1, PMID 33567185) and Zepbound (~20.9% at 72 weeks per SURMOUNT-1) in cross-trial indirect comparison, and Saxenda is a once-daily injection vs Wegovy's and Zepbound's once-weekly cadence. Saxenda also carries a class boxed warning for thyroid C-cell tumors, an §8.1 instruction to stop as soon as a pregnancy is recognized, and Aetna's bulletin 1227-C uniquely uses a 4% (NOT 5%) continuation threshold per the Saxenda §2 stop-rule label language.

13 min read

Saxenda Dosage Chart (2026): The Liraglutide Daily Titration Schedule

The full Saxenda (liraglutide) dose ladder, verified against the FDA DailyMed label: 0.6 → 1.2 → 1.8 → 2.4 → 3.0 mg, increasing 0.6 mg weekly, injected once daily. Why it's daily not weekly, missed-dose rules, and Saxenda vs Victoza dosing.

8 min read