GLP-1 labels for adolescents

Approvals by brand

Two separate questions sit behind “can a teenager use this?”: which condition the product is approved for, and from what age. The table answers both from each document’s indication, dosing and paediatric-use sections. Zepbound® and Foundayo™ have no EU product information; in the EU, tirzepatide is sold only as Mounjaro®.

Weight-management trials in adolescents and children

Wegovy® was tested in 201 adolescents who had entered puberty, average age 15, with a BMI at or above the 95th percentile for age and sex. After a 12-week lifestyle run-in with diet and activity counselling, they received semaglutide or placebo once a week for 68 weeks ^[1]. BMI fell by 16.1% on average with Wegovy® and rose by 0.6% with placebo; about 77% on the medicine reduced their BMI by at least 5%, against about 20% on placebo, and one in ten stopped the study drug in each group ^[1].

Saxenda® was studied in 251 adolescents aged 12 to 17, average age 14.5, over 56 weeks after a similar run-in. The trial measured BMI SDS, a score that compares a young person’s BMI with others of the same age and sex; it fell by 0.23 with liraglutide and did not change with placebo, and about 10% on Saxenda® stopped because of an adverse reaction, against none on placebo ^[2]. The published trial adds that during 26 weeks off treatment, BMI SDS rose more in the group that had taken liraglutide ^[15].

In children aged 6 to under 12, the trial behind the European approval randomised 82 children to liraglutide or placebo for 56 weeks with lifestyle counselling. BMI fell by 5.8% with liraglutide and rose by 1.6% with placebo; children reported more stomach effects than adolescents and adults, and about twice as much vomiting as adolescents ^[11]. The US label does not include this age group ^[2].

Type 2 diabetes trials in young people

• Victoza®: 134 young people aged 10 to 17 already on metformin, with or without basal insulin. After 26 weeks HbA1c, a two-to-three-month measure of blood sugar, was about 1.06 points lower than with placebo ^[3]. Blood sugar below 54 mg/dL occurred in 21.2% of those on Victoza®, with no severe episodes ^[3].
• Trulicity®: 154 young people aged 10 and older. After 26 weeks HbA1c fell by 0.8 points with dulaglutide and rose by 0.6 with placebo ^[4]. Injection site reactions were more common than in adults ^[4].
• Mounjaro®: SURPASS-PEDS enrolled 99 young people, average age 15, whose diabetes was not controlled on metformin, basal insulin or both. HbA1c fell by 2.0 points with tirzepatide against 0.2 with placebo after 30 weeks ^[5]. Vomiting, belly pain and low blood sugar were more common than in adults ^[5].

Side effects that differed in young people

• Stomach effects: in the Wegovy® trial, nausea was reported by 42% versus 18% on placebo and vomiting by 36% versus 10% ^[1]. In the Saxenda® trial, nausea was 42.4% versus 14.3% and vomiting 34.4% versus 4% ^[2].
• Gallbladder: gallstones were reported in 3.8% of teens on Wegovy® and none on placebo, more often than in adults on the same medicine ^[1].
• Blood pressure and skin: low blood pressure, rash and hives were more frequent in teens on Wegovy® than in adults; hypotension was reported in 2.3% versus none on placebo ^[1].
• Heart rate: 54% of teens on Wegovy® had a peak rise of 20 beats per minute or more, against 39% on placebo ^[1]. Saxenda® raised resting heart rate by 3 to 7 beats per minute on average, and one treated teenager had pancreatitis ^[2].
• Low blood sugar without diabetes: in the Saxenda® trial, readings below 54 mg/dL occurred in 1.6% versus 0.8%, although none of the teens had diabetes ^[2].

Where the US and Europe differ

The two regions agree on Wegovy® injection from age 12, but the EU adds a body weight above 60 kg and a stopping rule: treatment should be stopped and re-evaluated if an adolescent’s BMI has not fallen by at least 5% after 12 weeks on the maintenance or highest tolerated dose ^[10]. The US label instead lists the 7.2 mg dose among uses not established in children ^[1].

For Saxenda®, the US checkpoint is a BMI reduction of at least 1% after 12 weeks on the maintenance dose ^[2], while the EU asks for at least 4% of BMI or BMI z score, and extends use down to age 6 ^[11]. For Mounjaro®, the EU notes that there are no data in young people weighing under 50 kg and advises caution when increasing to the highest paediatric dose in those under 60 kg ^[12].

What the AAP guideline says about medicines

In 2023 the American Academy of Pediatrics published its first comprehensive obesity guideline in 15 years, a clinical practice guideline for children and adolescents ^[13]. It says clinicians should offer adolescents aged 12 and older with obesity weight-loss medicine, according to each medicine’s indications, risks and benefits, as an adjunct to health behaviour and lifestyle treatment ^[13].

The same guideline describes intensive health behaviour and lifestyle treatment as the most effective known behavioural treatment, with the strongest programmes offering 26 or more hours of face-to-face, family-based care over 3 to 12 months ^[13]. It adds that teens aged 13 and older with severe obesity should be evaluated for metabolic and bariatric surgery ^[13]. A guideline describes options; it does not say a particular teenager should take a particular medicine.

For parents and caregivers

The labels put training first. Mounjaro® asks for patients and caregivers to be trained on the specific presentation they receive, and again if it changes ^[5]. Wegovy® and Victoza® ask clinicians to tell young people about the risk of low blood sugar and teach its signs; for teens with type 2 diabetes, Wegovy® also asks for blood glucose checks before starting and during treatment ^[1][3]. Suspected gallbladder problems call for gallbladder studies and follow-up ^[1].

Saxenda® has a built-in checkpoint for adolescents: if BMI has not fallen by at least 1% after 12 weeks on the maintenance dose, the label says meaningful benefit is unlikely and asks for treatment to stop ^[2]. Whether to start, continue or stop any of these medicines is decided by the young person, their family and a clinician experienced in paediatric care.

PepLabo is designed for people aged 18 and over, as its privacy policy states, so it is not a tool for a teenager’s own treatment records.

Wegovy®, Saxenda®, Victoza®, Ozempic® and Rybelsus® are registered trademarks of Novo Nordisk A/S. Mounjaro®, Zepbound®, Trulicity® and KwikPen® are registered trademarks and Foundayo™ is a trademark of Eli Lilly and Company. PepLabo is not affiliated with or endorsed by Novo Nordisk or Eli Lilly and Company.