Novo Nordisk reports positive outcomes in a late-stage trial of semaglutide for children aged six to under 12, amid rising off-label prescriptions and ongoing debate over obesity treatment in young children.
Novo Nordisk said on Monday that semaglutide had met the main goal in a late-stage trial in children aged six to under 12, a development likely to sharpen a debate already moving ahead of regulators in the United States. Just three days earlier, researchers at NYU Langone reported in Pediatrics that prescriptions for GLP-1 obesity drugs in eight- to 11-year-olds had risen steeply since 2019, even though none of the medicines studied carries US approval for weight management below the age of 12.
The new prescribing analysis drew on electronic health records for more than 3.5 million US children with obesity but not diabetes. It found that 20,282 children aged eight to 11 were given a GLP-1 medicine between January 2019 and June 17, 2026. Annual prescribing in that group rose from 0.03 per cent in 2019 to 9.3 per cent in 2026, which the researchers described as a 310-fold increase. Reuters, which reported the findings on September 4, said the jump reflected doctors looking for newer and more effective options for younger patients with obesity, even as overall use in this age band remained lower than among adolescents.
The children who did receive the medicines were, in most cases, among the sickest in the dataset. NYU said 93.7 per cent had severe obesity, while 65.2 per cent had at least one related illness, including high blood pressure, high cholesterol or sleep apnoea. Becker’s Hospital Review noted that one in four had prediabetes. Girls were prescribed the drugs more often than boys, and older children in the eight-to-11 bracket were more likely to receive them than the youngest patients.
That matters because the prescribing is happening in a grey zone between clinical need and formal approval. Saxenda and Wegovy are cleared by the US Food and Drug Administration for obesity in patients aged 12 and over, while Zepbound is approved only for adults. Yet paediatric obesity guidance has allowed clinicians to consider drug treatment from age eight, alongside diet, physical activity and behavioural support. In the NYU release, lead investigator Babak Orandi said the research offered “the first national overview in young children” of how those medicines are being used, adding that the numbers were still low but rising fast.
The study does not answer the questions parents and clinicians are most likely to ask next. Patient Care Online pointed out that the paper tracked prescribing, not outcomes, and did not report changes in BMI, cardiometabolic measures, gastrointestinal side effects, growth, pubertal development or whether children stayed on treatment. The same outlet also noted a point that may need fuller explanation in the published paper: the 9.3 per cent figure for 2026 sits awkwardly beside the far smaller 0.6 per cent share reported across the whole study period, suggesting different denominators or time windows are in play.
Access, rather than medical enthusiasm alone, also seems to be shaping who gets the drugs. Children in higher-income communities were 55 per cent more likely to receive a GLP-1 prescription than other children with obesity, according to NYU and CBS New York, despite obesity rates tending to be higher in poorer areas. Allan Massie, a co-senior author, said in the NYU announcement: “Physicians and health policymakers alike have a responsibility to ensure, as use of GLP-1 medications continues to rise, that all young children with obesity who need these drugs have access to them and that these valuable and sometimes costly treatments become available to more than those who have access to health insurance and can afford to visit pediatric clinics.”
Orandi himself struck a notably cautious tone in his CBS interview. “I think it’s important to have a healthy degree of skepticism,” he said, recalling advice from a medical school lecturer: “You never want to be the first person to take a new medication, and you never want to be the first doctor to prescribe a new medication.” At the same time, he argued that the danger of leaving severe childhood obesity untreated was already clear. Medical Xpress, echoing the NYU account, said he warned of later diabetes, hypertension and liver disease if effective treatment is delayed. He also stressed that GLP-1 drugs are not a stand-alone answer and should be used with lifestyle changes rather than instead of them.
Monday’s Novo Nordisk announcement may now shift the argument again. The company said 40.4 per cent of children in its STEP Young trial were no longer classified as having obesity after 68 weeks on semaglutide plus lifestyle support, compared with none in the placebo group. Novo said the trial enrolled 165 children aged six to under 12, most of whom had class II or III severe obesity at the start, and that no new safety concerns were identified, including for growth or pubertal development. Detailed results are due to be presented at ObesityWeek in Washington in November. Until then, the picture in US paediatric obesity care is becoming clearer but not simpler: doctors are already prescribing these drugs to some younger children, evidence for that practice is only beginning to emerge, and who can get treatment appears to depend heavily on where they live and what they can afford.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
