Novo Nordisk's obesity drug shows promise for children aged six to under 12 amid rising off-label use

Novo Nordisk reports that semaglutide, combined with lifestyle support, significantly reduces BMI in young children with severe obesity, highlighting a potential shift in paediatric obesity treatment amid increasing off-label prescriptions and regulatory debates.

Novo Nordisk said on Monday that semaglutide, given alongside diet and exercise support, helped 40.4% of children aged six to under 12 move below the obesity cut-off after 68 weeks, offering one of the clearest signs yet that the class of medicines reshaping adult obesity treatment may also alter care for much younger patients. The result arrives only days after US researchers reported that off-label prescribing of GLP-1 medicines for children aged eight to 11 has surged, even though no drug in the class is approved in the United States for weight loss below the age of 12.

That backdrop matters because use in younger children is already spreading ahead of formal approval. Researchers at NYU Langone, analysing electronic records from more than 300 million Americans across 2,067 hospitals and 47,100 clinics, found that the share of children aged eight to 11 with obesity and no diabetes who were prescribed a GLP-1 rose from 0.03% in 2019 to 9.3% in 2026. Over the study period, 20,282 children in that age group received the drugs. An American Academy of Pediatrics blog discussing the findings noted that overall use across the full period was still only 0.6%, largely because prescribing was minimal before 2022, but said the trend had accelerated after semaglutide was cleared for obesity in older children. The Independent, citing clinicians, reported that doctors may prescribe the medicines off-label and that clinical guidance allows use in some children as young as eight.

Public trial records show that STEP Young is broader than Monday’s topline announcement alone suggests. ClinicalTrials.gov describes it as a study of how semaglutide helps children and teenagers with excess body weight lose weight, using a once-weekly injection combined with healthy-food and physical-activity counselling. On the EU Clinical Trials Information System, the study is listed as a Phase III programme that is still ongoing with recruitment ended, with 210 participants planned across six countries and 18 sites. Novo Nordisk, however, said the children’s analysis involved 165 participants aged six to under 12, highlighting the distinction between the wider programme and the subgroup now being reported. The EU record also shows children had to be at or above the 95th BMI percentile to enter the study.

The company said more than 85% of the children in this part of the trial started out with severe obesity, classified as class II or III, and that all participants received a reduced-calorie diet and increased physical activity regardless of whether they were given semaglutide or placebo. Novo said the children received up to 1.7mg or 2.4mg, depending on starting weight, and that semaglutide beat placebo on the main measure of percentage change in BMI at 68 weeks. The public EU protocol indicates that investigators were not only looking for weight reduction but also for improvement in body-weight category after 68 weeks, as well as changes in cardiovascular risk factors, glucose metabolism and body composition. Detailed data are due to be presented at ObesityWeek in Washington from 14 to 17 November 2026.

Safety is likely to be the next battleground. Novo Nordisk said the overall safety and tolerability profile was consistent with previous semaglutide studies in adults and adolescents, with no new concerns identified, including for growth or pubertal development. But paediatric specialists have been warning that demand is outpacing long-term evidence. Writing for the American Academy of Pediatrics on 4 September, paediatrician Ella Perrin said there was an urgent need for more safety data in younger children and flagged concerns that GLP-1 drugs could worsen disordered eating in vulnerable patients or impair bone mineralisation. Babak Orandi of NYU Langone, lead author of the prescribing study, also said long-term monitoring would be needed. Rachel Pessah-Pollack, an NYU Langone endocrinologist quoted by The Independent, said current prescribing in under-12s is “not a mainstream practice” and is reserved for children “that’s really significantly affected by their weight.”

The prescribing data suggest those children are already among the sickest. NYU Langone said 93.7% of the eight-to-11-year-olds who received GLP-1 prescriptions had severe obesity and 65.2% had at least one related illness, including high cholesterol, high blood pressure or sleep apnoea. A quarter were prediabetic. Orandi described GLP-1 use in this age group as “accelerating rapidly” and argued that careful prescribing could help counter the obesity epidemic. Yet the same study found children from higher-income communities were more likely to receive the drugs, and Allan Massie, a co-senior author, said policymakers and doctors needed to ensure access did not depend simply on insurance cover and the ability to attend specialist clinics.

Regulators have already signalled how much more evidence they want. In a 2025 approval letter for Wegovy tablets, the FDA deferred paediatric weight-management studies for ages six to under 18 and waived the requirement for children under six. The agency said both the FDA and the American Academy of Pediatrics propose that weight-management trials should be limited to children aged seven or older with BMI at or above the 95th percentile, while European Medicines Agency guidance recommends lifestyle treatment alone for children aged two to six and clinical-trial enrolment from ages six to 18. The same FDA letter set a timetable of June 2027 for the final protocol, September 2027 for study completion and January 2028 for the final report for an oral semaglutide study in children aged six to under 12. Monday’s STEP Young result does not settle the debate over treating obesity in primary-school children, but it sharply raises the pressure on regulators, insurers and clinicians to decide how far and how fast these medicines should move into routine paediatric care.