Paediatric trials are quietly underway to support prescribing GLP-1 medications for obesity in children younger than 12, despite concerns about their long-term effects on developing bodies. Novo Nordisk, the Danish pharmaceutical manufacturer behind the obesity blockbuster Wegovy, is among the companies expanding this effort, planning to test its weight-loss injections on overweight teenagers in the Pacific region.
The move reflects a significant shift in global health strategy. To date, children have had virtually no options for treating obesity, according to paediatric obesity researchers. But over the past four years, that landscape has changed rapidly. Wegovy has been authorised for paediatric use to treat childhood obesity, and was first approved in 2022 by the U.S. Food and Drug Administration for children aged 12 and older to treat pediatric obesity. Other countries including Germany, the UK, Denmark, and the UAE have since approved it.
The clinical case for the drugs appears strong. In a 68-week randomized controlled trial (STEP TEENS) of 180 participants, those taking Wegovy lost an average of 16.1%, compared to 0.6% in the placebo group. In addition, 44% of those taking Wegovy achieved weight reduction resulting in reclassification to a normal-weight or overweight BMI category versus 12.1% receiving placebo.
However, the evidence base remains incomplete. Side effects were common among those given the drug, particularly gastrointestinal effects such as nausea, vomiting and diarrhea, and experts said doctors and parents would need to carefully consider those risks and the lack of data about the long-term use of such drugs in young kids. Potential long-term risks include a heightened risk of thyroid C-cell tumours, pancreatitis, kidney failure, gallbladder disease, diabetic retinopathy, and weight gain. One obesity specialist noted that the use in kids will stay slow because we are still learning about the long-term effects on growing bodies.
Paediatric uptake globally has been cautious. In the United States, although 14.7 million children have obesity, only 464 children were prescribed Wegovy across five states, including Michigan, Minnesota and Wisconsin since the drug's approval in January 2022. This contrasts sharply with adult adoption, where GLP-1 drugs have achieved blockbuster status.
Despite the caution, expansion appears inevitable. Insiders predict that clinical testing will expand access in the next three to five years as obesity rates soar for children ages 6 to 11. Medical authorities have begun backing the approach. The American Academy of Pediatrics now recommends that pediatricians offer medications or pharmacotherapy to patients 12 years and older with obesity.
The Pacific region focus is significant: The Pacific Islands has the highest rates of obesity in the world, with Nauru and the Cook Islands taking first and second place. It is believed that the recent introduction of Western diets to the islands is the root cause of this, with traditional Pacific Island meals involving fresh fruit and vegetables and locally-sourced meat and fish being replaced by sugar-filled foods, canned goods, soft drinks and alcohol.
Medical opinion remains divided. Some experts see these drugs as essential prevention tools. One pediatric obesity director said, "I use these medications wherever I can. Unlike with adults, where it's more of a rescue operation, we are much more likely with children and adolescents to prevent disease." Others urge caution, noting that the risks for teens could be more severe because of their physiological pubertal development.
For now, Novo Nordisk itself has been circumspect about its paediatric plans. Novo Nordisk declined to comment on clinical trials involving children younger than 12. The company emphasises that treatment decisions should involve multiple stakeholders: "For youths considering GLP-1s, the decision should be at the discretion of the physician, the adolescent patient and their caregiver."