Weight-Loss Drug Shows Promise in Young Children, Trial Results Indicate

Novo Nordisk has announced preliminary results from a Phase 3 clinical trial suggesting that semaglutide, the active ingredient in weight-loss medications Wegovy and Ozempic, may be effective in treating obesity in children as young as six years old. The trial, named STEP Young, involved 165 children aged 6 to 12 who were randomly assigned to receive either semaglutide or a placebo, alongside lifestyle interventions including diet and exercise. After 68 weeks, approximately 40% of the children treated with semaglutide were no longer classified as obese, compared to none in the placebo group. The study met its primary goal, showing a significantly greater reduction in BMI for the semaglutide group.

While the initial findings are encouraging, the company noted that the 40% figure assumes full adherence to the treatment, which may not always be the case. The trial reported that the safety profile and tolerability of semaglutide in this age group were consistent with previous studies on adults and adolescents, with no new safety concerns identified, including impacts on growth and sexual development. The study was double-blind and placebo-controlled, considered a high standard for drug efficacy testing.

In Israel, Wegovy is currently covered by the national health basket for adolescents meeting specific criteria but is not approved for children under 12. The announcement from Novo Nordisk highlights a broader trend of expanding the use of GLP-1 receptor agonist drugs to younger age groups, even before official approval. A separate U.S. study published in Pediatrics revealed a dramatic increase in prescriptions for these drugs among children aged 8 to 11, rising 310-fold since 2019, though the overall percentage remains low.

This U.S. study, analyzing data from over 3.5 million obese children aged 8 to 11 without diabetes, found that while these medications are not approved for those under 12, some clinical guidelines permit their use for children as young as eight in specific circumstances. The research indicated that 94% of children prescribed GLP-1 drugs were severely obese, and about 65% had at least one comorbidity like high cholesterol, high blood pressure, or sleep apnea. Researchers emphasized the need for long-term safety monitoring due to the accelerating use of these medications in younger populations.