Novo Nordisk has reported a significant phase 3 trial result for Wegovy in younger children, with two in five participants no longer classified as having obesity after 68 weeks of treatment.
The STEP Young trial tested weekly injections of semaglutide, marketed as Wegovy, in children who had not previously been covered by the drug’s existing FDA approval.
Wegovy currently holds FDA approval for reducing body weight in people aged 12 years and older, but use in younger children has been growing rapidly through off-label prescribing.
A recent study found that Wegovy prescriptions in children aged 8 to 11 jumped from just 0.03% in 2019 to 9.3% in 2026, reflecting the surge in demand among younger patient groups.
Participants in the STEP Young trial received weekly Wegovy injections of either 1.7 mg or 2.4 mg based on their starting weight, or a placebo, alongside a reduced-calorie diet and increased physical activity.
At baseline, more than 85% of the children enrolled had either class 2 or class 3 severe obesity, corresponding to a BMI of at least 35 or 40 in adults respectively.
By week 68, 40.4% of patients on Wegovy were no longer classified as having obesity, compared to 0% of those on placebo, based on results reflecting full treatment adherence.
Patients also tolerated the drug well, with no new safety concerns identified around growth, pubertal development, or general adverse events during the course of the trial.
Novo Nordisk plans to present full details from the STEP Young study at ObesityWeek 2026, scheduled for 14 to 17 November in Washington DC, where the broader scientific community will be able to scrutinise the complete dataset.
The positive readout arrives at a strategically important moment for Novo, which has been working to recover momentum after losing ground in the obesity market to rival Eli Lilly.
The launch of an oral formulation of Wegovy has helped Novo Nordisk regain footing in 2026, maintaining a strong commercial trajectory despite competition from Lilly’s Foundayo.
A successful label expansion into younger children could open a meaningful new patient population for Wegovy and further strengthen Novo’s position in the increasingly competitive GLP-1 drug market.