Novo Nordisk releases Phase 3 trial results for obese children

Severely obese young patients improved to normal or overweight range

An image related to childhood obesity. [Getty Images Bank]
An image related to childhood obesity. [Getty Images Bank]

Forty percent of children aged 6 to 12 who received Wegovy (semaglutide) improved to a normal or overweight body weight range, according to new clinical trial results.

The findings have drawn attention to whether Wegovy's approved age range — currently 12 and older — could be expanded to younger children.

Danish pharmaceutical company Novo Nordisk recently released key results from its Phase 3 trial (STEP Young), which enrolled patients aged 6 to under 12.

According to Fierce Pharma and other pharmaceutical trade outlets, 165 children with obesity from multiple countries participated in the trial. Of those, 85 percent had severe obesity classified as Grade 2 or Grade 3 by body mass index.

Researchers compared children who received Wegovy — at doses of 1.7 mg or 2.4 mg depending on body weight — against a placebo group. Both groups followed a calorie-restricted diet and a structured exercise regimen as part of a lifestyle modification program.

After 68 weeks, 40.4 percent of children in the Wegovy group had dropped below the obesity threshold, improving to a normal or overweight classification. Not a single child in the placebo group — who received only lifestyle intervention — moved out of the obese range.

However, the 40.4 percent figure is based on an analysis that assumes full adherence to treatment. Researchers noted that real-world results could vary depending on how consistently patients follow the regimen.

Some patients experienced side effects including nausea, vomiting and diarrhea. Novo Nordisk said these were broadly consistent with the drug's previously reported tolerability and side-effect profile.

The trial found no notable impact on physical growth — including skeletal development — or pubertal development, two of the most closely watched concerns when administering the drug to young children.

In practice, Wegovy is already being prescribed to young children in the United States through off-label use. Research has shown that the rate of Wegovy prescriptions for children aged 8 to 11 in the US jumped from 0.03 percent in 2019 to 9.3 percent in 2026.

Meanwhile, detailed data from the Phase 3 trial are expected to be presented at ObesityWeek 2026, the annual conference of the Obesity Society, to be held in Washington, D.C., from Nov. 14 to 17.


jshan@heraldcorp.com