Novo Nordisk has reported a phase 3 weight-management win for Wegovy in children, with two out of five kids no longer classified as having obesity after receiving the GLP-1 drug for 68 weeks.
Wegovy, the brand name for semaglutide in indications including obesity, is FDA approved for reducing body weight in people aged 12 years and older. Yet Wegovy and other GLP-1 drugs are increasingly used off-label in younger children, with a recent study finding that prescriptions in kids aged 8 to 11 jumped from 0.03% in 2019 to 9.3% in 2026.
Novo’s Step Young phase 3 trial suggests the younger children may benefit from Wegovy. Participants received weekly Wegovy injections of either 1.7 mg or 2.4 mg, based on their weight at the start of the trial, or placebo. All participants were assigned a reduced-calorie diet and increased physical activity.
At baseline, more than 85% of the children had either class 2 or 3 severe obesity, corresponding to a BMI of at least 35 or 40 in adults, respectively. At Week 68, 40.4% of patients on Wegovy were no longer classified as having obesity, compared to 0% of their peers on placebo. The result reflects the effect if all children adhered to treatment.
“We are encouraged by the positive Step Young results and semaglutide’s potential to help children living with obesity who need medical treatment, alongside lifestyle changes, to better manage their obesity,” Martin Holst Lange, M.D., Ph.D., chief scientific officer at Novo, said in a statement. “This may prevent serious health risks later in life.”
Obesity is increasingly common in younger children, with one study finding that 20.7% of kids aged 6 to 11 in the U.S. have the condition. Weight-related complications emerge earlier and more severely in people who have obesity from a young age.
Novo plans to share detailed results from the trial at ObesityWeek 2026 in November. The topline press release lacks safety and tolerability data, with Novo only saying that the profile was consistent with other trials and free from concerns about growth or pubertal development.
The readout comes as Novo works to get back on track after a bruising period in which it lost ground in obesity to Eli Lilly. The launch of an oral formulation of Wegovy has given Novo renewed momentum this year, with the product making and maintaining a fast launch despite competition from Lilly’s Foundayo.