COPENHAGEN, Sept 7 (Reuters) – Novo Nordisk said on Monday that in a late-stage trial, 40.4% of children aged 6 to under 12 treated with semaglutide, the active ingredient in its blockbuster weight-loss drug Wegovy, were no longer classified as having obesity after 68 weeks, assuming full adherence to the treatment.
All patients enrolled in the trial, called STEP Young, received lifestyle modification throughout the trial, including a reduced-calorie diet and increased physical activity, Novo said in a statement.
“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,” Novo’s Chief Scientific Officer Martin Holst Lange said.
Novo said the trial met its primary endpoint demonstrating superior body mass index reduction at week 68 in the group taking once-weekly subcutaneous semaglutide compared with the placebo group.
The overall safety and tolerability of semaglutide were consistent with those seen in trials with adults and adolescents, it added.
Prescriptions for GLP-1 weight-loss drugs among U.S. children under 12 have risen more than 300-fold since 2019, a study published Friday found, even though the drugs are not approved for that age group.
(Reporting by Louise Rasmussen, editing by Stine Jacobsen)
