Novo Nordisk Reports Positive Semaglutide Trial Data for Obesity in Children Aged 6-11

Novo Nordisk (NVO) on Monday announced positive results from a late-stage trial showing that semaglutide, the active ingredient in its blockbuster weight-loss drug Wegovy, significantly reduced obesity in children aged 6 to under 12.

Key Trial Findings

According to a company statement, the Phase 3 trial, named STEP Young, met its primary endpoint by demonstrating a superior body mass index (BMI) reduction in the group taking semaglutide compared to the placebo group after 68 weeks.

Key results from the trial include:

• 40.4% of children treated with once-weekly subcutaneous semaglutide were no longer classified as having obesity after the 68-week period, assuming full treatment adherence.
• All participants in the study, including those on placebo, received lifestyle modification support, such as a reduced-calorie diet and increased physical activity.
• The overall safety and tolerability profile of semaglutide was consistent with previous trials conducted in adults and adolescents, the company added.

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"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," said Martin Holst Lange, Novo’s Chief Scientific Officer.

Market Implications

These results could pave the way for a significant expansion of the addressable market for Novo Nordisk's highly profitable GLP-1 franchise. An approval for this younger age group would open a new patient population for Wegovy, which is currently approved for adolescents aged 12 and older.

The data comes amid evidence of substantial off-label use of these medications in younger patients. A study published last week found that prescriptions for GLP-1 weight-loss drugs for U.S. children under 12 have increased more than 300-fold since 2019, highlighting existing demand that Novo Nordisk could capture with a formal regulatory approval.