Novo Nordisk (NYSE: NVO) said its STEP Young trial met its primary goal, reporting a greater reduction in body-mass index after 68 weeks for once-weekly semaglutide plus lifestyle intervention than for placebo plus lifestyle intervention in children ages 6 to under 12 with obesity.
The company disclosed the topline Phase 3 findings on Monday. Independent verification of the results, including full study data and statistical analyses, was not available.
STEP Young Trial Included Children With Severe Obesity
Novo Nordisk said more than 85% of participants in the STEP Young trial had class II or class III severe obesity when enrolled. Both treatment groups received dietary and physical-activity changes alongside their assigned study treatment.
According to the company, 40.4% of children given semaglutide were no longer categorized as having obesity at week 68, compared with no participants in the placebo group. The announcement did not constitute a regulatory authorization or a treatment recommendation.
