Novo Nordisk STEP Young Phase 3: 40.4% of Children Aged 6 to Under 12 No Longer Classified as Obese at Week 68 With Semaglutide Plus Lifestyle Modification Versus 0% Placebo
Novo Nordisk (NYSE: NVO) announced Monday September 7, 2026 first results from STEP Young, a Phase 3 randomized double-blind placebo-controlled multinational trial evaluating once-weekly semaglutide combined with a reduced-calorie diet and increased physical activity in children aged 6 to under 12 years with obesity. The trial enrolled 165 children, dosed with a maximum of 1.7 mg or 2.4 mg semaglutide based on baseline weight. At week 68, 40.4% of the semaglutide group had a BMI below the obesity threshold versus 0% in the placebo group; more than 85% of enrolled children had class II or III severe obesity (BMI ≥35 or ≥40 by adult equivalents) at baseline. Safety and tolerability were consistent with adult and adolescent trials with no new safety concerns and no signals related to growth or pubertal development. Detailed results will be presented at ObesityWeek 2026 in Washington DC November 14-17. Wegovy is currently approved in the U.S. for adolescents 12 and older; a supplemental submission for children under 12 has not been announced.