Bagsværd, Denmark — September 7, 2026
Novo Nordisk announced positive first results from the STEP Young Phase 3 trial, strengthening the company’s pediatric obesity development program for children aged 6 to under 12 years. The multinational randomized, double-blind, placebo-controlled study evaluated once-weekly subcutaneous semaglutide combined with lifestyle modification, including a reduced-calorie diet and increased physical activity. The trial met its primary endpoint, demonstrating a greater reduction in body mass index (BMI) at week 68 among children receiving semaglutide compared with placebo. A key finding was that 40.4% of children treated with semaglutide were no longer classified as having obesity at week 68, compared with 0% in the placebo group. More than 85% of participants entered the study with class II or class III severe obesity, highlighting the population targeted by the development program. The results add an important pediatric clinical-development milestone for Novo Nordisk as the company continues expanding its obesity medicine portfolio into younger patient populations.
STEP Young Trial Evaluates Semaglutide With Lifestyle Modification
The STEP Young Phase 3 trial enrolled 165 children with obesity aged 6 to under 12 years, evaluating semaglutide against placebo over the study period. Both treatment groups received lifestyle modification throughout the trial, ensuring that the investigational treatment was evaluated alongside reduced-calorie dietary intervention and increased physical activity. The primary endpoint assessed the percentage change in BMI from baseline to week 68, while a confirmatory secondary endpoint evaluated improvement in BMI classification. The study also included supportive assessments covering anthropometric measurements, cardiovascular risk factors, glucose metabolism and body composition. Children received a maximum semaglutide dose of either 1.7 mg or 2.4 mg, based on their weight at the start of the study. The findings provide additional clinical evidence for semaglutide in pediatric obesity and expand the clinical-development dataset supporting the use of the GLP-1 receptor agonist across different age groups. Detailed results from STEP Young are scheduled for presentation at ObesityWeek 2026 in Washington, D.C., in November.
Safety Profile Remains Consistent With Previous Semaglutide Trials
Alongside the efficacy findings, Novo Nordisk reported that the overall safety and tolerability of semaglutide in STEP Young were consistent with previous pediatric and adult clinical trials involving semaglutide and liraglutide. The company reported no new safety concerns from the study. Importantly for the pediatric population, Novo Nordisk said that no safety concerns were identified regarding growth or pubertal development. These observations are relevant to the continued development of pharmacological approaches for childhood obesity, where long-term treatment considerations extend beyond weight-related outcomes. The company highlighted the potential significance of medical treatment for children whose obesity is not adequately managed through lifestyle modification alone. The trial data therefore add both efficacy and safety information to Novo Nordisk’s pediatric obesity program while the company prepares to present the complete dataset. The detailed analysis is expected to provide additional information on the trial’s secondary and supportive endpoints, including changes in metabolic and body-composition measures.
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Novo Nordisk Advances Pediatric Obesity Medicine Program
The STEP Young results represent another development milestone for Novo Nordisk’s semaglutide franchise, which includes medicines used across cardiometabolic indications. Semaglutide is a GLP-1 receptor agonist that acts on pathways involved in glucose regulation and body weight. The company is continuing to evaluate the medicine across multiple clinical settings while expanding its presence in obesity treatment. In pediatric obesity, the latest Phase 3 findings could support further regulatory and development activity, although the announcement itself does not constitute a new regulatory approval for children aged 6 to under 12. The company said the STEP Young trial was conducted in accordance with regulatory authorities’ post-marketing requirements associated with the semaglutide Phase 3 development program. With 40.4% of treated children moving below the obesity classification threshold at week 68 compared with none in the placebo group, the results provide a significant clinical signal for Novo Nordisk’s pediatric obesity strategy. Further data presentation at ObesityWeek 2026 is expected to provide a more comprehensive view of the program’s clinical outcomes.
Source: Novo Nordisk, press relese
