NCT05726227

A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight

Long-term Safety and Efficacy of Semaglutide s.c. Once-weekly on Weight Management in Children and Adolescents (Aged 6 to <18 Years) With Obesity or Overweight

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look at how well semaglutide helps children and teenagers losing weight. This will be tested by comparing the effect on body weight in children and teenagers taking semaglutide in comparison to placebo, a "dummy" medicine. In addition to taking the medicine, the child's parent and the child will have talks with study staff about healthy food choices, how to be more physically active and what your child can do to try to lose weight. The child will either get semaglutide or a "dummy" medicine. Which treatment the child will get is decided by chance. Semaglutide is an approved medicine for type 2 diabetes and weight management in adults. The child will get one injection once a week. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. The study will last for about 2 ½ years (132 weeks).

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Semaglutide	Semaglutide will be administered subcutaneously once weekly.
DRUG	Placebo	Placebo will be administered subcutaneously once-weekly.

Timeline

• Start date: 2023-07-07
• Primary completion: 2025-10-15
• Completion: 2026-12-07
• First posted: 2023-02-13
• Last updated: 2025-11-24

Locations

56 sites across 10 countries: United States, Austria, Belgium, Denmark, Germany, Israel, Mexico, Portugal, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study