NCT04102189

A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

Effect and Safety of Semaglutide 2.4 mg Once Weekly on Weight Management in Adolescents With Overweight or Obesity

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study will look at the change in teenagers' body weight from the start to the end of the study. This is to compare the effect on body weight in teenagers taking semaglutide (a new medicine) and teenagers taking "dummy" medicine. The teenagers in the study and their parents will also have talks with study staff about healthy food choices, how to be more physically active and what they can do to help the teenagers lose weight. The teenagers will either get semaglutide or "dummy" medicine - which treatment is decided by chance. The teenagers will take 1 injection every week, on the same day of the week for about 15 months. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The teenagers will have 17 clinic visits, will have blood samples taken and will have to complete questionnaires and keep a diary. All this will be explained before study start.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DRUG	Semaglutide	Participants will receive semaglutide s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks
OTHER	Placebo	Participants will receive semaglutide placebo s.c. once weekly for a total of 68 weeks

Timeline

• Start date: 2019-10-07
• Primary completion: 2022-03-25
• Completion: 2022-03-28
• First posted: 2019-09-25
• Last updated: 2025-12-11
• Results posted: 2023-04-18

Locations

51 sites across 8 countries: United States, Austria, Belgium, Croatia, Ireland, Mexico, Russia, United Kingdom

Regulatory

• FDA-regulated drug study