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

NCT05726227 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-04-23

No results posted yet for this study

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

Interventions

DRUG

Placebo

Placebo will be administered subcutaneously once-weekly.

DRUG

Semaglutide

Semaglutide will be administered subcutaneously once weekly.

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency dept. 2834 · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-07
Primary Completion
2025-10-15
Completion
2026-12-07
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Denmark
  • Germany
  • Israel
  • Mexico
  • Portugal
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05726227 on ClinicalTrials.gov