NCT05726227 (STEP Young) is a Phase 3 clinical trial of Semaglutide in Obesity, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT05726227?

NCT05726227 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT05726227?

Interventions in NCT05726227: Semaglutide, Placebo.

Is NCT05726227 still recruiting?

NCT05726227 is currently active, enrolled. Last updated 24 November 2025.

Last reviewed 2025-11-24 · How we verify

NCT05726227: STEP Young

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 3 Last updated 24 November 2025

What this trial tests

Phase 3 trial testing Semaglutide in Obesity in 210 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

7 July 2023

Primary endpoint
15 October 2025

7 December 2026

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	210
Start date	7 July 2023
Primary completion	15 October 2025
Estimated completion	7 December 2026
Sites	56 locations across Belgium, Germany, United States, Austria, Sweden, Israel, Mexico, United Kingdom

Drugs / interventions tested

Semaglutide (semaglutide) — full drug profile →
Placebo

Conditions studied

Obesity — all drugs for Obesity →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 6 to 18, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Semaglutide for management of obesity in adolescents: efficacy, safety, and considerations for clinical practice.
Bensignor MO, Arslanian S, Vajravelu ME. · · 2024 · cited 5× · PMID 38774967 · DOI 10.1097/mop.0000000000001365
Special considerations for the child with obesity: An Obesity Medicine Association (OMA) clinical practice statement (CPS) 2024.
Cuda S, Censani M, O'Hara V, Paisley J, et al · · 2024 · cited 4× · PMID 38953014 · DOI 10.1016/j.obpill.2024.100113
Extinguishing the Fire: Treating Pediatric Type 2 Diabetes by Targeting Obesity Treatment.
Bensignor MO, Hsia DS, Van Name MA, Jastreboff AM, et al · · 2025 · PMID 40730197 · DOI 10.2337/dci25-0031

Verify or expand the search:

Other trials of Semaglutide

Trials testing the same drug.

NCT07430332 — GLP-1 RA for Stage 1 Type 1 Diabetes · Phase 2 · not yet recruiting
NCT06977438 — Promoting Healthy Children and Youth · Phase 4 · not yet recruiting
NCT07218354 — Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial · Phase 3 · not yet recruiting
NCT07511543 — Glucagon-like Peptide-1 Receptor Agonists for Endovascular Stroke Thrombectomy · Phase 2 · not yet recruiting
NCT07570810 — Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM · NA · not yet recruiting

Other recruiting trials for Obesity

Currently open trials in the same condition.

NCT07403604 — Effect of Insulin Lowering on Lipogenesis · Phase 1 · recruiting
NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee · Phase 3 · recruiting
NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
NCT07481630 — A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoart · Phase 3 · recruiting
NCT07527195 — Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscl · Phase 1 · recruiting

Other Novo Nordisk A/S trials

Trials by the same sponsor.

NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05726227 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 24 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05726227.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing