Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05726227
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-02-03
Brief Title:
A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
Long-term Safety and Efficacy of Semaglutide sc Once-weekly on Weight Management in Children and Adolescents Aged 6 to 18 Years With Obesity or Overweight
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEP Young
Brief 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 childs 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1266-3808 | OTHER | None | None |
| 2022-502922-41 | EUDRACT_NUMBER | World Health Organization WHO | None |