Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04775082
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2021-02-26
Brief Title:
SCALE KIDS Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
Effect and Safety of Liraglutide 30 mg on Weight Management in Children With Obesity Aged 6 to Below 12 Years 56-week Double-blind Randomised Placebo-controlled Trial
Status:
ACTIVE_NOT_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:
None
Brief Summary:
The study looks at how liraglutide works on participants body weight Researchers will look at how liraglutide can help children with obesity to lose weight They will look at how much weight the children will lose and if there are any side effects
Participants will either get liraglutide or placebo Which treatment the participants get is decided by chance Liraglutide is a new medicine for children but it can already be prescribed by doctors to adults with overweight or obesity The participant will get 1 injection every day
In addition to taking the medicine the participants will have talks with the study staff about healthy food choices how they can be more physically active and what can be done to help the participants to lose weight
The study will last for about 96 weeks almost 2 years The participants will have 18 clinic visits and 10 phone or video calls with the study doctorstaff Participant will have blood samples taken have 1 test to check the heart 1 hand X-ray taken and must fill in a diary between some of the visits
Participants will either get liraglutide or placebo Which treatment the participants get is decided by chance Liraglutide is a new medicine for children but it can already be prescribed by doctors to adults with overweight or obesity The participant will get 1 injection every day
In addition to taking the medicine the participants will have talks with the study staff about healthy food choices how they can be more physically active and what can be done to help the participants to lose weight
The study will last for about 96 weeks almost 2 years The participants will have 18 clinic visits and 10 phone or video calls with the study doctorstaff Participant will have blood samples taken have 1 test to check the heart 1 hand X-ray taken and must fill in a diary between some of the visits
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 |
|---|---|---|---|
| U1111-1247-8226 | OTHER | None | None |
| 2020-000546-34 | REGISTRY | European Medicines Agency EudraCT | None |