Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548100
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy GLD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-Arm Open-Label Safety Study in Patients With Generalized Lipodystrophy Switching From Metreleptin to Mibavademab A Leptin Receptor Agonist Antibody
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is researching an experimental drug called mibavademab The study is focused on participants with GLD who have been on metreleptin treatment for at least 6 months with no change in dose for the last 3 months
The aim of the study is to see how safe and tolerable mibavademab is when switching from treatment with metreleptin
The study is looking at several other research questions including
What side effects may happen from taking mibavademab
How much mibavademab is in the blood at different times
Whether the body makes antibodies against mibavademab which could make mibavademab less effective or could lead to side effects
The aim of the study is to see how safe and tolerable mibavademab is when switching from treatment with metreleptin
The study is looking at several other research questions including
What side effects may happen from taking mibavademab
How much mibavademab is in the blood at different times
Whether the body makes antibodies against mibavademab which could make mibavademab less effective or could lead to side effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None