Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-03-09 @ 1:59 AM
Study NCT ID:
NCT02507492
Status:
UNKNOWN
Last Update Posted:
2016-02-22
First Post:
2015-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RM-493 Treatment Trial in Proopiomelanocortin (POMC) Deficient Patients
Sponsor:
Charite University, Berlin, Germany
Organization:
Study Overview
Official Title:
RM-493 Treatment Trial in Proopiomelanocortin (POMC) Deficient Patients
Status:
UNKNOWN
Status Verified Date:
2016-02
Last Known Status:
RECRUITING
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 purpose of this study is to evaluate the effects of a once daily subcutaneous (SC) injection of RM-493, in subjects with POMC (propiomelanocortin) or other related rare genetic mutations, on body weight, metabolic function and blood pressure. Patients who respond during the initial 84 days of treatment can enter into long-term (2-year) extensions. The study drug (RM-493) will be administered in an unblinded fashion.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2014-002392-28 | EUDRACT_NUMBER | None | View |