Ignite Creation Date:
2024-05-06 @ 9:04 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02896192
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2016-08-18
Brief Title:
Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin POMC Deficiency Obesity
Sponsor:
Rhythm Pharmaceuticals Inc
Organization:
Rhythm Pharmaceuticals Inc
Study Overview
Official Title:
An Open-Label 1-Year Trial Including a Double-Blind Placebo-Controlled Withdrawal Period of Setmelanotide RM-493 a Melanocortin 4 Receptor MC4R Agonist in Early Onset POMC Deficiency Obesity Due to Bi-Allelic Loss-of-Function POMC or PCSK1 Genetic Mutation
Status:
COMPLETED
Status Verified Date:
2023-08
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:
To demonstrate statistically significant and clinically meaningful effects of setmelanotide on percent body weight change in participants with pro-opiomelanocortin POMC deficiency or proprotein convertase subtilisinkexin type 1 PCSK1 deficiency obesity due to rare biallelic or loss-of function mutations at the end of 1 year of treatment
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 |
|---|---|---|---|
| 2016-002320-83 | EUDRACT_NUMBER | None | None |