Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596135
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Open-Label Extension Study of Setmelanotide
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Open-Label Extension Study of Setmelanotide in Patients With a Rare Genetic Syndromic or Acquired Disease of the MC4R Pathway
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label extension study designed to evaluate the long-term safety and tolerability of continued setmelanotide treatment in male and female patients 2 years of age who have completed or transitioned from a previous study with setmelanotide for rare genetic syndromic or acquired diseases of obesity upstream of the MC4R pathway
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