Ignite Creation Date:
2024-05-06 @ 4:21 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04966741
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2021-03-29
Brief Title:
Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity
Sponsor:
Rhythm Pharmaceuticals Inc
Organization:
Rhythm Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 3 Multi-Center 1-Year Open-Label Study of Setmelanotide in Pediatric Patients Aged 2 to 6 Years of Age With Rare Genetic Causes of Obesity
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
This is a phase 3 open-label clinical study to evaluate the efficacy safety and tolerability of setmelanotide over 1 year of treatment in pediatric participants aged 2 to 6 years with obesity due to either biallelic variants of the pro-opiomelanocortin POMC proprotein convertase subtilisinkexin type 1 PCSK1 or leptin receptor LEPR genes or Bardet-Biedl Syndrome BBS
Detailed Description:
Pediatric participants aged 2 to 6 years with obesity due to either biallelic variants of the POMC PCSK1 or LEPR genes or BBS will be enrolled into this phase 3 open-label clinical trial at one of approximately 8 clinical centers in North America Europe or Australia All participants will be assigned to receive setmelanotide via daily subcutaneous SC injection for 1 year
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