Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774756
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-29
First Post:
2023-03-01
Brief Title:
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
Sponsor:
Rhythm Pharmaceuticals Inc
Organization:
Rhythm Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 3 Double Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity
Status:
ENROLLING_BY_INVITATION
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:
The goal of this trial is to learn how well Setmelanotide works to improve weight reduction hunger and quality of life in patients 4 years of age and older with acquired Hypothalamic Obesity HO To determine how well setmelanotide works and how safe it is patients with HO will take a daily injection of either setmelanotide or placebo and complete trial assessments for up to 60 weeks
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