Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2026-02-22 @ 5:23 PM
Study NCT ID:
NCT02041195
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2014-01-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients
Sponsor:
Rhythm Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Staged, Phase 1b/Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Efficacy of RM-493, a Melanocortin 4 Receptor (MC4R) Agonist in Obese Patients Using a Once or Twice Daily Sub-Cutaneous Injection Formulation
Status:
COMPLETED
Status Verified Date:
2023-07
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 purpose of this study is to evaluate the effects of a new daily subcutaneous (SC) injectable formulation of setmelanotide (RM-493) in healthy participants with obesity on mean percent body weight loss and other weight loss parameters, as well as pharmacokinetic (PK) profile. The study is designed to evaluate the efficacy and tolerability of setmelanotide administered once or twice daily. The study drug (setmelanotide and placebo) will be administered in a blinded fashion.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: