Trials / Enrolling By Invitation
Enrolling By InvitationNCT06596135
Open-Label Extension Study of Setmelanotide
Open-Label Extension Study of Setmelanotide in Patients With a Rare Genetic, Syndromic or Acquired Disease of the MC4R Pathway
- Status
- Enrolling By Invitation
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Rhythm Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Setmelanotide | Open-label daily injections of setmelanotide |
Timeline
- Start date
- 2024-10-21
- Primary completion
- 2027-10-30
- Completion
- 2027-10-30
- First posted
- 2024-09-19
- Last updated
- 2025-09-04
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06596135. Inclusion in this directory is not an endorsement.