Trials / Active Not Recruiting
Active Not RecruitingNCT05774756
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Rhythm Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 4 Years
- Healthy volunteers
- Not accepted
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 52 weeks on a therapeutic regimen. A separate sub-study in patients with congenital HO is detailed under NCT06760546.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Setmelanotide | Solution for daily subcutaneous injection |
| DRUG | Placebo | Placebo matched to setmelanotide for daily subcutaneous injection |
Timeline
- Start date
- 2023-04-26
- Primary completion
- 2025-03-18
- Completion
- 2027-04-16
- First posted
- 2023-03-20
- Last updated
- 2025-07-02
Locations
28 sites across 6 countries: United States, Canada, Germany, Japan, Netherlands, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05774756. Inclusion in this directory is not an endorsement.