Trials / Recruiting
RecruitingNCT06760546
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- Sponsor
- Rhythm Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 4 Years
- Healthy volunteers
- Not accepted
Summary
This is a sub-study of Study RM-493-040 (NCT05774756). The goal of this sub-study 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 congenital Hypothalamic Obesity (cHO). To determine how well setmelanotide works and how safe it is, patients with cHO will take a daily injection of either setmelanotide or placebo and complete trial assessments for up to 26 weeks on a therapeutic regimen.
Conditions
- Hypothalamic Obesity
- Multiple Pituitary Hormone Deficiency Genetic Form
- Septo-Optic Dysplasia
- Optic Nerve Hypoplasia
- Childhood-onset Combined Pituitary Hormone Deficiency
- Pituitary Stalk Interruption Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Setmelanotide | Solution for daily subcutaneous injection |
| DRUG | Placebo | Placebo matched to setmelanotide for daily subcutaneous injection |
Timeline
- Start date
- 2025-09-23
- Primary completion
- 2027-03-13
- Completion
- 2028-03-13
- First posted
- 2025-01-07
- Last updated
- 2026-02-12
Locations
11 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06760546. Inclusion in this directory is not an endorsement.