A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity
Rhythm Pharmaceuticals, Inc.
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.
Eligibility
- Age range
- 4+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1. Diagnosis of multiple pituitary hormone deficiency (MPHD), or septo-optic dysplasia (SOD), or optic nerve hypoplasia (ONH), or Childhood-onset combined pituitary hormone deficiency (CPHD), or Pituitary Stalk Interruption Syndrome (PSIS) with at least one pituitary deficiency AND a body mass index (BMI) of ≥30 kg/m2 for patients ≥18 years of age, or BMI ≥95th percentile for age and sex for patients 4 to \<18 years 2. Age 4 years and older 3. Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentil…
Interventions
- DrugSetmelanotide
Solution for daily subcutaneous injection
- DrugPlacebo
Placebo matched to setmelanotide for daily subcutaneous injection
Locations (11)
- University of AlabamaBirmingham, Alabama
- Children's Hospital ColoradoAurora, Colorado
- Lurie Children's HospitalChicago, Illinois
- Boston Children's HospitalBoston, Massachusetts
- Children's MinnesotaSaint Paul, Minnesota
- Columbia University Irving Medical CenterNew York, New York