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Active Not Recruiting
NCT05774756
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
Conditions: Hypothalamic Obesity
Sex: All
Ages: 4 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 143
Sponsor: Rhythm Pharmaceuticals, Inc.
Location: UAN Pediatric Endocrinology Birmingham Alabama
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.
Eligibility Criteria
Key Inclusion Criteria:
1. Documented evidence of acquired hypothalamic obesity (HO)
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 percentile for age and sex for patients 4 to \2% in the previous 3 months for patients aged ≥18 years or \>2% reduction in BMI for patients aged 4 to \
Source: ClinicalTrials.gov (NCT05774756). StuddyBuddy aggregates publicly available trial information.
