At a glance
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A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity
In Brief
A Phase 3 clinical trial evaluating Setmelanotide and Placebo for Hypothalamic Obesity. Active but no longer recruiting, targeting 143 participants across 28 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
Solution for daily subcutaneous injection
Placebo matched to setmelanotide for daily subcutaneous injection