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A Trial of Setmelanotide in Acquired Hypothalamic Obesity
Sponsor: Rhythm Pharmaceuticals, Inc.
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.
Official title: A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity
Key Details
Gender
All
Age Range
4 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2023-04-26
Completion Date
2027-04-16
Last Updated
2025-07-02
Healthy Volunteers
No
Conditions
Interventions
Setmelanotide
Solution for daily subcutaneous injection
Placebo
Placebo matched to setmelanotide for daily subcutaneous injection
Locations (28)
UAN Pediatric Endocrinology
Birmingham, Alabama, United States
Rady Children's Hospital
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, United States
University of Iowa Stead Family Department of Pediatrics
Iowa City, Iowa, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Children's Minnesota
Saint Paul, Minnesota, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Ohio State Wexner Medical Center
Columbus, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Vanderbilt University School of Medicine
Nashville, Tennessee, United States
Seattle Children's Hospital, Research and Foundation - Center for Integrative Brain Research
Seattle, Washington, United States
Hospital for Sick Children
Toronto, Ontario, Canada
Universitaetsklinikum Hamburg-Eppendorf (UKE) - Ambulanzzentrum des UKE GmbH
Hamburg, Germany
Medicover Neuroendokrinologie
München, Germany
University Children's Hospital, Klinikum Oldenburg
Oldenburg, Germany
Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin
Ulm, Germany
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Nagano Children's Hospital
Azumino, Nagano, Japan
Toranomon Hospital
Minato, Tokyo, Japan
Prinses Maxima Center for Pediatric Oncology
Utrecht, Netherlands
Birmingham Women and Children's Hospital NHS Trust
Birmingham, United Kingdom
Hull University Teaching Hospital
Hull, United Kingdom
UCL Great Ormond Street Institute of Child Health
London, United Kingdom