A Trial of Setmelanotide in Acquired Hypothalamic Obesity
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Hypothalamic Obesity
In brief
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.
Key facts
- Study ID
- NCT05774756
- Run by
- Rhythm Pharmaceuticals, Inc.
- People needed
- 143
- Starts
- 2023-04-26
- Expected to finish
- 2027-04-16
- Last updated by the study team
- 2026-05-29
Who can join
Age: 4 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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