A Trial of Setmelanotide in Acquired Hypothalamic Obesity

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

April 26, 2023

Primary Completion Date

March 18, 2025

Study Completion Date

April 16, 2027

Conditions
Hypothalamic Obesity
Interventions
DRUG

Setmelanotide

Solution for daily subcutaneous injection

DRUG

Placebo

Placebo matched to setmelanotide for daily subcutaneous injection

Trial Locations (28)

10032

Columbia University Irving Medical Center, New York

19104

Children's Hospital of Philadelphia, Philadelphia

20246

Universitaetsklinikum Hamburg-Eppendorf (UKE) - Ambulanzzentrum des UKE GmbH, Hamburg

26133

University Children's Hospital, Klinikum Oldenburg, Oldenburg

35233

UAN Pediatric Endocrinology, Birmingham

37232

Vanderbilt University School of Medicine, Nashville

43203

Ohio State Wexner Medical Center, Columbus

52242

University of Iowa Stead Family Department of Pediatrics, Iowa City

55102

Children's Minnesota, Saint Paul

60611

Ann and Robert H. Lurie Children's Hospital, Chicago

73122

Lynn Health Science Institute, Oklahoma City

80045

Children's Hospital Colorado, Aurora

81667

Medicover Neuroendokrinologie, München

89075

Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin, Ulm

92123

Rady Children's Hospital, San Diego

98101

Seattle Children's Hospital, Research and Foundation - Center for Integrative Brain Research, Seattle

100029

Icahn School of Medicine at Mount Sinai, New York

32610-0296

University of Florida, Gainesville

02115

Boston Children's Hospital, Boston

Brigham and Women's Hospital, Boston

M5G 1X8

Hospital for Sick Children, Toronto

467-8602

Nagoya City University Hospital, Nagoya

399-8288

Nagano Children's Hospital, Azumino

105-8470

Toranomon Hospital, Minato

3584CS

Prinses Maxima Center for Pediatric Oncology, Utrecht

B46NH

Birmingham Women and Children's Hospital NHS Trust, Birmingham

HU32RW

Hull University Teaching Hospital, Hull

WC1N 1EH

UCL Great Ormond Street Institute of Child Health, London

All Listed Sponsors
lead

Rhythm Pharmaceuticals, Inc.

INDUSTRY