A Trial of Setmelanotide in Acquired Hypothalamic Obesity
NCT ID: NCT05774756
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2023-04-26
2027-04-16
Brief Summary
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A separate sub-study in patients with congenital HO is detailed under NCT06760546.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Setemelanotide
Randomized 2:1 (Setmelanotide: Placebo)
Setmelanotide
Solution for daily subcutaneous injection
Placebo
Randomized 2:1 (Setmelanotide: Placebo)
Placebo
Placebo matched to setmelanotide for daily subcutaneous injection
Interventions
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Setmelanotide
Solution for daily subcutaneous injection
Placebo
Placebo matched to setmelanotide for daily subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 \<18 years of age
4. Agree to use a highly effective form of contraception throughout the study and for 90 days after the study
Exclusion Criteria
2. Weight loss \>2% in the previous 3 months for patients aged ≥18 years or \>2% reduction in BMI for patients aged 4 to \<18 years
3. Bariatric surgery or procedure within last 2 years
4. Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior
5. Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease
6. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
7. History or close family history of skin cancer or melanoma
8. Participation in any clinical trial with an investigational drug/device within 3 months prior to the first trial dose
9. Previously enrolled in a clinical trial involving setmelanotide or any previous exposure to setmelanotide
10. Inability to comply with once daily (QD) injection regimen
11. If female, pregnant and/or breastfeeding
12. Patients with obesity attributable to other genetic or syndromic conditions (eg, PPL \[POMC, PCSK1, LEPR, collectively\], BBS) prior to the hypothalamic injury.
13. If receiving hormone replacement therapy, dose has remained stable for at least 2 months before Screening
4 Years
ALL
No
Sponsors
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Rhythm Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Meeker, MD
Role: STUDY_CHAIR
Rhythm Pharmaceuticals, Inc.
Locations
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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
Countries
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Other Identifiers
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RM-493-040
Identifier Type: -
Identifier Source: org_study_id
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