A Study of Setmelanotide in Patients With Prader-Willi Syndrome
NCT ID: NCT06772597
Last Updated: 2025-10-15
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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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2025-03-04
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Setmelanotide (Open-label)
Setmelanotide
Setmelanotide (daily subcutaneous injection)
Interventions
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Setmelanotide
Setmelanotide (daily subcutaneous injection)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 6 to 65
* BMI ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th Percentile for age and sex
* Agree to use a highly effective form of contraception and follow the study contraception requirements throughout study duration and for 90 days after.
* Patient and/or guardian is able to communicate well with the Investigator, understand and comply with the requirements of the study, and understand English and sign the written informed consent.
Exclusion Criteria
* Abnormal HbA1c, eGFR, ALT, AST, bilirubin, T4 values
* Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease considered severe enough to interfere with the trial and/or confound the results.
* Participation in any clinical trial with an investigational drug/device within 3 months or 5 half-lives, whichever is longer, prior to the first trial dose
* Hypersensitivity to setmelanotide
* Diagnosis of severe psychiatric disorders
* Pregnant and/or breastfeeding
6 Years
65 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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University of Florida
Gainesville, Florida, United States
Countries
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Central Contacts
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Other Identifiers
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RM-493-043
Identifier Type: -
Identifier Source: org_study_id
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