RECRUITING

A Study of Setmelanotide in Patients With Prader-Willi Syndrome

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Conditions

Prader-Willi SyndromeObesityHyperphagiamelanocortin 4 receptor (MC4R), MC4R agonist

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 2, open-label study designed to assess the safety and efficacy of setmelanotide in patients with obesity due to Prader-Willi Syndrome (PWS) who are 6 to 65 years of age. Up to 20 patients are planned to be enrolled. Patients will take a daily subcutaneous dose of open-label setmelanotide for up to 52 weeks.

Official Title

A Phase 2 Open-label Study of Setmelanotide in Patients With Prader-Willi Syndrome

Quick Facts

Study Start:2025-03-04
Study Completion:2027-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06772597

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of Prader-Willi Syndrome (PWS)
  2. * Age 6 to 65
  3. * BMI ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th Percentile for age and sex
  4. * Agree to use a highly effective form of contraception and follow the study contraception requirements throughout study duration and for 90 days after.
  5. * 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.
  1. * Use of weight modulating medications
  2. * Abnormal HbA1c, eGFR, ALT, AST, bilirubin, T4 values
  3. * Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease considered severe enough to interfere with the trial and/or confound the results.
  4. * 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
  5. * Hypersensitivity to setmelanotide
  6. * Diagnosis of severe psychiatric disorders
  7. * Pregnant and/or breastfeeding

Contacts and Locations

Study Contact

Rhythm Clinical Trials
CONTACT
(857) 264-4280
clinicaltrials@rhythmtx.com
Physician Inquiry Clinical Trials
CONTACT
(857) 264-4280
clinicaltrials@rhythmtx.com

Principal Investigator

David Meeker, MD
STUDY_CHAIR
Rhythm Pharmaceuticals, Inc.

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32610-0296
United States

Collaborators and Investigators

Sponsor: Rhythm Pharmaceuticals, Inc.

  • David Meeker, MD, STUDY_CHAIR, Rhythm Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-04
Study Completion Date2027-10-31

Study Record Updates

Study Start Date2025-03-04
Study Completion Date2027-10-31

Terms related to this study

Keywords Provided by Researchers

  • melanocortin 4 receptor (MC4R), MC4R agonist

Additional Relevant MeSH Terms

  • Prader-Willi Syndrome
  • Obesity
  • Hyperphagia