A Single-center Study of Setmelanotide in Patients With Prader-Willi Syndrome

Description

This is a Phase 2, single-center, 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 26 weeks.

Conditions

Prader-Willi Syndrome, Obesity, Hyperphagia

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Study Overview

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Study Details

Study overview

This is a Phase 2, single-center, 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 26 weeks.

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

A Single-center Study of Setmelanotide in Patients With Prader-Willi Syndrome

Condition
Prader-Willi Syndrome
Intervention / Treatment

-

Contacts and Locations

Gainesville

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Confirmed diagnosis of Prader-Willi Syndrome (PWS)
  • * 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.
  • * Use of weight modulating medications
  • * 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

Ages Eligible for Study

6 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rhythm Pharmaceuticals, Inc.,

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

Study Record Dates

2026-01-31