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RM-493-043

  • Status
    Accepting Candidates
  • Age
    6 Years - 65 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Details

Full study title A Phase 2, Single center, Open-label Study of Setmelanotide in Patients with Prader-Willi Syndrome
Protocol number OCR46920
ClinicalTrials.gov ID NCT06772597
Phase Phase 2

Eligibility

Key Inclusion 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.

Exclusion Criteria:

  • 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

Other protocol defined Inclusion/Exclusion criteria may apply.

Lead researcher

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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