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RM-493-042

  • Status
    Accepting Candidates
  • Age
    2 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

This is an open-label extension study designed to evaluate the long-term safety and tolerability of continued setmelanotide treatment in male and female patients 鈮�2 years of age who have completed or transitioned from a previous study with setmelanotide for rare genetic, syndromic, or acquired diseases of obesity upstream of the MC4R pathway.

Details

Full study title Open-Label Extension Study of Setmelanotide in Patients with a Rare Genetic, Syndromic or Acquired Disease of the MC4R Pathway
Protocol number OCR46541
ClinicalTrials.gov ID NCT06596135
Phase Phase 3

Eligibility

Key Inclusion Criteria:

  • Males and females 鈮�2 years of age who have completed a previous setmelanotide clinical study and who have a condition or indication for which Rhythm plans further clinical development.

  • Agree to use a highly effective form of contraception and follow the study contraception requirements throughout study duration and for 90 days after.

  • Demonstrated clinical benefit in the previous setmelanotide study, as determined by the Investigator.

Key Exclusion Criteria:

  • Any gene variant, syndromic, or acquired disease for which setmelanotide is currently approved in the United States (i.e., patients eligible for commercial setmelanotide (IMCIVREE庐).

  • Any new or worsening depression resulting in suicidal thoughts and/or behaviors.

  • Discontinuation from a previous setmelanotide study.

  • History or close family history (parents or siblings) of melanoma.

  • Pregnant and/or breastfeeding women

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
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    Participate

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