Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT06596135
Eligibility Criteria:
Key Inclusion Criteria:
* Males and females ≥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®).
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT06596135
Study Brief:
Protocol Section:
NCT06596135