Open-Label Extension Study of Setmelanotide

Launched by RHYTHM PHARMACEUTICALS, INC. · Sep 13, 2024

Keywords

ClinConnect Summary

This is an open-label extension study of setmelanotide (also called RM-493 or Imcivree) to see how safe and tolerable it is to continue this treatment over the long term in people 2 years and older who have obesity linked to rare genetic, syndromic, or MC4R pathway conditions. It’s a Phase 3, single-group trial where all participants know they are receiving the drug and will inject it once daily under the skin. Researchers will track side effects and any serious safety events for up to about 3 years, with about 30 people expected to enroll at multiple sites around the United States.

Eligibility focuses on people who completed a prior setmelanotide study and have a condition that Rhythm plans to study further, and who have shown some clinical benefit from the drug before. Participants must use a highly effective contraception method during the study and for 90 days after, and they must meet other inclusion criteria while not meeting key exclusions (for example, they are not eligible if they could receive the commercial product IMCIVREE, if they have active depression with suicidal thoughts, if they are pregnant or breastfeeding, or if they discontinued a previous study). The study started around October 2024 and is expected to finish around October 2027, with sites across the U.S. and sponsored by Rhythm Pharmaceuticals.

Gender

ALL

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.