Open-Label Extension Study of Setmelanotide

Rhythm Pharmaceuticals

Status and phase

Invitation-only

Phase 3

Conditions

Obesity Associated With Defects in Leptin-melanocortin Pathway

Treatments

Drug: Setmelanotide

Study type

Interventional

Funder types

Industry

Identifiers

NCT06596135

RM-493-042

Details and patient eligibility

About

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 ≥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.

Enrollment

30 estimated patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.