By InvitationPhase 3

Open-Label Extension Study of Setmelanotide

United States30 participantsStarted 2024-10-21

Plain-language summary

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.

Who can participate

Age range2 Years

SexALL

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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.

What they're measuring

Safety and tolerability of setmelanotide assessed by frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Up to 3 years

Trial details

NCT IDNCT06596135

SponsorRhythm Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10-30