Open-Label Extension Study of Setmelanotide

Phase 3Enrolling By InvitationNCT06596135

Rhythm Pharmaceuticals, Inc.30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity Associated With Defects in Leptin-melanocortin Pathway

Interventions

SetmelanotideDRUG

Open-label daily injections of setmelanotide

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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.

Locations (13)

HonorHealth Research Institute

Scottsdale, Arizona, United States

UC San Diego- Rady Children's Hospital

San Diego, California, United States

University of Florida at Gainesville

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: Up to 3 years

Data from ClinicalTrials.gov

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