EICHORCondition: Obesity Associated With Defects in Leptin-melanocortin Pathway · Sponsor: Rhythm Pharmaceuticals, Inc.
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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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| 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 | — |
| University of Michigan | Ann Arbor, Michigan, United States | — |
| Mayo Clinic - Rochester | Rochester, Minnesota, United States | — |
| Children's Minnesota | Saint Paul, Minnesota, United States | — |
| University of Buffalo | Getzville, New York, United States | — |
| M3 Wake Research, Inc | Raleigh, North Carolina, United States | — |
| Geisinger Health System | Danville, Pennsylvania, United States | — |
| WR-ClinSearch | Chattanooga, Tennessee, United States | — |
| Vanderbilt University School of Medicine | Nashville, Tennessee, United States | — |
| Seattle Children's Research Institute | Seattle, Washington, United States | — |
+ 1 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06596135