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Clinical Trial Summary

This is a phase 3 open-label, one-arm, clinical study to evaluate the efficacy, safety and tolerability of setmelanotide over 1 year of treatment, in pediatric patients aged 2 to <6 years with obesity due to either biallelic variants of the POMC, PCSK1 or LEPR genes or Bardet-Biedl Syndrome (BBS).


Clinical Trial Description

Pediatric patients aged 2 to <6 years with obesity due to either biallelic variants of the POMC, PCSK1 or LEPR genes or Bardet-Biedl Syndrome (BBS) will be enrolled into this phase 3 open-label clinical trial at one of approximately 8 clinical centers in North America, Europe, or Australia. All patients will be assigned to receive setmelanotide via daily subcutaneous injection for 1 year. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04966741
Study type Interventional
Source Rhythm Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 3
Start date February 16, 2022
Completion date September 19, 2023

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