Setmelanotide in Pediatric Patients With Rare Genetic Diseases of Obesity

Bardet-Biedl Syndrome Clinical Trial

Official title: A Phase 3 Multi-Center, One-Year, Open-Label Study of Setmelanotide in Pediatric Patients Aged 2 to <6 Years of Age With Rare Genetic Causes of Obesity

Status Completed

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. ;

Related Conditions & MeSH terms

• Bardet-Biedl Syndrome
• LEPR Deficiency Obesity
• Obesity
• PCSK1 Deficiency Obesity
• POMC Deficiency Obesity

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