Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Patients With Specific Gene Defects in the MC4R Pathway

Bardet-Biedl Syndrome Clinical Trial

Official title:
A Phase 3, Randomized, Double-Blind Trial of Two Formulations of Setmelanotide (Daily and Weekly) With a Crossover to Open-Label Once Weekly Setmelanotide in Patients With Specific Gene Defects in the Melanocortin-4 Receptor Pathway Who Are Currently on a Stable Dose of the Once Daily Formulation

Status Completed

Clinical Trial Summary

A trial to compare the weekly and daily formulations of setmelanotide in patients with genetic defects in the melanocortin-4 receptor pathway.

Clinical Trial Description

This study is designed to compare the safety, pharmacokinetics, and efficacy of weekly and daily formulations of setmelanotide in patients with obesity associated with biallelic or heterozygous POMC (pro-opiomelanocortin), PCSK1 (proprotein convertase subtilisin/kexin Type 1), LEPR (leptin receptor) genetic variants, and patients with Bardet-Biedl Syndrome (BBS). ;

Study Design

Related Conditions & MeSH terms

Bardet-Biedl Syndrome

Clinical Trial Details

NCT number	NCT05194124
Study type	Interventional
Source	Rhythm Pharmaceuticals, Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	December 21, 2021
Completion date	October 19, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04874909` - Classification, Functional Stratification and Biomarkers in Ciliopathy (CILLICORIRCM)	N/A
Recruiting	`NCT02329210` - Clinical Registry Investigating Bardet-Biedl Syndrome
Recruiting	`NCT02435940` - Inherited Retinal Degenerative Disease Registry
Completed	`NCT00213811` - Bardet-Biedl Syndrome Study: Clinical and Genetic Epidemiology Study in Adults	N/A
Recruiting	`NCT04461444` - COhort for Bardet-Bield Syndrome and Alström Syndrome for Translational Research Monocentric Interventional Study	N/A
Recruiting	`NCT06239064` - Early Genetic Identification of Obesity
Terminated	`NCT00078091` - Genetics and Clinical Characteristics of Bardet-Biedl Syndrome
Completed	`NCT04966741` - Setmelanotide in Pediatric Patients With Rare Genetic Diseases of Obesity	Phase 3
Enrolling by invitation	`NCT05400278` - Characterizing the Genotype and Phenotype in Adults With Bardet-Biedl Syndrome
Withdrawn	`NCT03490019` - Treatment of Bardet-Biedl-Syndrome With Metformin for Evaluation of a Possible Visual Improvement	Phase 2