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Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity

Study acronym: REAL-MC4
StatusRecruiting
PhasePhase 4
SponsorTom Hühne
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
Bardet-Biedl syndrome (BBS) and other rare disorders associated with impairment of the melanocortin-4 receptor (MC4R) pathway are characterized by severe early-onset obesity, hyperphagia, and substantial morbidity. Setmelanotide, an MC4R agonist, is approved in Europe for selected genetic obesity disorders and reimbursed in Germany for eligible patients. This study aims to evaluate the effectiveness, safety, treatment persistence, metabolic outcomes, and patient-reported outcomes of Setmelanotide under real-world conditions. The registry is designed to allow future inclusion of additional MC4R agonists as they become approved and clinically available. The study will primarily be conducted at University Hospital Essen and will collect longitudinal routine clinical data from pediatric and adult patients receiving MC4R agonist therapy according to approved indications.
Trial Details
NCT Number NCT07674290
Lead Sponsor Tom Hühne
Collaborators: Rhythm Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Bardet Biedl Syndrome (BBS), Bardet Biedl Syndrome, Bardet-Biedl Syndrome (BBS), Alstrom Syndrome
Related terms Alstrom Syndrome, Bardet-Biedl Syndrome, Hyperphagia
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov