NCT07674290 Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity
| NCT ID | NCT07674290 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Tom Hühne |
| Condition | Bardet Biedl Syndrome (BBS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2023-01-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * clinical phenotype corresponding to Bardet-Biedl Syndrome * genetic testing with notable finding Exclusion Criteria: * patients younger than the age approved for treatment with setmelanotide
Contact & Investigator
Metin Cetiner, PD Dr. med.
PRINCIPAL INVESTIGATOR
Universitätsmedizin Essen
Frequently Asked Questions
Who can join the NCT07674290 clinical trial?
This trial is open to participants of all sexes, studying Bardet Biedl Syndrome (BBS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07674290 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07674290 currently recruiting?
Yes, NCT07674290 is actively recruiting participants. Contact the research team at tom.huehne@uk-essen.de for enrollment information.
Where is the NCT07674290 trial being conducted?
This trial is being conducted at Essen, Germany.
Who is sponsoring the NCT07674290 clinical trial?
NCT07674290 is sponsored by Tom Hühne. The principal investigator is Metin Cetiner, PD Dr. med. at Universitätsmedizin Essen. The trial plans to enroll 200 participants.