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Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity
Plain-language guide to NCT07674290: phase 4 interventional trial of Setmelanotide, 200 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07674290
- Phase
- phase 4
- Status
- recruiting participants
- Start
- 2023-01-01
- Completion (planned or actual)
- 2030-12-31
- Participants
- 200 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Bardet Biedl Syndrome (BBS); Bardet Biedl Syndrome; Bardet-Biedl Syndrome (BBS); Alstrom Syndrome
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Setmelanotide.
Setmelanotide, an MC4R agonist, is approved in Europe for selected genetic obesity disorders and reimbursed in Germany for eligible patients.
It had 1 arm (groups): MC4R Therapy (experimental).
Patients receiving approved MC4 receptor agonists according to licensed indications and routine clinical practice.
The registry classes the interventions as drug.
More on the Plan
The MC4R signaling pathway is a key regulator of appetite and energy balance.
Genetic defects affecting this pathway lead to severe obesity syndromes including Bardet-Biedl syndrome and other rare monogenic obesity disorders.
This study seeks to characterize treatment outcomes in everyday clinical practice, including changes in body weight, BMI, hyperphagia, metabolic parameters, quality of life, treatment adherence, and adverse events.
Patients receiving approved MC4R agonist therapy will be followed prospectively.
Who Took Part
The registry lists 200 planned participants were the target.
It was open to people of any sex.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Clinical phenotype corresponding to Bardet-Biedl Syndrome. Genetic testing with notable finding.
The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: patients younger than the age approved for treatment with setmelanotide.
How the Study Was Run
The set-up was single-group and open-label.
Being open-label, the Setmelanotide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2023-01-01 with completion listed for 2030-12-31.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Percent change in BMI z-score (time frame: Baseline to 12/24/36/48/60/72 months). Impact on lipid profile (time frame: Baseline to 12/24/36/48/60/72 months). Change in Hepatic Fat Attenuation (time frame: Baseline to 12/24/36/48/60/72 months).
It also tracked 5 secondary outcomes, for example Life quality, Safety and Tolerability, Cognitive changes, Functional brain connectivity and Changes on hypothalamic-pituitary-gonadal axis.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Setmelanotide in 200 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Setmelanotide compound page, all human trials.
Our Notes on the Compound
Setmelanotide: An FDA-approved melanocortin-4 receptor agonist for rare genetic obesity (POMC, PCSK1, LEPR deficiency and Bardet-Biedl syndrome).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.