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NCT05194124 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway
A Phase 3 study, sponsored by Rhythm Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 19
- Enrollment target
NCT05194124: Completed Phase 3 study, sponsored by Rhythm Pharmaceuticals.
NCT05194124 is a Phase 3 study that has completed, run by Rhythm Pharmaceuticals. The registered enrollment target is 19 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05194124, a Phase 3 study, has completed, sponsored by Rhythm Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 19 participants
- Enrollment target
Study Summary
A trial to compare the weekly and daily formulations of setmelanotide in participants with genetic defects in the melanocortin-4 receptor pathway.
Primary Outcome
Maximum drug concentration determined directly from individual concentration-time data.
Interventions
- DRUG Setmelanotide 2 mg
- DRUG Setmelanotide 2.5 mg
- DRUG Setmelanotide 3 mg
- DRUG Setmelanotide 20 mg
- DRUG Setmelanotide 25 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-12-21 |
| Est. Completion | 2023-10-19 |
| Phase | Phase 3 |
What the finished NCT05194124 record still lists
NCT05194124 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Setmelanotide 2 mg is the first listed.
NCT05194124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05194124 about?
NCT05194124 is a clinical study titled "Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway". A trial to compare the weekly and daily formulations of setmelanotide in participants with genetic defects in the melanocortin-4 receptor pathway.
What is the current status of trial NCT05194124?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2021-12-21. Estimated completion is 2023-10-19.
What interventions are being tested in trial NCT05194124?
The interventions under investigation include: Setmelanotide 2 mg (DRUG), Setmelanotide 2.5 mg (DRUG), Setmelanotide 3 mg (DRUG), Setmelanotide 20 mg (DRUG), Setmelanotide 25 mg (DRUG).
Who is sponsoring clinical trial NCT05194124?
This trial is sponsored by Rhythm Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05194124's enrollment target sits among peer trials
19 1969th of 2000 higher than 31 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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