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NCT04348175 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment
A Phase 1 study, sponsored by Rhythm Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT04348175: Completed Phase 1 study, sponsored by Rhythm Pharmaceuticals.
NCT04348175 is a Phase 1 study that has completed, run by Rhythm Pharmaceuticals. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04348175, a Phase 1 study, has completed, sponsored by Rhythm Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This is a Phase 1, multi-center, open-label, single-dose study designed to assess the effect of renal impairment on the PK of setmelanotide. A total of approximately 32 subjects (approximately 8 subjects in each renal impairment group and 8 healthy subjects with normal renal function) are planned to be enrolled across 4 centers in the United States. At screening, subjects will be assigned to a study group according to eGFR. Cohort A - Mild Renal Impairment Cohort B - Moderate Renal Impairment Cohort C - Severe Renal Impairment Cohort D - Normal Renal Function (control)
Primary Outcome
The primary objective of this study is to evaluate the PK of a single dose of Setmelanotide administered SC in subjects with varying degrees of renal impairment and that of healthy matched control subjects.
Interventions
- DRUG Setmelanotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-07-09 |
| Est. Completion | 2021-04-17 |
| Phase | Phase 1 |
What the finished NCT04348175 record still lists
NCT04348175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which Setmelanotide is the first listed.
NCT04348175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04348175 about?
NCT04348175 is a clinical study titled "A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment". This is a Phase 1, multi-center, open-label, single-dose study designed to assess the effect of renal impairment on the PK of setmelanotide. A total of approximately 32 subjects (approximately 8 subjects in each renal impairment group and 8 healthy subjects with normal renal function) are planned to...
What is the current status of trial NCT04348175?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2020-07-09. Estimated completion is 2021-04-17.
What interventions are being tested in trial NCT04348175?
The interventions under investigation include: Setmelanotide (DRUG).
Who is sponsoring clinical trial NCT04348175?
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 NCT04348175's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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