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NCT05046132 · ClinicalTrials.gov registry record · Phase 4
Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants
A Phase 4 study of Healthy, sponsored by Rhythm Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 77
- Enrollment target
- 1
- Study location
NCT05046132: Completed Phase 4 study of Healthy, sponsored by Rhythm Pharmaceuticals.
NCT05046132 is a Phase 4 study of Healthy that has completed, run by Rhythm Pharmaceuticals. The registered enrollment target is 77 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05046132, a Phase 4 study of Healthy, has completed, sponsored by Rhythm Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 77 participants
- Enrollment target
- 1
- Study location
Study Summary
This was a double-blind, randomized, placebo- and positive-controlled, parallel group, 3-arm study that assessed the potential for therapeutic and supratherapeutic concentrations of setmelanotide to affect the QTc corrected by the Fredericia method (QTcF) interval.
Primary Outcome
Continuous 12-lead digital electrocardiogram (ECG) recording was performed on Baseline and Day 10. ECG analysts were blinded to the treatment, timepoint and participant. QT interval was corrected for heart rate using QTcF. CHFB in QTcF was calculated at each timepoint.
Conditions Studied
Interventions
- DRUG Oral Placebo
- DRUG Moxifloxacin
- DRUG Setmelanotide
- DRUG SC Placebo
Study Locations (1)
California
- Parexel Early Phase Clinical Unit (Los Angeles) - Glendale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2021-08-05 |
| Est. Completion | 2022-04-07 |
| Phase | Phase 4 |
What the finished NCT05046132 record still lists
NCT05046132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 4 interventions - of which Oral Placebo is the first listed.
NCT05046132 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05046132 about?
NCT05046132 is a clinical study titled "Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants". This was a double-blind, randomized, placebo- and positive-controlled, parallel group, 3-arm study that assessed the potential for therapeutic and supratherapeutic concentrations of setmelanotide to affect the QTc corrected by the Fredericia method (QTcF) interval.
What is the current status of trial NCT05046132?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 77 participants. The study started on 2021-08-05. Estimated completion is 2022-04-07.
What conditions does trial NCT05046132 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT05046132?
The interventions under investigation include: Oral Placebo (DRUG), Moxifloxacin (DRUG), Setmelanotide (DRUG), SC Placebo (DRUG).
Who is sponsoring clinical trial NCT05046132?
This trial is sponsored by Rhythm Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05046132 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05046132's enrollment target sits among peer trials
77 291st of 1090 higher than 797 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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