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NCT05521191 · ClinicalTrials.gov registry record · Phase 1
A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease
A Phase 1 study, sponsored by Regulus Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT05521191: Completed Phase 1 study, sponsored by Regulus Therapeutics.
NCT05521191 is a Phase 1 study that has completed, run by Regulus Therapeutics. The registered enrollment target is 68 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05521191, a Phase 1 study, has completed, sponsored by Regulus Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
Primary Objectives * To assess the safety and tolerability of RGLS8429 * To assess the impact of RGLS8429 on ADPKD biomarkers Secondary Objectives * To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV) * To characterize the pharmacokinetic (PK) properties of RGLS8429 * To assess the impact of RGLS8429 on renal function
Primary Outcome
Incidence of adverse events over time
Interventions
- DRUG Placebo
- DRUG RGLS8429
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2022-10-06 |
| Est. Completion | 2025-03-27 |
| Phase | Phase 1 |
What the finished NCT05521191 record still lists
NCT05521191 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05521191 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05521191 about?
NCT05521191 is a clinical study titled "A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease". Primary Objectives * To assess the safety and tolerability of RGLS8429 * To assess the impact of RGLS8429 on ADPKD biomarkers Secondary Objectives * To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV) * To characterize the pharmacokinetic (PK) properties of RGLS8429 * ...
What is the current status of trial NCT05521191?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2022-10-06. Estimated completion is 2025-03-27.
What interventions are being tested in trial NCT05521191?
The interventions under investigation include: Placebo (DRUG), RGLS8429 (DRUG).
Who is sponsoring clinical trial NCT05521191?
This trial is sponsored by Regulus Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05521191's enrollment target sits among peer trials
68 776th of 2000 higher than 1,219 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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