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NCT04536688 · ClinicalTrials.gov registry record · Phase 1

A Study of RGLS4326 in Patients With Autosomal Dominant Polycystic Kidney Disease

A Phase 1 study, sponsored by Regulus Therapeutics.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target

NCT04536688: Completed Phase 1 study, sponsored by Regulus Therapeutics.

NCT04536688 is a Phase 1 study that has completed, run by Regulus Therapeutics. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04536688, a Phase 1 study, has completed, sponsored by Regulus Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target

Study Summary

Primary Objective • To assess the dose response relationship between RGLS4326 and ADPKD biomarkers Secondary Objectives * To characterize the pharmacokinetic (PK) properties of RGLS4326 in plasma and urine * To assess the safety and tolerability of RGLS4326

Primary Outcome

Changes in polycystin-1 (PC-1) and polycystin-2 (PC-2) protein levels in urinary exosomes from baseline to Day 44

Interventions

  • DRUG RGLS4326

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2020-10-13
Est. Completion 2021-11-12
Phase Phase 1
Regulus Therapeutics

3 total trials

What the finished NCT04536688 record still lists

NCT04536688 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 1 intervention - of which RGLS4326 is the first listed.

NCT04536688 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04536688 about?

NCT04536688 is a clinical study titled "A Study of RGLS4326 in Patients With Autosomal Dominant Polycystic Kidney Disease". Primary Objective • To assess the dose response relationship between RGLS4326 and ADPKD biomarkers Secondary Objectives * To characterize the pharmacokinetic (PK) properties of RGLS4326 in plasma and urine * To assess the safety and tolerability of RGLS4326

What is the current status of trial NCT04536688?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2020-10-13. Estimated completion is 2021-11-12.

What interventions are being tested in trial NCT04536688?

The interventions under investigation include: RGLS4326 (DRUG).

Who is sponsoring clinical trial NCT04536688?

This trial is sponsored by Regulus Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04536688's enrollment target sits among peer trials

19 1716th of 2000 higher than 281 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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Source: ClinicalTrials.gov NCT04536688, the US trial registry maintained by the National Library of Medicine. NCT04536688 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.