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Completed Phase 1 Interventional

A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease

ClinicalTrials.gov ID: NCT05521191

Public ClinicalTrials.gov record NCT05521191. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 12:01 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose and an Open-Label Fixed-Dose Study in Patients With Autosomal Dominant Polycystic Kidney Disease to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RGLS8429

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT05521191
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Regulus Therapeutics Inc.
Industry
Enrollment
68 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 6, 2022 (Actual)
Primary completion
Jan 27, 2025 (Actual)
Completion
Mar 27, 2025 (Actual)
Last update posted
Jun 3, 2025

2022 – 2025

United States locations

U.S. sites
21
U.S. states
16
U.S. cities
20
Facility City State ZIP Site status
Centricity Research Phoenix Multispecialty Mesa Arizona 85206 —
Academic Medical Research Institute Los Angeles California 90022 —
Yale Nephrology Outpatient Clinic New Haven Connecticut 06510 —
Mayo Clinic - Florida Jacksonville Florida 32224 —
Elixia Orlando Florida 32806 —
Southeastern Clinical Research Institute, LLC Augusta Georgia 30904 —
CARE Institute Boise Idaho 83706 —
CARE Institute Chubbuck Idaho 83202 —
The Idaho Kidney Institute Idaho Falls Idaho 83404 —
University of Chicago Chicago Illinois 60617 —
Research by Design, LLC Chicago Illinois 60643 —
University of Iowa Iowa City Iowa 52242 —
University of Kansas Medical Center Jared Grantham Kidney Institute Kansas City Kansas 66160 —
Witchita Nephrology Group, PA Wichita Kansas 67214 —
University of Maryland School of Medicine, Nephrology Baltimore Maryland 21201 —
Tufts Medical Center Boston Massachusetts 02111 —
St. Clair Nephrology Research Roseville Michigan 48066 —
Mayo Clinic - Rochester Rochester Minnesota 55905 —
Northeast Clinical Research Center Bethlehem Pennsylvania 18017 —
University of Texas Southwestern Medical Center Dallas Texas 75390 —
Swedish Center for Comprehensive Care Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05521191, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 3, 2025 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05521191 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →