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

NCT05521191 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-06-03

No results posted yet for this 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

Conditions

  • Autosomal Dominant Polycystic Kidney Disease
  • ADPKD
  • Polycystic Kidney, Autosomal Dominant

Interventions

DRUG

RGLS8429

Solution for subcutaneous injection

DRUG

Placebo

Solution for subcutaneous injection

Sponsors & Collaborators

  • Regulus Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Rekha Garg, MD · Regulus Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-06
Primary Completion
2025-01-27
Completion
2025-03-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05521191 on ClinicalTrials.gov