Glucagon-Like Peptide-1 Receptor Agonist in ADPKD

NCT06582875 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-05-06

No results posted yet for this study

Summary

The proposed clinical trial aims to assess if a year of treatment with a glucagon-like peptide 1 receptor agonist, a medication approved for weight management that also improves the body's response to glucose and insulin, can slow kidney growth in adults with autosomal dominant polycystic kidney disease who are overweight or obese. The study will also evaluate changes in abdominal fat and kidney metabolism using cutting-edge images techniques. Blood and urine samples will provide further insight into biological changes that may be linked to the benefits of the intervention, while ensuring careful monitoring of safety and tolerability.

Conditions

  • Autosomal Dominant Polycystic Kidney
  • Obesity

Interventions

DRUG

Tirzepatide

Titrated to dose of 5 mg once weekly subcutaneous

OTHER

Placebo

Titrated to dose of 5 mg once weekly subcutaneous

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER
  • Mayo Clinic

    collaborator OTHER
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • University of Colorado, Denver

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-03-06
Primary Completion
2029-06-30
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT06582875 on ClinicalTrials.gov