Glucagon-Like Peptide-1 Receptor Agonist in ADPKD

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

Qualifiers

18-65 years of age

ADPKD diagnosis based on the modified Pei-Ravine criteria

Body-mass index of ≥27 kg/m²

Estimated glomerular filtration rate ≥ 30 mL/min/1.73m²

Disqualifiers

Diabetes mellitus

Tolvaptan usage or plans to initiate tolvaptan

History of hospitalization or major surgery within the last 3 months

Uncontrolled hypertension (systolic blood pressure > 160 or diastolic blood pressure >100 mm Hg)

Trial design

Treatments tested in this trial

  • Tirzepatide
  • Placebo

Treatment groups

126 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Colorado, Denver

Lead sponsor

Washington University School of Medicine

Collaborator

Mayo Clinic

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator