Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT06582875

Glucagon-Like Peptide-1 Receptor Agonist in ADPKD

Led by University of Colorado, Denver · Updated on 2025-05-06

126

Participants Needed

1

Research Sites

225 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

W

Washington University School of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Glucagon-Like Peptide-1 Receptor Agonist in ADPKD

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 to 65 years of age
  • Diagnosis of autosomal dominant polycystic kidney disease (ADPKD) based on the modified Pei-Ravine criteria
  • Body-mass index of 27 kg/m2 or higher
  • Estimated glomerular filtration rate of at least 30 mL/min/1.73m2
  • Mayo Classification of C, D, or E from kidney ultrasound or MRI within the last 12 months
  • Not currently in or planning to join any formal weight loss, physical activity program, or another interventional study
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of diabetes mellitus
  • Current use or planned start of tolvaptan treatment
  • Hospitalization or major surgery within the last 3 months
  • Uncontrolled hypertension with systolic blood pressure over 160 or diastolic over 100 mm Hg
  • Pregnancy, breastfeeding, or unwillingness to use effective birth control
  • Regular use of medications affecting weight, appetite, food intake, or energy metabolism
  • History of eating disorders such as anorexia nervosa, bulimia, or binge eating disorder
  • Weight change over 5% in past 3 months except postpartum weight loss
  • Inability to cooperate with or contraindication for MRI, including severe claustrophobia, implants, devices, or non-removable piercings
  • History or presence of cancer within 5 years before screening
  • Personal or family history of medullary thyroid carcinoma, thyroid nodules, or multiple endocrine neoplasia type 2
  • Prior pancreatitis
  • Weight 450 pounds or more

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

K

Kristen Nowak, PhD, MPH

CONTACT

D

Diana George

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Glucagon-Like Peptide-1 Receptor Agonist in ADPKD | DecenTrialz