Advancing ADPKD Treatment With GLP-1RA: A Study of Glucagon-Like Peptide-1 Receptor Agonists' Efficacy, Safety, and Mechanism

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. The trial will also evaluate changes in total body weight, adipose volume and function, insulin resistance, kidney oxidative metabolism, and inflammation, and carefully monitor safety and tolerability. As a novel therapeutic in ADPKD, GLP-1RAs could transform the treatment landscape for patients. The trial will also evaluate changes in total body weight, adipose volume and function, insulin resistance, kidney oxidative metabolism, and inflammation, and carefully monitor safety and tolerability. As a novel therapeutic in ADPKD, GLP-1RAs could transform the treatment landscape for patients.

CT.gov Identifier
NCT06582875
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Washington University School of Medicine
Collaborator
National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases, Mayo Clinic, (Other Hospital/Academic/Medical Center)
Study Contact Information
N/A
Recruiting
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Study Details

Diseases
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study Drug
Tirzepatide
Genes
PKD1
GANAB
Study Dates
Mar 2025 - Jun 2029
Sex
Female & Male
Age
18 - 65 Years
Inclusion and Exclusion Criteria
Inclusion Criteria:
  • 18-65 years of age
  • ADPKD diagnosis based on the modified Pei-Ravine criteria
  • Body-mass index of ≥27 kg/m^2
  • Estimated glomerular filtration rate ≥ 30 mL/min/1.73m^2
  • Mayo Classification of C, D, or E, calculated from a previous kidney ultrasound or MRI performed within the last 12 months
  • Not currently participating in or planning to participate in any formal weight loss or physical activity program, or another interventional study
  • Ability to provide informed consent
Exclusion Criteria:
  • 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)
  • Pregnancy, lactation, or unwillingness to use adequate birth control
  • Regular use of prescription or over-the-counter medications that may affect weight, appetite, food intake, or energy metabolism
  • History of clinically diagnosed eating disorder including: anorexia nervosa, bulimia, binge eating disorder
  • Weight change of >5% in the past 3 months for any reason except post-partum weight loss
  • Inability to cooperate with or clinical contraindication for MRI including: severe claustrophobia, implants, devices, or non-removable body piercings
  • Presence or personal history of malignant neoplasm within 5 years prior to the day of screening
  • Personal or family history of medullary thyroid carcinoma, thyroid nodule, or multiple endocrine neoplasia type 2
  • Prior history of pancreatitis
  • Weight ≥450 lb

Protocol Summary

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.

The trial will also evaluate changes in total body weight, adipose volume and function, insulin resistance, kidney oxidative metabolism, and inflammation, and carefully monitor safety and tolerability. As a novel therapeutic in ADPKD, GLP-1RAs could transform the treatment landscape for patients.

The trial will also evaluate changes in total body weight, adipose volume and function, insulin resistance, kidney oxidative metabolism, and inflammation, and carefully monitor safety and tolerability. As a novel therapeutic in ADPKD, GLP-1RAs could transform the treatment landscape for patients.

Study Locations

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