Tests tirzepatide to see if it slows kidney growth in polycystic kidney disease
Tests tirzepatide against placebo in adults with polycystic kidney disease and obesity.
Plain-language title generated from the registry record
Registry title: Glucagon-Like Peptide-1 Receptor Agonist in ADPKD
Key facts
- Where
- Aurora, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06582875, who can take part
Where in United States
- University of Colorado Anschutz Medical CampusAurora, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Colorado, Denver
- Trial code
- NCT06582875
- Record updated
- 6 May 2025
- Original description
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.Read full original descriptionShow less
Advancing ADPKD Treatment With GLP-1RA: A Study of Glucagon-Like Peptide-1 Receptor Agonists' Efficacy, Safety, and Mechanism
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.
Inclusion: 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: Regular use of prescription or over-the-counter medications that may affect weight, appetite, food intake, or energy metabolism; Inability to cooperate with or clinical contraindication for MRI including: severe claustrophobia, implants, devices, or non-removable body piercings; Prior history of pancreatitis; Diabetes mellitus; History of hospitalization or major surgery within the last 3 months; Uncontrolled hypertension (systolic blood pressure > 160 or diastolic blood pressure >100 mm Hg); History of clinically diagnosed eating disorder including: anorexia nervosa, bulimia, binge eating disorder; 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; Tolvaptan usage or plans to initiate tolvaptan; Pregnancy, lactation, or unwillingness to use adequate birth control; Weight change of >5% in the past 3 months for any reason except post-partum weight loss; Weight ≥450 lb.