NCT06582875 · University of Colorado, Denver
Glucagon-Like Peptide-1 Receptor Agonist in ADPKD
What this study 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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Aurora, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2025 · Source of record for eligibility and locations