NCT06582875RecruitingPhase 2
Glucagon-Like Peptide-1 Receptor Agonist in ADPKD
Advancing ADPKD Treatment With GLP-1RA: A Study of Glucagon-Like Peptide-1 Receptor Agonists' Efficacy, Safety, and Mechanism
Source: ClinicalTrials.gov · Last updated 6 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 26 Aug 2024
- Start date
- 6 Mar 2025
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Polycystic kidney disease, Obesity
- NCT number
- NCT06582875
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 126
- From 6 Mar 2025 to the primary completion date, 30 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
Related publications
- Cardiovascular-Kidney-Metabolic Syndrome in Autosomal Dominant Polycystic Kidney Disease.J Am Soc Nephrol · 2026 · PMID 42789922
- Emerging Therapies in Autosomal Dominant Polycystic Kidney Disease.Kidney360 · 2026 · PMID 41385299
- The Need for Novel Therapeutic Directions in Autosomal Dominant Polycystic Kidney Disease Patient Care.Clin J Am Soc Nephrol · 2026 · PMID 41348481
This page is information, not medical advice. Discuss any trial with your doctor.