NCT06582875 Glucagon-Like Peptide-1 Receptor Agonist in ADPKD
| NCT ID | NCT06582875 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Colorado, Denver |
| Condition | Autosomal Dominant Polycystic Kidney |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2025-03-06 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 126 participants in total. It began in 2025-03-06 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06582875 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Autosomal Dominant Polycystic Kidney. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06582875 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06582875 currently recruiting?
Yes, NCT06582875 is actively recruiting participants. Contact the research team at Kristen.Nowak@cuanschutz.edu for enrollment information.
Where is the NCT06582875 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06582875 clinical trial?
NCT06582875 is sponsored by University of Colorado, Denver. The trial plans to enroll 126 participants.
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