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HomeTrials › NCT06582875

Obesity & weight · Phase 2 · Recruiting now

Glucagon-Like Peptide-1 Receptor Agonist in ADPKD

NCT06582875 · Sponsor: University of Colorado, Denver

What this trial means for you

This study is recruiting now at 1 US site. It's studying Tirzepatide for autosomal dominant polycystic kidney, obesity.

Who can joinAll sexes, 18 Years – 65 Years
Healthy volunteersNo — diagnosis required
What you'd takeTirzepatide
Study length~4.3 years overall
Planned participants126
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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

Study sites by state

Colorado

  • University of Colorado - Anschutz Medical Campus — Aurora · Recruiting now

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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