Glucagon-Like Peptide-1 Receptor Agonist in ADPKD
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: kidney, other_emerging
- Who it enrolls
- age 18 Years to 65 Years; excludes diabetes; no BMI minimum stated; conditions: Autosomal Dominant Polycystic Kidney; Obesity
- Interventions
- Tirzepatide; Placebo
- Conditions
- Autosomal Dominant Polycystic Kidney; Obesity
- Phase and size
- Phase 2 · 126 participants
- Dates
- Start 2025-03-06
Primary completion 2029-06-30 - Sponsor
- University of Colorado, Denver (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Change in height-Adjusted Total kidney volumeBaseline, 12-months
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.