Using a medication to slow kidney growth in patients with a genetic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a glucagon-like peptide-1 receptor agonist, tirzepatide, in slowing kidney growth in adults with autosomal dominant polycystic kidney disease (ADPKD) who are overweight or obese. Participants will receive either the medication or a placebo for one year, with assessments of kidney size, abdominal fat, and metabolic changes through advanced imaging techniques and biological sample analysis. The study aims to provide an alternative to current treatments, which have limited adherence due to side effects.

Why it matters

Who can join: the full rules

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 it's running

• University of Colorado - Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting

Study contacts

• Study coordinator: Kristen Nowak, PhD, MPH
• Email: Kristen.Nowak@cuanschutz.edu
• Phone: 3037244842

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.