Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
126 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for adults with a kidney condition called ADPKD who are overweight or obese. Participants will take a medication for one year to see if it can help slow kidney growth and improve other health factors.
Are You a Good Fit for This Trial?
Rules you outDiabetesMalignant neoplasmMedullary thyroid carcinomaPancreatitis
You may be able to join if
I am between 18 and 65 years old.
I have been diagnosed with ADPKD.
My body mass index is 27 or higher.
My kidney function is adequate.
I have a specific Mayo classification.
I am not currently in a weight loss program.
I can give informed consent.
You may not be able to join if
I have diabetes.
I have used or plan to use tolvaptan.
I have been hospitalized or had major surgery in the last 3 months.
I have high blood pressure that is not under control.
I am pregnant, breastfeeding, or cannot use birth control.
I regularly take medications that affect weight or metabolism.
I have a history of eating disorders.
I have gained or lost more than 5% of my weight in the last 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 m…
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.
Trial Locations
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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…
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
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