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RecruitingPhase 2

Glucagon-Like Peptide-1 Receptor Agonist in ADPKD

Advancing ADPKD Treatment With GLP-1RA: A Study of Glucagon-Like Peptide-1 Receptor Agonists' Efficacy, Safety, and Mechanism

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a year of a GLP-1 medicine, approved for weight control, can slow kidney growth in adults with ADPKD, an inherited disease that causes kidney cysts. It is for adults who are overweight or obese. Researchers will also study belly fat, how kidneys use energy, and treatment safety.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–65.
  • Have ADPKD diagnosed using the study’s required rules.
  • Have a body mass index (BMI) of 27 or higher, a measure of weight compared with height.
  • Have an estimated kidney filtering rate (eGFR) of at least 30.
  • Have Mayo class C, D, or E, a kidney disease rating based on an ultrasound or MRI from the past 12 months.
  • Are not in, or planning to join, a formal weight-loss program, exercise program, or another study testing a treatment.
  • Can understand the study and agree to take part.

Who can't join

  • Have diabetes; use or plan to start tolvaptan; or have blood pressure with a top number over 160 or a bottom number over 100.
  • Were in the hospital or had major surgery in the past 3 months.
  • Are pregnant, breastfeeding, or unwilling to use adequate birth control.
  • Regularly use medicines that may affect weight, appetite, eating, or how the body uses energy; or have a diagnosed eating disorder, such as anorexia, bulimia, or binge eating disorder.
  • Had a weight change of more than 5% in the past 3 months, except weight loss after childbirth; or weigh 450 pounds or more.
  • Cannot safely have or complete an MRI, including because of severe fear of tight spaces, implants, devices, or body piercings that cannot be removed.
  • Have cancer or had cancer within the past 5 years; or have a personal or family history of medullary thyroid cancer, a thyroid lump, or multiple endocrine neoplasia type 2, a condition that causes tumors in hormone-making glands.
  • Have ever had pancreatitis, which is swelling of the pancreas.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CO