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New treatment option for Autosomal Dominant Polycystic Kidney
Official title Glucagon-Like Peptide-1 Receptor Agonist in ADPKD
ClinicalTrials.gov ID: NCT06582875
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for autosomal dominant polycystic kidney.
Also referred to as Zepbound.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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 treatment study
- Ability to provide informed consent
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.