Glucagon-Like Peptide-1 Receptor Agonist in ADPKD

Launched by UNIVERSITY OF COLORADO, DENVER · Aug 30, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring whether a medication called a glucagon-like peptide 1 receptor agonist can help slow the growth of kidneys in adults with a condition known as autosomal dominant polycystic kidney disease (ADPKD), particularly those who are overweight or obese. This medication is already approved for helping people manage their weight. Over two years, participants will receive this treatment, and researchers will use advanced imaging techniques to look at how it affects kidney and abdominal fat. They will also collect blood and urine samples to understand the biological changes that might occur from the treatment while closely monitoring safety.

To be eligible for this trial, participants need to be between 18 and 65 years old, diagnosed with ADPKD, and have a body mass index (BMI) of 27 or higher. They should also have a certain kidney function level and not be involved in any other weight loss programs or clinical studies. Throughout the study, participants can expect regular check-ups and tests to ensure their safety and track the progress of the treatment. It’s important to note that certain health conditions and medications may exclude someone from participating, so each person’s medical history will be carefully reviewed.

Gender

ALL

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