Glucagon-Like Peptide-1 Receptor Agonist in ADPKD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-65 years of age
ADPKD diagnosis based on the modified Pei-Ravine criteria
Body-mass index of ≥27 kg/m²
Estimated glomerular filtration rate ≥ 30 mL/min/1.73m²
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Tirzepatide
DrugTitrated to dose of 5 mg once weekly subcutaneous
Placebo
Other interventionTitrated to dose of 5 mg once weekly subcutaneous
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: TirzepatideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in height-Adjusted Total kidney volume
To assess kidney growth,height-adjusted total kidney volume will be measured by magnetic resonance imaging at baseline and 12 months to determine annual percent change.
Time frame
Baseline, 12-monthsSecondary outcomes
1
Change in body weight
Change in body weight over the 12-month period will be measured using a calibrated digital scale.
Time frame
Baseline, 12-months2
Change in abdominal adiposity
Abdominal adiposity (subcutaneous, visceral, and total) will be assessed by magnetic resonance imaging.
Time frame
Baseline, 12-months3
Change in adiponectin (circulating)
Venous blood samples will be analyzed for this mechanistic biomarker
Time frame
Baseline, 6-months, 12-months4
Change in leptin (circulating)
Venous blood samples will be analyzed for this mechanistic biomarker
Time frame
Baseline, 6-months, 12-monthsOther outcomes
1
Change in renal blood flow
Phase contrast magentic resonance imaging will be used to measure change in renal blood flow
Time frame
Baseline, 12-months2
Safety (adverse events)
Number of participants with treatment-related adverse events in each group as evaluated by the DSMB
Time frame
12 months3
Adherence
Compliance will be assessed by cross-checking the following sources and comparing these to the expected use: (1) drug accountability information; (2) counting returned trial product, visual inspection of pens; and (3) discussion with participants.
Time frame
12 months4
Tolerability (dropout due to adverse events)
Subject dropout due to treatment-emergent adverse events
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
Washington University School of Medicine
Collaborator
Mayo Clinic
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov