Glucagon-Like Peptide-1 Receptor Agonist in ADPKD

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06582875
Phase
PHASE2
Status
Recruiting
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Conditions

  • Autosomal Dominant Polycystic Kidney
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Titrated to dose of 5 mg once weekly subcutaneous
  • Placebo — OTHER
    Titrated to dose of 5 mg once weekly subcutaneous

Study Details

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.

Key Dates

Start date
Mar 6, 2025
Status verified
May 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    To minimize the risk of gastrointestinal adverse events, we will use a standard dose-escalation regimen for tirzepatide (placebo-matched), starting at 2.5 mg once weekly (OW) at randomization. After 4 weeks of treatment at 2.5 mg, the dose will be escalated to 5 mg OW, which will be maintained for another 4 weeks and then continued as the target dose for 10 months until the end of treatment. As with other nutrient stimulating hormone (NuSH) therapies, dose reductions and extensions of dose-escalation intervals will be permitted if participants experience unacceptable adverse events. The minimum tolerated dose required for continued study participation is 2.5 mg/week. All dose changes will be documented in the study records.
  • Placebo Comparator: Placebo
    To minimize the risk of gastrointestinal adverse events, we will use a standard dose-escalation regimen for tirzepatide (placebo-matched), starting at 2.5 mg once weekly (OW) at randomization. After 4 weeks of treatment at 2.5 mg, the dose will be escalated to 5 mg OW, which will be maintained for another 4 weeks and then continued as the target dose for 10 months until the end of treatment. As with other nutrient stimulating hormone (NuSH) therapies, dose reductions and extensions of dose-escalation intervals will be permitted if participants experience unacceptable adverse events. The minimum tolerated dose required for continued study participation is 2.5 mg/week. All dose changes will be documented in the study records.

Primary Outcome Measure

Change in height-Adjusted Total kidney volume [ Time Frame: Baseline, 12-months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado - Anschutz Medical CampusAuroraColorado80045
Kristen Nowak, PhD, MPH
[email protected]
303-724-4842
Kristen Nowak, PhD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Colorado - Anschutz Medical Campus· Aurora, CO

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