Recruiting
Phase 2

GLP-1 Agonist

Sponsor:

University of Colorado, Denver

Code:

NCT06582875

Conditions

Autosomal Dominant Polycystic Kidney

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Placebo

Study Details

Brief summary:

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.

Conditions

Autosomal Dominant Polycystic Kidney

Obesity

Study ID

NCT06582875

Start date

Mar 6, 2025

Status verified date

May, 2025

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Tirzepatide

Titrated to dose of 5 mg once weekly subcutaneous

Placebo

Titrated to dose of 5 mg once weekly subcutaneous

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kristen Nowak, PhD, MPH

3037244842Kristen.Nowak@cuanschutz.edu

Diana George

303-724-1684Diana.George@cuanschutz.edu

Locations

University of Colorado - Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Kristen Nowak, PhD, MPH

303-724-4842Kristen.Nowak@cuanschutz.edu

Principal Investigator:

Kristen Nowak, PhD, MPH

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 6, 2025

Last verified

May, 2025

Keywords

  • GLP1RA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-05-06.