Glucagon-Like Peptide-1 Receptor Agonist in ADPKD

What Was Tested

In this phase 2 trial, researchers set out to test Tirzepatide.

It had two arms (groups): Tirzepatide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

However, GLP-1RAs have not yet been evaluated as a novel therapy for slowing ADPKD progression in patients with overweight/obesity.

As a novel therapeutic in ADPKD, GLP-1RAs could transform the treatment landscape for patients.

Who Took Part

The registry lists 126 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 18-65 years of age. ADPKD diagnosis based on the modified Pei-Ravine criteria. Body-mass index of ≥27 kg/m\^2. 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.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: 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).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-03-06 with completion listed for 2029-06-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 15 secondary outcomes, for example Change in body weight, Change in abdominal adiposity, Change in adiponectin (circulating), Change in leptin (circulating), Change in interleukin-6 (circulating) and Change in tumor necrosis-factor-alpha (circulating).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 126 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.