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A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
Plain-language guide to NCT05536804: phase 2 randomized trial of Tirzepatide, 134 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05536804
- Phase
- phase 2
- Status
- completed
- Start
- 2023-02-08
- Completion (planned or actual)
- 2026-07-06
- Participants
- 134 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Overweight; Obesity; Chronic Kidney Disease; Type 2 Diabetes; T2D
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Tirzepatide.
The researchers are doing this study to learn more about how tirzepatide may help fight chronic kidney disease in people with obesity with or without type 2 diabetes (T2D).
The study will last about 56 weeks and include up to 12 visits.
It had two arms (groups): Tirzepatide (experimental) and Placebo (placebo comparator).
Tirzepatide administered subcutaneously (SC).
Placebo administered SC.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 134 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have a Body Mass Index (BMI) ≥27 kilogram/square meter (kg/m²) at screening. Diagnosed with chronic kidney disease (CKD). Have been diagnosed at least 180 days prior to screening.
The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: have a self-reported change in body weight \>5 kilogram (kg) within 90 days prior to screening; have a prior or planned surgical treatment for obesity; have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 180 days.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.
Those kept unaware of assignments: participant and investigator.
It started in 2023-02-08 with completion listed for 2026-07-06.
It ran at 27 sites in United States (10), Mexico (6), Canada (5), Austria (3), Netherlands (2) and Denmark (1).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Percent Change from Baseline in Renal Sinus Fat Content (MRI) (time frame: Baseline, Week 52).
It also tracked 8 secondary outcomes, for example Percent Change from Baseline in Body Weight, Percent Change from Baseline in Renal Fat Content (MRI Proton Density Fat Fraction), Percent Change from Baseline in Renal Blood Flow (Phase-Contrast MRI), Change from Baseline in Apparent Diffusion Coefficient (ADC) MRI, Change from Baseline in Glomerular Filtration Rate (GFR) Iohexol Clearance in Milliliter/Minute/Square Meter (ml/min/m²) and Change from Baseline in Estimated Glomerular Filtration Rate (eGFR).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Tirzepatide in 134 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Tirzepatide compound page, all human trials.
Our Notes on the Compound
Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.