A Study of Tirzepatide (LY3298176) in Participants With Impaired Kidney Function

What Was Tested

This registered phase 1 trial tested Tirzepatide.

The purpose of this study is to assess how fast tirzepatide gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.

It had five arms (groups): Tirzepatide - Control (experimental), Tirzepatide - Mild Renal Impairment (experimental), Tirzepatide - Moderate Renal Impairment (experimental), Tirzepatide - Severe Renal Impairment (experimental) and Tirzepatide - End Stage Renal Disease (ESRD) (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 45 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Are between the body mass index (BMI) of 19.0 and 40.0 kilograms per meter squared (kg/m²), inclusive, at screening. Participants with Renal Impairment or ESRD:. Participants with Type 2 Diabetes Mellitus (T2DM) and Renal Impairment or ESRD:. Have T2DM controlled with diet or exercise alone or stable on metformin for at least 8 weeks.

The full record lists 9 inclusion and 12 exclusion criteria; among the exclusions: all participants:; women of childbearing potential; have known allergies to tirzepatide or related compounds.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Tirzepatide study: the participants and staff both knew the treatment.

It started in 2018-03-30 with completion listed for 2019-08-19.

It ran at 4 sites in United States (4).

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): PK: Maximum Concentration of Tirzepatide (time frame: Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose). PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC[0-inf]) (time frame: Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide in 45 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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