A Single Dose Study of LY2189265 in Subjects With Varying Degrees of Hepatic (Liver) Impairment

What Was Tested

The trial (phase 1) is built around Dulaglutide.

It had four arms (groups): Normal hepatic function (experimental), Mild hepatic impairment (experimental), Moderate hepatic impairment (experimental) and Severe hepatic impairment (experimental).

LY2189265: A single, subcutaneous (SC) 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function.

LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A).

LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 26 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: Women must be of non-child-bearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) or menopause. Women who have had cessation of menses for at least 2 years are permitted to take hormone replacement therapy. Have a body mass index (BMI) between 19.0 and 40.0 kilograms per meters squared (kg/m\^2), inclusive, at screening. Have venous access sufficient to allow blood sampling. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.

The full record lists 19 inclusion and 38 exclusion criteria; among the exclusions: have known allergies to ly2189265 or related compounds; have previously completed or withdrawn from this study or any other study investigating ly2189265; have a current, functioning organ transplant.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Being open-label, the Dulaglutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2010-11 with completion listed for 2011-11.

It ran at 2 sites in Germany (1) and Hungary (1).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Dulaglutide in 26 people.

Its size is small, so on its own it can only give an early look.

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

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