A Study of the Effect of Dulaglutide on How Body Handles Digoxin in Healthy Participants

What Was Tested

This registered phase 1 trial tested Dulaglutide.

The purpose of this study is to study how the body processes digoxin and the effect of dulaglutide on how digoxin is processed by the body.

Information about any side effects that may occur will also be collected.

This study is for research purposes only and is not intended to treat any medical condition.

It had 1 arm (groups): Digoxin + Dulaglutide (experimental).

The registry classes the interventions as biological and drug.

Who Took Part

24 actual participants took part.

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

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

Examples of who could join: Are overtly healthy males or females, as determined by medical history and physical examination. Condom with spermicidal agent. Male participant sterilization. True abstinence (which is in line with the participant's usual lifestyle choice; withdrawal or calendar methods are not considered acceptable). Have a body mass index (BMI) of 18.5 to 32.0 kilogram per square meter (kg/m\^2), inclusive, at screening.

The full record lists 13 inclusion and 23 exclusion criteria; among the exclusions: have known allergies to glucagon like peptide-1 (glp-1)-related compounds including dulaglutide (ly2189265) or to digoxin, related compounds or any components of either formulation; have family history of medullary thyroid cancer (mtc) or a genetic condition that predisposes to mtc; regularly use known drugs of abuse and/or show positive findings on urinary drug screening.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Dulaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2011-09 with completion listed for 2011-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Dulaglutide in 24 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.