A Study of Dulaglutide in Healthy Participants

What Was Tested

The trial (phase 1) is built around Dulaglutide.

This study will evaluate how much of the study drug enters the body and how long it takes the body to get rid of it.

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

It had two arms (groups): Dulaglutide (Reference) (experimental) and Dulaglutide (Test) (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 27 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Overtly healthy as determined by medical history and physical examination at time of screening. Have a body mass index of greater than or equal to (≥) 23 kilograms per meter squared (kg/m²) inclusive.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: have known allergies to dulaglutide, glucagon-like peptide-1 (glp-1) related compounds, or any components of the formulation; have family history of medullary thyroid cancer (mtc) or a genetic condition that predisposes to mtc.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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

In the crossover set-up each of the participants took both Dulaglutide and the comparison in turn, acting as their own control.

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.

It started in 2017-12-07 with completion listed for 2018-06-06.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Dulaglutide in 27 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.