A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants

What Was Tested

The trial (phase 1) is built around Tirzepatide.

The purpose of this study is to compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via an autoinjector versus a conventional prefilled syringe.

The tolerability of tirzepatide will also be evaluated and information about any adverse effects experienced will be collected.

Screening is required within 28 days prior to the start of the study.

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

The registry classes the interventions as device and drug.

Who Took Part

47 actual participants took part.

It was open to people of any sex aged from 21 years up to 70 years.

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

Examples of who could join: Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures. Are between the body mass index (BMI) of 18.0 and 32.0 kilograms per meter squared (kg/m²), inclusive, at screening. Are agreeable to receiving study treatment by injections under the skin.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: have known allergies to tirzepatide or related compounds; have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2; have a prior history of malignant disease(s) in the past 5 years prior to screening.

How the Study Was Run

Design: randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

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

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

It started in 2019-08-19 with completion listed for 2019-12-16.

It ran at 1 site in Singapore.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide (time frame: Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide in 47 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.