A Study of Tirzepatide at Different Injection Sites in Participants With Different Body Sizes

What Was Tested

This registered phase 1 trial tested 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 injected under the skin of the upper arm and thigh compared to the abdomen.

The study will be conducted in healthy males and females with different body sizes.

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

It had three arms (groups): Tirzepatide - Upper Arm (experimental), Tirzepatide - Thigh (experimental) and Tirzepatide - Abdomen (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 54 actual participants took part.

It was open to people of any sex aged from 18 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 18.5 and 45.0 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

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

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

Each person switched between Tirzepatide and the comparison at some point, usually with a gap in between.

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

It started in 2019-09-13 with completion listed for 2020-04-03.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): PK: Maximum Concentration (Cmax) of Tirzepatide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide in 54 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.