Study of Tirzepatide in Healthy Participants

What Was Tested

In this phase 1 trial, researchers set out to test Tirzepatide.

The purpose of this study is to look at how much tirzepatide gets into the bloodstream and how long the body takes to get rid of it.

This means that a radioactive tracer substance, C14, will be incorporated into the study drug to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine, feces and expired air.

It had 1 arm (groups): 14C Tirzepatide (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 6 actual participants took part.

It was open to men only aged from 30 years up to 55 years.

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

Examples of who could join: Overtly healthy males as determined by medical history, physical examination, and other screening procedures. Have a body mass index (BMI) between 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive at screening. Are willing to be available for the full duration of the study.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: have known allergies to tirzepatide or related compounds; have participated in any clinical trial involving a radiolabeled substance within the past 12 months.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Tirzepatide study: the participants and staff both knew the treatment.

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

It started in 2020-07-28 with completion listed for 2020-10-02.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 6 secondary outcomes, for example Total Number of Metabolites, Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable), PK: Maximum Concentration (Cmax) of Tirzepatide and PK: Maximum Concentration (Cmax) of Total Radioactivity.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Tirzepatide in 6 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 Tirzepatide compound page, all human trials.