A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide

What Was Tested

This registered phase 1 trial tested Tirzepatide.

The purpose of this study is to learn more about how tirzepatide affects stomach emptying in overweight/very overweight participants.

Participants include those without diabetes and those with type 2 diabetes.

The study will last about 13 weeks for each participant, including screening.

It had 1 arm (groups): Tirzepatide + Acetaminophen (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 36 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²), inclusive at screening. For nondiabetic subjects: as determined by medical history, physical examination, and safety assessments at screening. Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: have undergone gastric bypass or bariatric surgery; have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening; have any lifetime history of a suicide attempt.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Tirzepatide 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 2020-09-15 with completion listed for 2021-01-07.

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 Observed Drug Concentration (Cmax) of Acetaminophen.

It also tracked 5 secondary outcomes, for example Hemoglobin A1c (HbA1c) Data by Diabetic Status, PK: Cmax of Acetaminophen at Steady State Non-diabetic and PK: Cmax of Acetaminophen at Steady State For T2DM.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Tirzepatide in 36 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.