A Study to Evaluate the Effect of Fasting Duration and Tirzepatide Withholding on the Amount of Food and Fluid in the Stomach in Participants With Type 2 Diabetes Mellitus and Participants With Overweight or Obesity Without Type 2 Diabetes Mellitus

What Was Tested

This registered phase 1 trial tested Tirzepatide.

The purpose of this study is to evaluate how fasting and stopping the use of tirzepatide affects the amount of food and drink that stays in the stomach after a meal.

Ultrasound will be used to check the stomach content after a test meal.

It had two arms (groups): Participants with Type 2 Diabetes (experimental) and Participants with Overweight or Obesity Without Type 2 Diabetes (experimental).

Participants will receive tirzepatide subcutaneously (SC).

Participants will receive tirzepatide SC.

The registry classes the interventions as drug.

Who Took Part

40 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Meet one of the following criteria:. Have type 2 diabetes. Have overweight with at least one health issue related to weight but without type 2 diabetes.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: have a condition that affects how their stomach empties; have had weight loss surgery; have type 1 diabetes.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

The Tirzepatide group and the comparison group ran side by side rather than switching.

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

It started in 2026-01-14 with completion listed for 2026-11.

It ran at 1 site in Singapore.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal (time frame: Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal)).

It also tracked 7 secondary outcomes, for example Percentage of Participants with Lack of Gastric Content Retention Post-Liquid Test Meal, Amount of Gastric Content Volume Post-Liquid Test Meal, Amount of Gastric Content Volume Post-Solid Test Meal, Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal After Discontinuation of Tirzepatide, Percentage of Participants with Grades 0, 1, and 2 from Antrum Grading Scale Post-Solid Test Meal and Percentage of Participants with Grades 0, 1, and 2 from Antrum Grading Scale Post-Liquid Test Meal.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Tirzepatide in 40 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.