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

A Study to Evaluate the Effect of Fasting Duration and Temporary Withholding of Tirzepatide on Retained Gastric Contents Using Gastric Ultrasound in Participants With Type 2 Diabetes Mellitus and Participants With Overweight or Obesity Without Type 2 Diabetes Mellitus

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07299084

Enrollment

Registered

2025-12-23

Start date

2026-01-14

Completion date

2026-11-01

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Obesity, Overweight

Keywords

Point of Care Ultrasound (POCUS)

Brief summary

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.

Interventions

DRUGTirzepatide

Administered SC

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Meet one of the following criteria: * Have type 2 diabetes * Have obesity * Have overweight with at least one health issue related to weight but without type 2 diabetes

Exclusion criteria

* Have a condition that affects how their stomach empties * Have had weight loss surgery * Have type 1 diabetes * Have any major medical conditions or histories that could interfere with the study

Design outcomes

Primary

Measure	Time frame
Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal	Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal)

Secondary

Measure	Time frame
Percentage of Participants with Lack of Gastric Content Retention Post-Liquid Test Meal	Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 liquid test meal)
Amount of Gastric Content Volume Post-Liquid Test Meal	Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 liquid test meal)
Amount of Gastric Content Volume Post-Solid Test Meal	Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal)
Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal After Discontinuation of Tirzepatide	Baseline through 8 days after discontinuation of tirzepatide at 6, 8, 12,18 and 24 hours
Percentage of Participants with Grades 0, 1, and 2 from Antrum Grading Scale Post-Solid Test Meal	Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal)
Percentage of Participants with Grades 0, 1, and 2 from Antrum Grading Scale Post-Liquid Test Meal	Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 liquid test meal)]
Percentage of Participants with Grades 0, 1, and 2 from Antrum Grading Scale After Discontinuation of Tirzepatide	Baseline through 8 days after discontinuation of tirzepatide at 6, 8, 12,18 and 24 hours

Countries

Singapore

Contacts

STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026