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

May 18, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 138623
        • Lilly Centre for Clinical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with Type 2 Diabetes
Participants will receive tirzepatide subcutaneously (SC)
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Experimental: Participants with Overweight or Obesity Without Type 2 Diabetes
Participants will receive tirzepatide SC
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal)

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Lack of Gastric Content Retention Post-Liquid Test Meal
Time Frame: Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 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
Time Frame: Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 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
Time Frame: Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 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
Time Frame: Baseline through 8 days after discontinuation of tirzepatide at 6, 8, 12,18 and 24 hours
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
Time Frame: Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 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
Time Frame: Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 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
Time Frame: Baseline through 8 days after discontinuation of tirzepatide at 6, 8, 12,18 and 24 hours
Baseline through 8 days after discontinuation of tirzepatide at 6, 8, 12,18 and 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27358
  • I8F-MC-GPJE (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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