A Study to Evaluate the Effect of Fasting Duration and Dulaglutide (LY2189265) Withholding on Gastric Retention in Participants With Type 2 Diabetes Mellitus (GBGT)

April 15, 2026 updated by: Eli Lilly and Company

A Study to Evaluate the Effect of Fasting Duration and Temporary Withholding of Dulaglutide on Retained Gastric Contents Using Gastric Ultrasound in Participants With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate how fasting and stopping the use of Dulaglutide (LY2189265) affect the amount of food and drink that stays in your stomach after a meal.

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

The study can last approximately 28 weeks.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

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:

  • Participants with Type 2 Diabetes Mellitus (T2DM) as determined by medical history and have:

    • a diagnosis of T2DM for at least 6 months
    • T2DM controlled with diet and exercise alone or are on a stable dose of metformin, with or without 1 additional oral antihyperglycemic medication, a dipeptidyl peptidase-4 (DPP-4) inhibitor or sodium glucose transporter-2 inhibitor (SGLT-2i), for at least 1 month, and
    • a hemoglobin A1c value at screening of greater than or equal to 6.5% and less than or equal to 10.0%

Exclusion Criteria:

  • Have a known clinically significant gastric emptying abnormality (for example, gastroparesis or gastric outlet obstruction), have undergone weight loss surgery such as gastric bypass (bariatric) surgery or restrictive bariatric surgery (for example, Lap-Band®), or have had endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months (for example, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal bypass sleeve)
  • Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study drug, or of interfering with the interpretation of data
  • Participants who have clinical laboratory test results, blood pressure, and pulse rate that are outside the normal reference range for the population
  • Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, melanocortin 4 receptor deficiency or Prader-Willi Syndrome)

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: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dulaglutide (LY2189265)-Solid-Meal
Administered subcutaneously (SC)
Drug: Dulaglutide
Administered SC
Experimental: Dulaglutide (LY2189265)-Liquid-Meal
Administered SC
Drug: Dulaglutide
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Fasting Participants with Lack of Gastric Content Retention Post-Solid Test Meal
Time Frame: Day 116 (at 6, 8, 12, 18 and 24 hours after baseline or Day 115 solid test meal)
Percentage of Fasting Participants with Lack of Gastric Content Retention Post-Solid Test Meal
Day 116 (at 6, 8, 12, 18 and 24 hours after baseline or Day 115 solid test meal)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Fasting Participants with Lack of Gastric Content Retention After Dulaglutide (LY2189265) Post-Liquid Test Meal
Time Frame: Day 123 (at 6, 8, 12, 18 and 24 hours after Day 122 liquid test meal)
Percentage of Fasting Participants with Lack of Gastric Content Retention After Dulaglutide (LY2189265) Post-Liquid Test Meal
Day 123 (at 6, 8, 12, 18 and 24 hours after Day 122 liquid test meal)
Percentage of Fasting Participants with Lack of Gastric Content Volume Post-Liquid Test Meal After Dulaglutide (LY2189265)
Time Frame: Day 123 (at 6, 8, 12, 18 and 24 hours after Day 122 liquid test meal)
Percentage of Fasting Participants with Lack of Gastric Content Volume Post-Liquid Test Meal After Dulaglutide (LY2189265)
Day 123 (at 6, 8, 12, 18 and 24 hours after Day 122 liquid test meal)
Percentage of Fasting Participants with Lack of Gastric Content Volume Post-Solid Test Meal After Dulaglutide (LY2189265)
Time Frame: Day 116 (at 6, 8, 12, 18 and 24 hours after baseline or Day 115 solid test meal)
Percentage of Fasting Participants with Lack of Gastric Content Volume Post-Solid Test Meal After Dulaglutide (LY2189265)
Day 116 (at 6, 8, 12, 18 and 24 hours after baseline or Day 115 solid test meal)
Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal After Discontinuation of Dulaglutide (LY2189265)
Time Frame: Baseline, through 8 days after discontinuation of dulaglutide at 6, 8, 12, 18 and 24 hours
Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal After Discontinuation of Dulaglutide (LY2189265)
Baseline, through 8 days after discontinuation of dulaglutide at 6, 8, 12, 18 and 24 hours
Percentage of Participants with Grades 0, 1, 2 from Antrum Grading Scale Post-Solid Test Meal After Dulaglutide (LY2189265)
Time Frame: Day 116 (at 6, 8, 12, 18 and 24 hours after baseline or Day 115 solid test meal)
Percentage of Participants with Grades 0, 1, 2 from Antrum Grading Scale Post-Solid Test Meal After Dulaglutide (LY2189265)
Day 116 (at 6, 8, 12, 18 and 24 hours after baseline or Day 115 solid test meal)
Percentage of Participants with Grades 0, 1, 2 from Antrum Grading Scale Post-Liquid Test Meal After Dulaglutide (LY2189265)
Time Frame: Day 123 (at 6, 8, 12, 18 and 24 hours after Day 122 liquid test meal)
Percentage of Participants with Grades 0, 1, 2 from Antrum Grading Scale Post-Liquid Test Meal After Dulaglutide (LY2189265)
Day 123 (at 6, 8, 12, 18 and 24 hours after Day 122 liquid test meal)
Percentage of Participants with Grades 0, 1, 2 from Antrum Grading Scale Post-Solid Test Meal After Discontinuation of Dulaglutide (LY2189265)
Time Frame: Baseline, through 8 days after discontinuation of dulaglutide at 6, 8, 12, 18 and 24 hours
Percentage of Participants with Grades 0, 1, 2 from Antrum Grading Scale Post-Solid Test Meal After Discontinuation of Dulaglutide (LY2189265)
Baseline, through 8 days after discontinuation of dulaglutide 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 - 5 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)

December 29, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

January 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27367
  • H9X-MC-GBGT (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.

Clinical Trials on Type 2 Diabetes Mellitus (T2DM)

Clinical Trials on Dulaglutide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe