GBGT

Active not recruitingPhase 1

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

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

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Perioperative / gastric aspiration risk, Type 2 diabetes

Key I/E criterion

•HbA1c ≥6.5%

Primary endpoint

•Percentage of Fasting Participants

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07313813

Org study ID27367

Secondary IDH9X-MC-GBGTEli Lilly and Company

Timeline

Milestones

Study start2025-12-29actual

Study first posted2026-01-02actual

Last update posted2026-04-16actual

Primary completion2026-08estimated (month precision)

Study completion2026-08estimated (month precision)

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Perioperative / gastric aspiration riskType 2 diabetes

Eligibility

Who can enroll

Minimum age21 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

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)

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other clinical outcomes

8 endpoints

Primary/protocol endpoint

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)

threshold achievement, improvement

Secondary/protocol endpoint

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)

threshold achievement, improvement

Secondary/protocol endpoint

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)

threshold achievement, improvement

Secondary/protocol endpoint

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)

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

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

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

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)

categorical status, descriptive

Secondary/protocol endpoint/low confidence

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)

threshold achievement, improvement

Secondary/protocol endpoint

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

threshold achievement, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.