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Active not recruitingPhase 1

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

Enrollment

40

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

Primary endpoint

Lack of Gastric Content Retention Post-Solid Test Meal

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 IDNCT07299084
Org study ID27358
Secondary IDI8F-MC-GPJEEli Lilly and Company

Timeline

Milestones

Study first posted2025-12-23actual
Study start2026-01-14actual
Last update posted2026-05-19actual
Primary completion2026-11estimated (month precision)
Study completion2026-11estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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

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.

Coverage by outcome category

Other clinical outcomes
5
Other (unclassified)
3

Other clinical outcomes

5 endpoints
Primary/protocol endpoint

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)

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

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)

threshold achievement, improvement

Secondary/protocol endpoint

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

threshold achievement, improvement

Secondary/protocol endpoint

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)

categorical status, descriptive

Secondary/protocol endpoint/low confidence

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

categorical status, descriptive

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

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)

descriptive

Secondary/protocol endpoint/low confidence

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)

descriptive

Secondary/protocol endpoint/low confidence

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)]

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.