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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPJE | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Type 2 Diabetes | Experimental | Participants will receive tirzepatide subcutaneously (SC) |
|
| Participants with Overweight or Obesity Without Type 2 Diabetes | Experimental | Participants will receive tirzepatide SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
|
| Measure | Description | 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) |
| Measure | Description | 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) |
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Inclusion Criteria:
Meet one of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lilly Centre for Clinical Pharmacology | Singapore | 138623 | Singapore |
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| Label | URL |
|---|---|
| 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 | View source |
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| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
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