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Active, not recruiting

NCT Number: NCT07299084

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology

Singapore, 138623

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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)

  6. 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)]

  7. 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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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