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NCT Number: NCT07313813

A Study to Evaluate the Effect of Fasting Duration and Dulaglutide (LY2189265) Withholding on Gastric Retention 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

21 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

  • 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)

Treatment and study plan

Dulaglutide

Drug

Administered SC

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

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 Dulaglutide on Retained Gastric Contents Using Gastric Ultrasound in Participants With Type 2 Diabetes Mellitus

Acronym: GBGT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 2, 2026
Registry last updated
Apr 16, 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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