A Study to Evaluate the Effect of Fasting Duration and Dulaglutide (LY2189265) Withholding on Gas… (NCT07313813) | Clinical Trial Compass
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
Singapore20 participantsStarted 2025-12-29
Plain-language summary
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.
Who can participate
Age range21 Years – 70 Years
SexALL
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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 r…
What they're measuring
1
Percentage of Fasting Participants with Lack of Gastric Content Retention Post-Solid Test Meal
Timeframe: Day 116 (at 6, 8, 12, 18 and 24 hours after baseline or Day 115 solid test meal)