DRUG
Dulaglutide
Administered SC
A Study to Evaluate the Effect of Fasting Duration and Dulaglutide (LY2189265) Withholding on Gastric Retention in Participants With Type 2 Diabetes Mellitus
Status
Active, not recruiting
Phase
Phase 1
Enrollment
20
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jan 2, 2026
Study start
Dec 29, 2025
Primary completion
Aug 2026
Study completion
Aug 2026
Results posted
Not reported
Registry updated
Apr 16, 2026
Outcomes
What the study measures.
Primary outcomes
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
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
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)
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)
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)
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)
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)
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)
Eligibility
Who can take part.
- Minimum age
- 21 Years
- Maximum age
- 70 Years
- Sex
- ALL
- Healthy volunteers
- No
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)
Study locations
1 registered sites.
Singapore. Showing up to 24 locations stored in the fast local snapshot.
Lilly Centre for Clinical Pharmacology
Singapore, Singapore
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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More studies on Dulaglutide.
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Put the record in context.
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