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A Study to Evaluate the Effect of Fasting Duration and Dulaglutide (LY2189265) Withholding on Gastric Retention in Participants With Type 2 Diabetes Mellitus
Plain-language guide to NCT07313813: phase 1 randomized trial of Dulaglutide, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07313813
- Phase
- phase 1
- Status
- completed
- Start
- 2025-12-29
- Completion (planned or actual)
- 2026-08-13
- Participants
- 20 (actual)
- Design
- randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Type 2 Diabetes Mellitus (T2DM)
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Dulaglutide.
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.
It had two arms (groups): Dulaglutide (LY2189265)-Solid-Meal (experimental) and Dulaglutide (LY2189265)-Liquid-Meal (experimental).
Administered subcutaneously (SC).
Administered SC.
The registry classes the interventions as drug.
Who Took Part
20 actual participants took part.
It was open to people of any sex aged from 21 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Participants with Type 2 Diabetes Mellitus (T2DM) as determined by medical history and have:. A diagnosis of T2DM for at least 6 months.
The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: participants who have clinical laboratory test results, blood pressure, and pulse rate that are outside the normal reference range for the population.
How the Study Was Run
The set-up was randomized, sequential and open-label.
The participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.
Nothing was hidden in this open-label Dulaglutide study: the participants and staff both knew the treatment.
It started in 2025-12-29 with completion listed for 2026-08-13.
It ran at 1 site in Singapore.
Its stated primary purpose is basic science.
What Was Measured
Primary outcome: 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)).
It also tracked 7 secondary outcomes, for example 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), 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), Percentage of Participants with Grades 0, 1, 2 from Antrum Grading Scale Post-Solid Test Meal After Dulaglutide (LY2189265) and Percentage of Participants with Grades 0, 1, 2 from Antrum Grading Scale Post-Liquid Test Meal After Dulaglutide (LY2189265).
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Dulaglutide in 20 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Dulaglutide compound page, all human trials.
Our Notes on the Compound
Dulaglutide: A once-weekly GLP-1 receptor agonist (two GLP-1 analog chains joined to an antibody Fc fragment), sold as Trulicity.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.