Type 2 Diabetes Mellitus (T2DM)Phase 1GBGTNCT07313813
A Study to Evaluate the Effect of Fasting Duration and Dulaglutide (LY2189265) Withholding on Gastric Retention in Participants With Type 2 Diabetes Mellitus
A Phase 1 study testing Dulaglutide in people with Type 2 Diabetes Mellitus (T2DM), run by Eli Lilly and Company at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Dulaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Dec 2025to 13 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Dulaglutide
- Keywords
- Point of Care Ultrasound (POCUS)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DulaglutideDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Dulaglutide (LY2189265)-Solid-Meal | Experimental | Administered subcutaneously (SC) Receives: Drug: Dulaglutide |
| Dulaglutide (LY2189265)-Liquid-Meal | Experimental | Administered SC Receives: Drug: Dulaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Fasting Participants with Lack of Gastric Content Retention Post-Solid Test Meal
Percentage of Fasting Participants with Lack of Gastric Content Retention Post-Solid Test Meal
Measured: Day 116 (at 6, 8, 12, 18 and 24 hours after baseline or Day 115 solid test meal)
Secondary outcomes (7)
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 Retention After Dulaglutide (LY2189265) Post-Liquid Test Meal
Measured: 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-Liquid Test Meal After Dulaglutide (LY2189265)
Measured: 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-Solid Test Meal After Dulaglutide (LY2189265)
Percentage of Fasting Participants with Lack of Gastric Content Volume Post-Solid Test Meal After Dulaglutide (LY2189265)
Measured: Day 116 (at 6, 8, 12, 18 and 24 hours after baseline or Day 115 solid test meal)
Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal After Discontinuation of Dulaglutide (LY2189265)
Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal After Discontinuation of Dulaglutide (LY2189265)
Measured: 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 Dulaglutide (LY2189265)
Percentage of Participants with Grades 0, 1, 2 from Antrum Grading Scale Post-Solid Test Meal After Dulaglutide (LY2189265)
Measured: 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-Liquid Test Meal After Dulaglutide (LY2189265)
Percentage of Participants with Grades 0, 1, 2 from Antrum Grading Scale Post-Liquid Test Meal After Dulaglutide (LY2189265)
Measured: 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-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 Discontinuation of Dulaglutide (LY2189265)
Measured: Baseline, through 8 days after discontinuation of dulaglutide at 6, 8, 12, 18 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start29 Dec 2025
- Primary completion13 Aug 2026
- Study completion13 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313813
- Sponsor's protocol ID
- 27367
- Other IDs
- H9X-MC-GBGT
- Acronym
- GBGT
- Status last verified
- Aug 2026
- First submitted
- 18 Dec 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07313813
- Acronym / sponsor ID
- GBGT / 27367
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Point of Care Ultrasound (POCUS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 13 Aug 2026 (actual)
- Study completion
- 13 Aug 2026 (actual)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dulaglutide (LY2189265)-Solid-Meal | Experimental | Drug: DulaglutideAdministered subcutaneously (SC) |
| Dulaglutide (LY2189265)-Liquid-Meal | Experimental | Drug: DulaglutideAdministered SC |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with Type 2 Diabetes Mellitus (T2DM) as determined by medical history and have:
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DulaglutideAdministered SC | Drug | Dulaglutide (LY2189265)-Liquid-Meal, Dulaglutide (LY2189265)-Solid-Meal |
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)
Percentage of Fasting Participants with Lack of Gastric Content Retention Post-Solid Test Meal
7 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 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-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 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 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-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-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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Lilly TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dulaglutide in people with Type 2 Diabetes Mellitus (T2DM), run by Eli Lilly and Company at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.