Diabetes Mellitus, Type 2Phase 1NCT07299084
A Study to Evaluate the Effect of Fasting Duration and Tirzepatide Withholding on the Amount of Food and Fluid in the Stomach in Participants With Type 2 Diabetes Mellitus and Participants With Overweight or Obesity Without Type 2 Diabetes Mellitus
A Phase 1 study testing Tirzepatide in people with Diabetes Mellitus, Type 2 and Overweight, 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 tirzepatide affects the amount of food and drink that stays in the stomach after a meal. Ultrasound will be used to check the stomach content after a test meal. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Overweight, Obesity
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 14 Jan 2026to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet one of the following criteria:
- Have type 2 diabetes
- Have obesity
- Have overweight with at least one health issue related to weight but without type 2 diabetes
Who cannot join
- Have a condition that affects how their stomach empties
- Have had weight loss surgery
- Have type 1 diabetes
- Have any major medical conditions or histories that could interfere with the study
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 Tirzepatide on Retained Gastric Contents Using Gastric Ultrasound in Participants With Type 2 Diabetes Mellitus and Participants With Overweight or Obesity Without Type 2 Diabetes Mellitus
The purpose of this study is to evaluate how fasting and stopping the use of tirzepatide affects the amount of food and drink that stays in the stomach after a meal. Ultrasound will be used to check the stomach content after a test meal.
- Conditions
- Diabetes Mellitus, Type 2, Overweight, Obesity
- Being tested
- Tirzepatide
- Keywords
- Point of Care Ultrasound (POCUS)
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Participants with Type 2 Diabetes | Experimental | Participants will receive tirzepatide subcutaneously (SC) Receives: Drug: Tirzepatide |
| Participants with Overweight or Obesity Without Type 2 Diabetes | Experimental | Participants will receive tirzepatide SC Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal
Measured: Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal)
Secondary outcomes (7)
Percentage of Participants with Lack of Gastric Content Retention Post-Liquid Test Meal
Measured: Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 liquid test meal)
Amount of Gastric Content Volume Post-Liquid Test Meal
Measured: Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 liquid test meal)
Amount of Gastric Content Volume Post-Solid Test Meal
Measured: Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal)
Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal After Discontinuation of Tirzepatide
Measured: Baseline through 8 days after discontinuation of tirzepatide at 6, 8, 12,18 and 24 hours
Percentage of Participants with Grades 0, 1, and 2 from Antrum Grading Scale Post-Solid Test Meal
Measured: Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal)
Percentage of Participants with Grades 0, 1, and 2 from Antrum Grading Scale Post-Liquid Test Meal
Measured: Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 liquid test meal)]
Percentage of Participants with Grades 0, 1, and 2 from Antrum Grading Scale After Discontinuation of Tirzepatide
Measured: Baseline through 8 days after discontinuation of tirzepatide 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 posted23 Dec 2025
- Study start14 Jan 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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 - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299084
- Sponsor's protocol ID
- 27358
- Other IDs
- I8F-MC-GPJE
- Status last verified
- May 2026
- First submitted
- 10 Dec 2025
- Last updated
- 19 May 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 19 May 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 Tirzepatide on Retained Gastric Contents Using Gastric Ultrasound in Participants With Type 2 Diabetes Mellitus and Participants With Overweight or Obesity Without Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07299084
- Acronym / sponsor ID
- 27358
- Conditions
- Diabetes Mellitus, Type 2, Overweight, Obesity
- Keywords
- Point of Care Ultrasound (POCUS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 23 Dec 2025 (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 tirzepatide affects the amount of food and drink that stays in the stomach after a meal. Ultrasound will be used to check the stomach content after a test meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Type 2 Diabetes | Experimental | Drug: TirzepatideParticipants will receive tirzepatide subcutaneously (SC) |
| Participants with Overweight or Obesity Without Type 2 Diabetes | Experimental | Drug: TirzepatideParticipants will receive tirzepatide SC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet one of the following criteria:
Key exclusion criteria (4 listed)
- Have a condition that affects how their stomach empties
- Have had weight loss surgery
- Have type 1 diabetes
- Have any major medical conditions or histories that could interfere with the study
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 |
|---|---|---|
| TirzepatideAlso: LY3298176Administered SC | Drug | Participants with Overweight or Obesity Without Type 2 Diabetes, Participants with Type 2 Diabetes |
Primary outcome
Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal
Time frame: Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal)
7 secondary outcomes
Percentage of Participants with Lack of Gastric Content Retention Post-Liquid Test Meal
Time frame: Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 liquid test meal)
Amount of Gastric Content Volume Post-Liquid Test Meal
Time frame: Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 liquid test meal)
Amount of Gastric Content Volume Post-Solid Test Meal
Time frame: Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal)
Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal After Discontinuation of Tirzepatide
Time frame: Baseline through 8 days after discontinuation of tirzepatide at 6, 8, 12,18 and 24 hours
Percentage of Participants with Grades 0, 1, and 2 from Antrum Grading Scale Post-Solid Test Meal
Time frame: Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal)
Percentage of Participants with Grades 0, 1, and 2 from Antrum Grading Scale Post-Liquid Test Meal
Time frame: Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 liquid test meal)]
Percentage of Participants with Grades 0, 1, and 2 from Antrum Grading Scale After Discontinuation of Tirzepatide
Time frame: Baseline through 8 days after discontinuation of tirzepatide at 6, 8, 12,18 and 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- A Study to Evaluate the Effect of Fasting Duration and Tirzepatide Withholding on the Amount of Food and Fluid in the Stomach in Participants With Type 2 Diabetes Mellitus and Participants With Overweight or Obesity Without Type 2 Diabetes MellitusLink 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 - 8 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 Tirzepatide in people with Diabetes Mellitus, Type 2 and Overweight, 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: under way, not looking for participants, as of the sponsor's last update on 19 May 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?
This study is still under way. Results are not available in the source record yet.
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 Participants with Lack of Gastric Content Retention Post-Solid Test Meal (time frame: Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 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 19 May 2026.