Diabetes Mellitus, Type 1Phase 1NCT07803744
A Study of Tirzepatide (LY3298176) in Participants With Type 1 Diabetes Mellitus and Overweight or Obesity
A Phase 1 study testing Tirzepatide and Acetaminophen in people with Diabetes Mellitus, Type 1 and Overweight, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The main purpose of this study is to learn more how tirzepatide affects stomach emptying in participants with Type 1 Diabetes Mellitus (T1DM) and overweight or obesity. Participation in this study will last about 8 weeks, including screening and follow-up. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Overweight, Obesity
- What is being tested?
- Tirzepatide and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2026to Dec 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
- Have a diagnosis of type 1 diabetes mellitus (T1DM) and have been treated with insulin for at least 1 year prior to screening
- Have a body mass index (BMI) greater than or equal to 25.0 kilograms per square meter (kg/m2) at screening
- Are of stable weight, that is a self-reported change of 5 kg or less, for at least 90 days prior to screening
Who cannot join
- Participants who have a known clinically significant gastric emptying abnormality
- Have undergone weight loss surgery such as gastric bypass (bariatric) surgery or restrictive bariatric surgery
- Have known allergies or intolerance to acetaminophen, tirzepatide, or glucagon-like peptide-1 (GLP-1) receptor agonists
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
United States1 site, 1 recruiting
- Recruiting
Clinical Pharmacology of Miami
Miami, Florida, 33172
305-817-2900
Angel Lamas
About this study
Official title: A Phase 1, Investigator- and Participant- Blinded, Randomized, Placebo-Controlled, Single-Dose Study to Investigate the Impact of Tirzepatide on Gastric Emptying in Adult Participants With Type 1 Diabetes Mellitus and Overweight or Obesity
The main purpose of this study is to learn more how tirzepatide affects stomach emptying in participants with Type 1 Diabetes Mellitus (T1DM) and overweight or obesity.
Participation in this study will last about 8 weeks, including screening and follow-up.
- Conditions
- Diabetes Mellitus, Type 1, Overweight, Obesity
- Being tested
- Tirzepatide, Acetaminophen, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1, 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.
AcetaminophenDrug
Administered orally.
PlaceboDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide + Acetaminophen | Experimental | Participants will receive tirzepatide administered subcutaneously (SC) and acetaminophen administered orally. Receives: Drug: Tirzepatide; Drug: Acetaminophen |
| Placebo + Acetaminophen | Placebo comparator | Participants will receive placebo administered SC and acetaminophen administered orally. Receives: Drug: Acetaminophen; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Acetaminophen
Measured: Predose on Day 1 through 36 hours post dose
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC0-tlast) of Acetaminophen
Measured: Predose on Day 1 through 36 hours post dose
PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen
Measured: Predose on Day 1 through 36 hours post dose
Secondary outcomes (4)
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC0-∞) of Tirzepatide
Measured: Predose on Day 1 through Day 29
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC0-tlast) of Tirzepatide
Measured: Predose on Day 1 through Day 29
PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide
Measured: Predose on Day 1 through Day 29
PK: Time of Maximum Observed Drug Concentration (Tmax) of Tirzepatide
Measured: Predose on Day 1 through Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start11 Sep 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 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 1Studies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 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
- NCT07803744
- Sponsor's protocol ID
- 27861
- Other IDs
- I8F-MC-GPJI
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 23 Sep 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Investigator- and Participant- Blinded, Randomized, Placebo-Controlled, Single-Dose Study to Investigate the Impact of Tirzepatide on Gastric Emptying in Adult Participants With Type 1 Diabetes Mellitus and Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07803744
- Acronym / sponsor ID
- 27861
- Conditions
- Diabetes Mellitus, Type 1, Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Sep 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 main purpose of this study is to learn more how tirzepatide affects stomach emptying in participants with Type 1 Diabetes Mellitus (T1DM) and overweight or obesity.
Participation in this study will last about 8 weeks, including screening and follow-up.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide + Acetaminophen | Experimental | Drug: Tirzepatide, Drug: AcetaminophenParticipants will receive tirzepatide administered subcutaneously (SC) and acetaminophen administered orally. |
| Placebo + Acetaminophen | Placebo comparator | Drug: Acetaminophen, Drug: PlaceboParticipants will receive placebo administered SC and acetaminophen administered orally. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a diagnosis of type 1 diabetes mellitus (T1DM) and have been treated with insulin for at least 1 year prior to screening
- Have a body mass index (BMI) greater than or equal to 25.0 kilograms per square meter (kg/m2) at screening
- Are of stable weight, that is a self-reported change of 5 kg or less, for at least 90 days prior to screening
Key exclusion criteria (3 listed)
- Participants who have a known clinically significant gastric emptying abnormality
- Have undergone weight loss surgery such as gastric bypass (bariatric) surgery or restrictive bariatric surgery
- Have known allergies or intolerance to acetaminophen, tirzepatide, or glucagon-like peptide-1 (GLP-1) receptor agonists
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 | Tirzepatide + Acetaminophen |
| AcetaminophenAdministered orally. | Drug | Placebo + Acetaminophen, Tirzepatide + Acetaminophen |
| PlaceboAdministered SC. | Drug | Placebo + Acetaminophen |
Primary outcome
Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Acetaminophen
Time frame: Predose on Day 1 through 36 hours post dose
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC0-tlast) of Acetaminophen
Time frame: Predose on Day 1 through 36 hours post dose
PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen
Time frame: Predose on Day 1 through 36 hours post dose
4 secondary outcomes
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC0-∞) of Tirzepatide
Time frame: Predose on Day 1 through Day 29
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC0-tlast) of Tirzepatide
Time frame: Predose on Day 1 through Day 29
PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide
Time frame: Predose on Day 1 through Day 29
PK: Time of Maximum Observed Drug Concentration (Tmax) of Tirzepatide
Time frame: Predose on Day 1 through Day 29
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 23 Sep 2026.
- 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.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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 and Acetaminophen in people with Diabetes Mellitus, Type 1 and Overweight, run by Eli Lilly and Company at 1 site in United States.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 Sep 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 United States. 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. Some participants in this study may receive a placebo. 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?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Acetaminophen (time frame: Predose on Day 1 through 36 hours post dose). The study lists 3 primary outcomes in all. 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 23 Sep 2026.