Recruiting
Phase 1

Tirzepatide

Sponsor:

Eli Lilly and Company

Code:

NCT07803744

Conditions

Diabetes Mellitus, Type 1

Overweight

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Acetaminophen

Placebo

Study Details

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Overweight

Obesity

Study ID

NCT07803744

Start date

Sep 11, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Tirzepatide + Acetaminophen

Participants will receive tirzepatide administered subcutaneously (SC) and acetaminophen administered orally.

placebo comparator: Placebo + Acetaminophen

Participants will receive placebo administered SC and acetaminophen administered orally.

Interventions

Tirzepatide

Administered SC.

Acetaminophen

Administered orally.

Placebo

Administered SC.

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Clinical Pharmacology of Miami

Recruiting

Miami, Florida, United States, 33172

Contacts

305-817-2900

Principal Investigator:

Angel Lamas

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.