A Study of Tirzepatide (LY3298176) in Participants With Type 1 Diabetes Mellitus and Overweight or Obesity

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07803744

Enrollment

Registered

2026-09-04

Start date

2026-09-01

Completion date

2026-12-01

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1, Obesity, Overweight

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.

Interventions

DRUGTirzepatide

Administered SC.

DRUGAcetaminophen

Administered orally.

DRUGPlacebo

Administered SC.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen	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	Predose on Day 1 through 36 hours post dose
Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Acetaminophen	Predose on Day 1 through 36 hours post dose

Secondary

Measure	Time frame
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC0-tlast) of Tirzepatide	Predose on Day 1 through Day 29
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC0-∞) of Tirzepatide	Predose on Day 1 through Day 29
PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide	Predose on Day 1 through Day 29
PK: Time of Maximum Observed Drug Concentration (Tmax) of Tirzepatide	Predose on Day 1 through Day 29

Countries

United States

Contacts

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

LillyTrials@Lilly.com1-317-615-4559

CONTACTPhysicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

STUDY_DIRECTORCall 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)

Eli Lilly and Company

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026