NCT07803744

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
2mo left

Started Sep 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

September 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

September 11, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 1, 2026

Last Update Submit

September 21, 2026

Conditions

Diabetes Mellitus, Type 1OverweightObesity

Outcome Measures

Primary Outcomes (3)

  • Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) 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

  • PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen

    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

    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

    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

Study Arms (2)

Tirzepatide + Acetaminophen

EXPERIMENTAL

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

Drug: TirzepatideDrug: Acetaminophen

Placebo + Acetaminophen

PLACEBO COMPARATOR

Participants will receive placebo administered SC and acetaminophen administered orally.

Drug: AcetaminophenDrug: Placebo

Interventions

TirzepatideDRUG

Administered SC.

Also known as: LY3298176
Tirzepatide + Acetaminophen
AcetaminophenDRUG

Administered orally.

Placebo + AcetaminophenTirzepatide + Acetaminophen
PlaceboDRUG

Administered SC.

Placebo + Acetaminophen

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharmacology of Miami

Miami, Florida, 33172, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1OverweightObesity

Interventions

TirzepatideAcetaminophen

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide ReceptorsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Gastrointestinal HormoneReceptors, PeptideAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Central Study Contacts

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

CONTACT

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

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2026

First Posted

September 4, 2026

Study Start

September 11, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 23, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)