GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide

The Impact of Tirzepatide on Gastric Emptying (GE) in Overweight/Obese Non-diabetic Subjects and in Overweight/Obese Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI 27-45

Primary endpoints

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

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04407234

Org study ID17376

Secondary IDI8F-MC-GPHUEli Lilly and Company

Timeline

Milestones

Study first posted2020-05-29actual

Study start2020-09-15actual

Primary completion2021-01-07actual

Study completion2021-01-07actual

Last update posted2024-01-08actual

Results first posted2024-01-08actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

•Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²), inclusive at screening

•For nondiabetic subjects: as determined by medical history, physical examination, and safety assessments at screening

•For participants with a confirmed type 2 diabetes diagnosis: The condition must be managed either by diet and exercise alone or on a stable dose of metformin for the past 3 months

•Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

Key Exclusion Criteria

•Have undergone gastric bypass or bariatric surgery

•Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening

•For participants with a confirmed type 2 diabetes diagnosis: Have experienced more than 1 episode of severe low blood sugar that require emergency treatment, hospitalization or third parties to administer rescue treatment, in the past 6 months

•Have any lifetime history of a suicide attempt

•Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study

•Unwilling to comply with smoking and alcohol restrictions during the study

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

2 endpoints

Secondary/registry result

Hemoglobin A1c (HbA1c) Data by Diabetic Status

Time frame:Predose on Day 29 and follow-up (Day 64)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Non-DiabeticDay 29 ± 1	5.37	—
Day 64 ± 1 (Follow-Up)	5.29	—
T2DMDay 29 ± 1	7.27	—
Day 64 ± 1 (Follow-Up)	6.87	—

Secondary/protocol endpoint

Hemoglobin A1c (HbA1c) Data by Diabetic Status

Time frame:Predose on Day 29 and follow-up (Day 64)

descriptive

LOINC 4548-4

Safety / tolerability / PK

12 endpoints

Primary/registry result

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen

Time frame:Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramshours per milliliter (ngh/mL)	95% CI
Reference:160 mg Acetaminophen (Day -1)	49384	43635 – 55890
Test: 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2)	43523	38456 – 49257
Test: 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37)	57049	50171 – 64869

Ratio of geometric least squares mean0.88190% CI0.803 – 0.967Wilcoxon signed rank test

Ratio of geometric least squares mean1.1690% CI1.05 – 1.28Wilcoxon signed rank test

Primary/registry result

PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen

Time frame:Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanograms per milliliter (ng/mL)	95% CI
Reference:160 mg Acetaminophen (Day -1)	11925	10566 – 13460
Test: 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2)	5314	4708 – 5998
Test: 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37	8099	7111 – 9225

Ratio of geometric least squares mean0.44690% CI0.390 – 0.509Wilcoxon signed rank test

Ratio of geometric least squares mean0.67990% CI0.589 – 0.783Wilcoxon signed rank test

Primary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen

Time frame:Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

concentration, descriptive

Primary/protocol endpoint

PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen

Time frame:Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

Cmax

concentration, descriptive

Secondary/registry result

PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For Non-diabetic

Time frame:Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_least_squares_mean), nanogramshours per milliliter (ngh/mL)	95% CI
Reference (Non-diabetic):160 mg Acetaminophen (Day -1)	44350	37276 – 52766
Test (Non-diabetic): 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2)	39389	33107 – 46864
Test (Non-diabetic): 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37)	54735	45695 – 65563

Ratio of geometricleast squares mean0.88890% CI0.778 – 1.01

Ratio of geometricleast squares mean1.2390% CI1.07 – 1.42

Secondary/registry result

PK: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For T2DM

Time frame:Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_least_squares_mean), nanogramshours per milliliter (ngh/mL)	95% CI
Reference (T2DM):160 mg Acetaminophen (Day -1)	54989	46219 – 65424
Test (T2DM): 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2)	48090	40420 – 57215
Test (T2DM): 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37)	59440	49623 – 71199

Ratio of geometricleast squares mean0.87590% CI0.766 – 0.999

Ratio of geometricleast squares mean1.0890% CI0.938 – 1.25

Secondary/registry result

PK: Cmax of Acetaminophen at Steady State Non-diabetic

Time frame:Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_least_squares_mean), nanograms per milliliter (ng/mL)	95% CI
Reference (Non-diabetic):160 mg Acetaminophen (Day -1)	10255	8680 – 12115
Test (Non-diabetic): 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2)	4646	3932 – 5489
Test (Non-diabetic): 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37)	8245	6891 – 9866

Ratio of geometricleast squares mean0.45390% CI0.376 – 0.545

Ratio of geometricleast squares mean0.80490% CI0.660 – 0.979

Secondary/registry result

PK: Cmax of Acetaminophen at Steady State For T2DM

Time frame:Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_least_squares_mean), nanograms per milliliter (ng/mL)	95% CI
Reference (T2DM):160 mg Acetaminophen (Day -1)	13868	11738 – 16385
Test (T2DM): 5 mg Tirzepatide + 160 mg Acetaminophen (Day 2)	6078	5144 – 7181
Test (T2DM): 15 mg Tirzepatide + 160 mg Acetaminophen (Day 37)	7954	6648 – 9517

Ratio of geometricleast squares mean0.43890% CI0.364 – 0.527

Ratio of geometricleast squares mean0.57490% CI0.471 – 0.698

Secondary/protocol endpoint

PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For Non-diabetic

Time frame:Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

PK: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For T2DM

Time frame:Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

concentration, descriptive

Secondary/protocol endpoint

PK: Cmax of Acetaminophen at Steady State Non-diabetic

Time frame:Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

Cmax

concentration, descriptive

Secondary/protocol endpoint

PK: Cmax of Acetaminophen at Steady State For T2DM

Time frame:Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.