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CompletedPhase 1Results posted

A Study of Tirzepatide at Different Injection Sites in Participants With Different Body Sizes

Effect of Injection Site on the Relative Bioavailability of a Single Dose of Tirzepatide in Subjects With Low and High Body Mass Indices

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

Enrollment

54

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

BMI 18.5-45Healthy volunteers

Primary endpoints

AUC of TirzepatidePK: Maximum Concentration (Cmax) of Tirzepatide

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 IDNCT04050670
Org study ID17224
Secondary IDI8F-MC-GPHIEli Lilly and Company

Timeline

Milestones

Study first posted2019-08-08actual
Study start2019-09-13actual
Primary completion2020-04-03actual
Study completion2020-04-03actual
Results first posted2023-03-24actual
Last update posted2023-05-06actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
Are between the body mass index (BMI) of 18.5 and 45.0 kilograms per meter squared (kg/m²), inclusive, at screening
Are agreeable to receiving study treatment by injections under the skin

Exclusion criteria

Have known allergies to tirzepatide or related compounds
Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors
Have a prior history of malignant disease(s) in the past 5 years prior to screening
Smoke more than the equivalent of 10 cigarettes per day
Is a known user of drugs of abuse

Endpoints (4)

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.

Safety / tolerability / PK

4 endpoints
Primary/registry result

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞])

Time frame:Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), Hour * nanogram per milliliter (h*ng/mL)95% CI
Tirzepatide - Abdomen112000
Tirzepatide - Upper Arm111000
Tirzepatide - Thigh106000
Ratio of geometric least squares mean0.95390% CI0.9350.970Linear mixed effects model
Ratio of geometric least squares mean0.99090% CI0.9721.01Linear mixed effects model
Primary/registry result

PK: Maximum Concentration (Cmax) of Tirzepatide

Time frame:Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose

Cmax

concentration, descriptive

Posted result

GroupValue (geometric_mean), Nanogram per Millilitre (ng/mL)95% CI
Tirzepatide - Abdomen603
Tirzepatide - Upper Arm556
Tirzepatide - Thigh520
Ratio of geometric least squares mean0.86290% CI0.8180.909Linear mixed effects model
Ratio of geometric least squares mean0.92195% CI0.8740.971Linear mixed effects model
Primary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞])

Time frame:Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

PK: Maximum Concentration (Cmax) of Tirzepatide

Time frame:Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose

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.