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

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers, Obesity / overweight

Eligibility highlights

•BMI 18.5-45•Healthy volunteers

Primary endpoints

•AUC of Tirzepatide•PK: Maximum Concentration (Cmax) of Tirzepatide

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. 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

Tirzepatide

Who this study enrolls

Healthy volunteersObesity / overweight

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

Group	Geometric mean · Hour * nanogram per milliliter (h*ng/mL)	95% CI
Tirzepatide - Abdomen	112000	-
Tirzepatide - Upper Arm	111000	-
Tirzepatide - Thigh	106000	-

Ratio of geometric least squares mean0.95390% CI0.935 - 0.970Linear mixed effects model

Ratio of geometric least squares mean0.99090% CI0.972 - 1.01Linear 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

Group	Geometric mean · Nanogram per Millilitre (ng/mL)	95% CI
Tirzepatide - Abdomen	603	-
Tirzepatide - Upper Arm	556	-
Tirzepatide - Thigh	520	-

Ratio of geometric least squares mean0.86290% CI0.818 - 0.909Linear mixed effects model

Ratio of geometric least squares mean0.92195% CI0.874 - 0.971Linear 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 6, 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 6, 2026 snapshot.