CompletedPhase 1Results posted

A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants

A Study to Compare the Pharmacokinetics of Tirzepatide Administered Subcutaneously by an Autoinjector Versus Prefilled Syringe in Healthy Subjects

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 18-32•Healthy volunteers

Primary endpoints

•AUC of Tirzepatide•PK: Maximum Observed Plasma 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 IDNCT04004988

Org study ID17105

Secondary IDI8F-MC-GPGSEli Lilly and Company

Timeline

Milestones

Study first posted2019-07-02actual

Study start2019-08-19actual

Primary completion2019-12-16actual

Study completion2019-12-16actual

Last update posted2023-04-18actual

Results first posted2023-04-18actual

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age21 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 18.0 and 32.0 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 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 (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf)

Time frame:Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose

AUC₀-∞

concentration, descriptive

Posted result

Group	Geometric mean · Nanogramhour per milliliter (ngh/mL)	95% CI
5 mg Tirzepatide AI	101000	-
5 mg Tirzepatide PFS	104000	-

Primary/registry result

PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide

Time frame:Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose

Cmax

concentration, descriptive

Posted result

Group	Geometric mean · Nanogram per Milliliter (ng/mL)	95% CI
5 mg Tirzepatide AI	530	-
5 mg Tirzepatide PFS	556	-

Primary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf)

Time frame:Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide

Time frame:Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose

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.