GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT04311424

CompletedPhase 1Results posted

Study of Tirzepatide in Healthy Participants

Disposition of [14C]-Tirzepatide Following Subcutaneous Administration in Healthy Male Subjects

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18-32•Male•Healthy volunteers

Primary endpoints

•Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As•Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As

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 IDNCT04311424

Org study ID17378

Secondary ID2019-003664-44

Secondary IDI8F-MC-GPHXEli Lilly and Company

Timeline

Milestones

Study first posted2020-03-17actual

Study start2020-07-28actual

Primary completion2020-10-02actual

Study completion2020-10-02actual

Last update posted2023-03-24actual

Results first posted2023-03-24actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age30 Years

Maximum age55 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Overtly healthy males as determined by medical history, physical examination, and other screening procedures

•Have a body mass index (BMI) between 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive at screening

•Are willing to be available for the full duration of the study

Exclusion criteria

•Have known allergies to tirzepatide or related compounds

•Have a medical condition or medical history that makes participation in the study unsafe or which may interfere in the interpretation of the results of the study

•Have had exposure to significant radiation within 12 months prior to dosing (for example, multiple x-ray or computed tomography [CT] scans, barium meal, being employed in a job requiring radiation exposure monitoring)

•Have participated in any clinical trial involving a radiolabeled substance within the past 12 months

Endpoints (16)

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

Other (unclassified)

Safety / tolerability / PK

14 endpoints

Primary/registry result

Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered

Time frame:Pre-dose and up to 63 days post-dose

descriptive

Posted result

Group	Value (mean), Percentage of the total radioactive dose	95% CI
[14C]-Tirzepatide	49.56	—

Primary/registry result

Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered

Time frame:Pre-dose and up to 63 days post-dose

descriptive

Posted result

Group	Value (mean), Percentage of the total radioactive dose	95% CI
[14C]-Tirzepatide	20.46	—

Primary/protocol endpoint

Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered

Time frame:Pre-dose and up to 63 days post-dose

descriptive

Primary/protocol endpoint

Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered

Time frame:Pre-dose and up to 63 days post-dose

percent change from baseline, descriptive

Secondary/registry result/low confidence

Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable)

Time frame:Pre-dose and up to 63 days post-dose

percent change from baseline, descriptive

componentsurine radioactivity recovery, feces radioactivity recovery, expired air radioactivity recovery

Posted result

Group	Value (mean), Percentage of the total radioactive dose	95% CI
[14C]-Tirzepatide	70.03	—

Secondary/registry result

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

Time frame:Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramhour per milliliter (ngh/mL)	95% CI
[14C]-Tirzepatide	96100	—

Secondary/registry result

PK: Maximum Concentration (Cmax) of Tirzepatide

Time frame:Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng/mL	95% CI
[14C]-Tirzepatide	453	—

Secondary/registry result

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

Time frame:Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), h*ng Eq/mL	95% CI
[14C]-TirzepatidePlasma	87900	—
Whole blood	44000	—

Secondary/registry result

PK: Maximum Concentration (Cmax) of Total Radioactivity

Time frame:Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng Eq/mL	95% CI
[14C]-TirzepatidePlasma	327	—
Whole Blood	173	—

Secondary/protocol endpoint

Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable)

Time frame:Pre-dose and up to 63 days post-dose

descriptive

Secondary/protocol endpoint

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

Time frame:Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

PK: Maximum Concentration (Cmax) of Tirzepatide

Time frame:Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

PK: Maximum Concentration (Cmax) of Total Radioactivity

Time frame:Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose

Cmax

concentration, descriptive

Other (unclassified)

2 endpoints

Secondary/registry result/low confidence

Total Number of Metabolites

Time frame:Pre-dose and up to 63 days post-dose

descriptive

Posted result

Group	Value (number), metabolites	95% CI
[14C]-TirzepatidePlasma	4	—
Urine	6	—
Feces	6	—

Secondary/protocol endpoint/low confidence

Total Number of Metabolites

Time frame:Pre-dose and up to 63 days post-dose

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.