CompletedPhase 1Results posted

A Study of Tirzepatide (LY3298176) in Healthy Participants

Pharmacokinetics, Safety, and Tolerability of a Solution Formulation of LY3298176 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 18.5-32•Healthy volunteers

Primary endpoints

•Pharmacokinetics (PK) Part•PK Part•PK Part B

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 IDNCT03375463

Org study ID16671

Secondary IDI8F-MC-GPGEEli Lilly and Company

Timeline

Milestones

Study first posted2017-12-18actual

Study start2017-12-19actual

Primary completion2018-12-27actual

Study completion2018-12-27actual

Last update posted2024-02-05actual

Results first posted2024-02-05actual

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Overtly healthy males or females, as determined by medical history and physical examination

•Male participants: agree to use an effective method of contraception for the duration of the study and for 3 months following the last dose of investigational product

•Female participants: not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they are greater than or equal to (≥)45 years old and have not taken hormones or oral contraceptives within the last year and had cessation of menses for at least 1 year. Or, have had at least 6 months of amenorrhea with follicle-stimulating hormone levels consistent with a postmenopausal state

•Have a body mass index of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive

Exclusion criteria

•Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

•Received treatment with a drug that has not received regulatory approval for any indication within 30 days of screening

•Have a history of heart block, or a pulse rate (PR) interval greater than (>)200 milliseconds (msec), or any abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study

•Have a significant history of or current cardiovascular (myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study medication, or interfering with the interpretation of data

Endpoints (12)

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

12 endpoints

Primary/registry result

Pharmacokinetics (PK) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide

Time frame:Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480, 816-864 hours postdose

AUC₀-∞

concentration, descriptive

Posted result

Group	Geometric mean · nanogramshours per milliliter(nghr/mL)	95% CI
5 mg Tirzepatide SC (Lyophilized)-Part A	113000	-
5 mg Tirzepatide SC (Solution)-Part A	109000	-

Primary/registry result

PK Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide

Time frame:Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480 and 816-864 hours postdose

Cmax

concentration, descriptive

Posted result

Group	Geometric mean · nanograms per milliliter (ng/mL)	95% CI
5 mg Tirzepatide SC (Lyophilized)-Part A	524	-
5 mg Tirzepatide SC (Solution)-Part A	575	-

Primary/registry result

PK Part B: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide

Time frame:Part B: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816h-864h and >=70 days post dose

AUC₀-∞

concentration, descriptive

Posted result

Group	Geometric mean · ng*hr/mL	95% CI
0.5 mg Tirzepatide IV-Part B	6680	-

Primary/protocol endpoint

Pharmacokinetics (PK) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide

Time frame:Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480, 816-864 hours postdose

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

PK Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide

Time frame:Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480 and 816-864 hours postdose

Cmax

concentration, descriptive

Primary/protocol endpoint

PK Part B: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide

Time frame:Part B: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816h-864h and >=70 days post dose

AUC₀-∞

concentration, descriptive

Secondary/registry result

PK Part C: Area Under the Concentration Versus Time Curve [AUC (0-τ)] of Tirzepatide

Time frame:Part C: Predose, 8 hours (h) (day (D)1), 24h (D2), 48h (D3),72h (D4), predose (D8), predose (D15), 8h (D15), 24h (D16), 48h (D17), 72h (D18), predose (D22), 8h (D22), 24h (D23), 48h (D24), 72h (D25), D57 and >= D96 postdose

AUC₀-∞

concentration, descriptive

Posted result

Group	Geometric mean · ng*hr/mL	95% CI
5 mg Tirzepatide SC-Part C	68900	-
7.5 mg Tirzepatide SC-Part C	149000	-

Secondary/registry result

PK Part C: Maximum Observed Drug Concentration (Cmax) of Tirzepatide

Cmax

concentration, descriptive

Posted result

Group	Geometric mean · ng/mL	95% CI
5 mg Tirzepatide SC-Part C	663	-
7.5 mg LY3298176 SC-Part C	1270	-
10 mg Tirzepatide SC-Part C	1900	-

Secondary/registry result

PK Part D: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide

Time frame:Part D: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816-864h and >= 70 days postdose

AUC₀-∞

concentration, descriptive

Posted result

Group	Geometric mean · ng*hr/mL	95% CI
0.5 mg Tirzepatide Bolus IV-Part D	14000	-

Secondary/protocol endpoint

PK Part C: Area Under the Concentration Versus Time Curve [AUC (0-τ)] of Tirzepatide

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

PK Part C: Maximum Observed Drug Concentration (Cmax) of Tirzepatide

Cmax

concentration, descriptive

Secondary/protocol endpoint

PK Part D: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide

Time frame:Part D: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816-864h and >= 70 days postdose

AUC₀-∞

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.