GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices

A Bioequivalence Study to Compare the Pharmacokinetics of Tirzepatide Administered Subcutaneously by a Test Device (Test Formulation) Versus Reference Device (Reference Formulation) in Healthy Participants

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 18.5-30•Healthy volunteers

Primary endpoints

•Cmax of Tirzepatide•PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Time t•PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity

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 IDNCT05810597

Org study ID18698

Secondary IDI8F-MC-GPIPEli Lilly and Company

Timeline

Milestones

Study start2023-04-03actual

Study first posted2023-04-12actual

Primary completion2023-07-17actual

Study completion2023-07-17actual

Last update posted2024-10-15actual

Results first posted2024-10-15actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures

•Body mass index (BMI) between 18.5 and 30.0 kilograms per meter squared (kg/m²), inclusive, at screening

•Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study

•Are agreeable to receiving study treatment by injections under the skin

•Are agreeable to following study contraception requirements

Exclusion criteria

•Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

•Smoke more than the equivalent of 10 cigarettes per day

•Is a known user of drugs of abuse

Endpoints (6)

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

6 endpoints

Primary/registry result

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide

Time frame:Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanograms per milliliter (ng/mL)	95% CI
Tirzepatide (SDP)	647	—
Tirzepatide (MUPFP)	524	—

Primary/registry result

PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-t]) of Tirzepatide

Time frame:Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogram hour per milliliter (ngh/mL)	95% CI
Tirzepatide (SDP)	124000	—
Tirzepatide (MUPFP)	118000	—

Primary/registry result

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

Time frame:Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng*h/mL	95% CI
Tirzepatide (SDP)	126000	—
Tirzepatide (MUPFP)	119000	—

Primary/protocol endpoint

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide

Time frame:Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.

Cmax

concentration, descriptive

Primary/protocol endpoint

PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-t]) of Tirzepatide

Time frame:Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

Time frame:Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.

AUC₀–∞

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.