Study S000268

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

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT05810597
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 65
Start: 2023-04-03
Primary completion: 2023-07-17
Lead sponsor: Eli Lilly and Company
Conditions: Healthy
Interventions: DRUG:Tirzepatide; DEVICE:Single Dose Pen; DEVICE:Multi-use Prefilled Pen
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: OTHER:I8F-MC-GPIP

Registered primary outcomes

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

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