NCT05810597

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to look at the amount of the study drug, tirzepatide, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of tirzepatide and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 14 weeks, including screening.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tirzepatide	Administered SC
DEVICE	Single Dose Pen	Used to administer tirzepatide SC
DEVICE	Multi-use Prefilled Pen	Used to administer tirzepatide SC

Timeline

• Start date: 2023-04-03
• Primary completion: 2023-07-17
• Completion: 2023-07-17
• First posted: 2023-04-12
• Last updated: 2024-10-15
• Results posted: 2024-10-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study