CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 65 enrolled
Drug / intervention
Tirzepatide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05810597
NCT05810597Phase 1Completed
CompareCT.gov

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

Eli Lilly and Company·interventional·Posted Apr 12, 2023·Updated Oct 15, 2024

In Brief

A Phase 1 clinical trial evaluating Tirzepatide, Single Dose Pen, and 1 other intervention for Healthy. Completed, enrolled 65 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedApr 12, 2023
Enrollment StartApr 3, 2023
Primary CompletionJul 17, 2023
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 3.2 years ago

Interventions

Tirzepatidedrug

Administered SC

Single Dose Pendevice

Used to administer tirzepatide SC

Multi-use Prefilled Pendevice

Used to administer tirzepatide SC