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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Tirzepatide
* Device: Test
* Device: Reference


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tirzepatide - Test<br>A single dose of tirzepatide administered by subcutaneous (SC) injection via a test device (test formulation) | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;Device: Test<br>* Used to administer tirzepatide SC<br>|
| Active Comparator: Tirzepatide - Reference<br>A single dose of tirzepatide administered by SC injection via a reference device (reference formulation) | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;Device: Reference<br>* Used to administer tirzepatide SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide | PK: Cmax of Tirzepatide | Predose up to 36 days postdose | 
| PK: Area Under the Plasma Concentration Versus Time Curve from Zero to Time t (AUC[0-t]) of Tirzepatide | PK: AUC(0-t) of Tirzepatide | Predose up to 36 days postdose | 
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide | PK: AUC(0-∞) of Tirzepatide | Predose up to 36 days postdose |