A Research Study Looking at Similarity Between LY3437943 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, LY3437943, 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 LY3437943 and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 16 weeks, including screening.

Official Title
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A Relative Bioavailability Study to Compare the Pharmacokinetics of LY3437943 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: LY3437943
* 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 32.0 kilograms per meter squared (kg/m²), inclusive Have clinical laboratory test results, blood pressure and pulse rate that are acceptable for the study Are agreeable to receiving study treatment by injections under the skin Males who agree to use highly effective/effective methods of contraception and women not of childbearing potential (postmenopausal or oophorectomized) 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 Have known allergies to LY3437943 or related compounds

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: LY3437943 - Test<br>A single dose of LY3437943 administered by subcutaneous (SC) injection via a test device (test formulation) | Drug: LY3437943<br>* Administered SC<br>Device: Test<br>* Used to administer LY3437943 SC<br>|
| Active Comparator: LY3437943 - Reference<br>A single dose of LY3437943 administered by SC injection via a reference device (reference formulation) | Drug: LY3437943<br>* Administered SC<br>Device: Reference<br>* Used to administer LY3437943 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 LY3437943 | PK: Cmax of LY3437943 | Predose up to 43 days postdose | 
| PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of LY3437943 | PK: AUC[0-tlast] of LY3437943 | Predose up to 43 days postdose | 
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943 | PK: AUC(0-∞) of LY3437943 | Predose up to 43 days postdose |