A Study of LY3041658 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the safety and tolerability of LY3041658 in healthy participants. The study will measure how the body absorbs, breaks down and gets rid of LY3041658.

Official Title
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A Single Dose, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Injections of LY3041658 in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3041658


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and ECG. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Have Body mass index (BMI) within the range 18.5 - 35.0 kilograms per square meter (kg/m2) (inclusive). Exclusion Criteria: Have a significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immune, neurological, dermatological, or psychiatric disorder capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the Study intervention or interfering with the interpretation of data. Have self-perceived dullness or loss of sensation on either side of their abdomen. Have any condition that could affect pain perception from an injection. Have excessive tattoos or scars over the abdomen, or other factors (eg, rash, excessive folds of skin) that, in the investigator's opinion, would interfere with injection site assessments.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3041658 Low Dose<br>LY3041658 administered by subcutaneous (SC) injection. | Drug: LY3041658<br>* Administered SC<br>|
| Experimental: LY3041658 High Dose<br>LY3041658 administered by SC injection. | Drug: LY3041658<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With incidence and severity of Injection Site Reaction (ISR) | Number of Participants With incidence and severity of ISR | Baseline up to Day 15 | 
| Visual Analog Scale (VAS) Score for Injection Site Pain | VAS Score for Injection Site Pain | Baseline up to Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3041658 | PK: Cmax of LY3041658 | Predose up to day 85 postdose | 
| PK: Area Under the Concentration Versus Time Curve (AUC) from time 0 to infinity of LY3041658 | PK: AUC(0-inf) of LY3041658 | Predose up to day 85 postdose |