A Study of LY3537031 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 LY3537031 in healthy participants. The blood tests will be performed to check how much LY3537031 gets into the bloodstream, how long the body takes to eliminate it and how body handles LY3537031. Each participant will receive a single dose of LY3537031 or placebo. The study will last up to approximately 71 days for each participant, including screening.

Official Title
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A Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3537031 in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3537031
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are male or female not of childbearing potential Have a body mass index (BMI) between 19 and 35 kilograms per square meter (kg/m²) and a body weight ≥ 54 kilograms (kg) Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study Have veins suitable for blood sampling Exclusion Criteria: Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study Have a diagnosis or history of cancer or malignant disease within 5 years Have been treated with prescription and over-the-counter medications that promote weight loss within 3 months prior to screening Show clinical evidence of syphilis, HIV, hepatitis C, or hepatitis B, and/or test positive Have undergone any form of bariatric surgery Have previously completed or withdrawn from this study Are currently participating in or completed a clinical trial within the last 3 months Regularly use known drugs of abuse or with positive drug results Smoke >10 cigarettes per day or the equivalent, or are unable or unwilling to refrain from nicotine during CRU admission

Ages Eligible for Study
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Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3537031<br>LY3537031 administered subcutaneously (SC). | Drug: LY3537031<br>* Administered SC.<br>|
| Placebo Comparator: Placebo<br>Placebo administered SC. | Drug: Placebo<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 One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through final follow-up at approximately Day 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537031 | PK: AUC of LY3537031 | Baseline through final follow-up at approximately Day 43 | 
| PK: Maximum Concentration (Cmax) of LY3537031 | PK: Cmax of LY3537031 | Baseline through final follow-up at approximately Day 43 |