A Safety Study of LY3437943 Given as a Single Injection in Healthy Participants

Study Overview
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Brief Summary
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This study is being conducted to determine the side effects related to LY3437943 given as a single injection under the skin to healthy participants. Blood tests will be performed to check how much LY3437943 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3437943 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 Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3437943 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3437943
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overtly healthy male or a female who cannot get pregnant Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m²), inclusive, at screening Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study Have veins suitable for ease of blood sampling Exclusion Criteria: Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study Have previously completed or withdrawn from this study Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking during the inpatient stay in the study Have or used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 been treated with weight loss medications within 3 months of screening

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3437943<br>Escalating doses of LY3437943 administered as an injection under the skin in healthy participants | Drug: LY3437943<br>* Administered subcutaneously (SC)<br>|
| Placebo Comparator: Placebo<br>Matching placebo administered as an injection under the skin in healthy participants | 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: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3437943 | Pharmacokinetics: AUC(0-inf) of LY3437943 | Baseline through final follow-up at approximately Day 43 | 
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3437943 | Pharmacokinetics: Cmax of LY3437943 | Baseline through final follow-up at approximately Day 43 | 
| Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY3437943 | Pharmacokinetics: Tmax of LY3437943 | Baseline through final follow-up at approximately Day 43 |