A Study of LY3305677 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety of LY3305677 and any side effects that might be associated with it. This study will also look at how much LY3305677 gets into the blood stream, how long it takes the body to remove it. This study involves a single dose of LY3305677 administered by subcutaneous injection (SC). Participation in this study is expected to last up to 16 weeks.

Official Title
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A First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3305677
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overtly healthy as determined by medical history and physical examination Male participants: will agree to use a reliable method of birth control and will not donate sperm during the study and for at least 3 months following the last dose of the investigational product Female participants: women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause First generation Japanese participants or non-Japanese participants Have a body weight of more than 50 kilograms (kg) Exclusion Criteria: Have participated within the last 3 months in a clinical trial involving an investigational product Have known allergies to glucagon-like peptide-1 (GLP-1) analogs, or any components of the formulation, or history of significant atopy Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or Day -1 Have undergone any form of bariatric surgery Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase Show evidence of human immunodeficiency virus (HIV) or Hepatitis B or C Have used or intend to use medications that promote weight loss Have donated blood of more than 500 milliliter (mL) within the last month Currently smoke more than 10 cigarettes per day

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3305677<br>Single escalating doses of LY3305677 administered subcutaneously (SC) | Drug: LY3305677<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 |  | Baseline to Study Completion (approximately 16 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3305677 |  | Day 1 Pre-dose through Day 85 | 
| Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3305677 |  | Day 1 Pre-dose through Day 85 |