A Study of Multiple Doses of LY3305677 in Healthy Participants

Study Overview
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Brief Summary
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The purposes of this study are to determine: The safety of LY3305677 and any side effects that might be associated with it. How much LY3305677 gets into the bloodstream and how long it takes the body to remove it in healthy participants, including those of Japanese origin. The effect LY3305677 has on the body, particularly the effect on blood glucose levels. This study will last approximately 17 weeks not including screening. Screening is required within 4 weeks prior to start of the study. This study is for research purposes only and is not intended to treat any medical conditions.

Official Title
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A Multiple-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: Are overtly healthy males or females, as determined by medical history and physical examination Women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause Are first-generation Japanese or non-Japanese. First-generation Japanese is defined as the participant, the participant's biological parents, and all of the participant's grandparents are of exclusive Japanese descent and have been born in Japan Have a body weight of more than 54 kilograms (kg) Exclusion Criteria: Currently enrolled in a clinical study or have participated in a study within the past 3 months Have an abnormality in the 12-lead electrocardiogram (ECG) at screening Have history of pancreatitis Have known or ongoing psychiatric disorders Have undergone bariatric surgery or have used any drugs for weight loss Have a history of alcoholism Currently smoke more than 10 cigarettes a 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3305677<br>Escalating doses of LY3305677 administered by subcutaneous (SC) injection | Drug: LY3305677<br>* Administered SC<br>|
| Placebo Comparator: Placebo<br>Saline solution administered by SC injection | 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 115 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3305677 | PK: Cmax of LY3305677 | Days 1 and 29: Predose through 168 hours post dose | 
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3305677 | PK: AUC of LY3305677 | Days 1 and 29: Predose through 168 hours post dose |