A Study of LY3463251 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 and tolerability (side effects) of single (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen. This is a two-part study. Participants will enroll in only one part. For each participant, Part A will last about 10 weeks and Part B will last about 23 weeks, including screening.

Official Title
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A Randomized, Placebo-Controlled, Subject- and Investigator-Blind, Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetics Study of LY3463251 in Healthy and Overweight Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3463251
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females Exclusion Criteria: Diagnosed with Type 1 or Type 2 diabetes Women who are of childbearing potential or who are breastfeeding Donated blood of more than 500 millilitres (mL) within the previous 3 months of study screening Have used any tobacco product within 3 months of Day -1, or are unwilling to refrain from the use of tobacco during the study

Ages Eligible for Study
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Minimum Age: 18 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: LY3463251 Single dose<br>Single dose of LY3463251 administered subcutaneously (SC) | Drug: LY3463251<br>* Administered SC<br>|
| Placebo Comparator: Placebo Single dose<br>Single dose of placebo administered SC | Drug: Placebo<br>* Administered SC<br>|
| Experimental: LY3463251 Multiple Dose<br>Multiple doses of LY3463251 administered SC | Drug: LY3463251<br>* Administered SC<br>|
| Placebo Comparator: Placebo Multiple Dose<br>Multiple doses of 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 follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 | PK: Cmax of LY3463251 | Baseline to Day 29 (Part A); Baseline to Day 107 (Part B) | 
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3463251 | PK: AUC of LY3463251 | Baseline to Day 29 (Part A); Baseline to Day 107(Part B) | 
| Pharmacodynamics (PD): AUC of glucose | PD: AUC of glucose | Baseline to Day 85 (Part B) | 
| Change from Baseline in Body Weight | Change from Baseline in Body Weight | Baseline, Day 85 (Part B) |