A Study of LY3192767 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to investigate the side effects related to LY3192767 when given as an injection under the skin to healthy participants. Blood tests will be done to check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and Part B. Each participant will enroll in one part. For each participant, Part A will last up to about 32 days after last dose and Part B will last up to about 49 days after last dose. Screening must be completed prior to study start.

Official Title
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A Single-Site, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Glucodynamic Effects of LY3192767 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3192767
* Drug: Basal Insulin Peglispro
* Drug: Insulin Glargine
* 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 Have a body mass index (BMI) of >18.5 and <30.0 kilogram per square meter (kg/m²), inclusive Exclusion Criteria: Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed Have participated as a participant in a first-in-human study within 90 days of the initial dose of study drug Have known allergies to insulin, heparin, or related drugs, or history of relevant allergic reactions of any origin Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, chronic inflammatory disease, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 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: LY3192767 (Part A)<br>Escalating doses of LY3192767 administered subcutaneously (SC). | Drug: LY3192767<br>* Administered SC.<br>|
| Placebo Comparator: Placebo (Part A)<br>Placebo matching LY3192767 administered subcutaneously (SC). | Drug: Placebo<br>* Administered SC.<br>|
| Experimental: LY3192767 (Part B)<br>LY3192767 administered as a SC injection in one of three study periods. | Drug: LY3192767<br>* Administered SC.<br>|
| Active Comparator: Basal Insulin Peglispro (Part B)<br>Basal insulin peglispro administered as a SC injection in one of three study periods. | Drug: Basal Insulin Peglispro<br>* Administered SC.<br>* Other names: LY2605541;|
| Active Comparator: Insulin Glargine (Part B)<br>Insulin glargine administered as a SC injection in one of three study periods. | Drug: Insulin Glargine<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 Study Completion (up to about Day 49) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3192767 | PK: Tmax of LY3192767 | Predose through 336 Hours | 
| PK: Maximum Serum Concentration (Cmax) of LY3192767 | PK: Cmax of LY3192767 | Predose through 336 Hours | 
| PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3192767 | PK: AUC(0-inf) of LY3192767 | Predose through 336 Hours | 
| Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) of LY3192767 | PD: Total Amount of Glucose Infused (Gtot) of LY3192767 | Predose through 36 Hours During Clamp Procedure | 
| PD: Maximum Glucose Infusion Rate (Rmax) of LY3192767 | PD: Rmax of LY3192767 | Predose through 36 Hours During Clamp Procedure | 
| PD: Time of Maximum Glucose Infusion Rate (TRmax) of LY3192767 | PD: TRmax of LY3192767 | Predose through 36 Hours During Clamp Procedure | 
| PD: Change from Baseline in Free Fatty Acids | PD: Change from Baseline in Free Fatty Acids | Predose through 48 Hours Postdose | 
| PD: Change from Baseline in Glycerol | PD: Change from Baseline in Glycerol | Predose through 48 Hours Postdose | 
| PD: Change from Baseline in Triglycerides | PD: Change from Baseline in Triglycerides | Predose through 48 Hours Postdose |