A Study of LY3108743 in Healthy Participants and Participants With Type 2 Diabetes

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3108743 in healthy participants and in participants with type 2 diabetes. The study will also investigate how LY3108743 affects the levels of blood sugar and other naturally occurring substances (e.g. hormones that control the way sugar is used) in the body, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it. Information about any side effects that may occur will be collected. The study is expected to last approximately 7 to 8 weeks for each participant. The study will have up to 3 parts. Participants may enroll in only one part.

Official Title
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of LY3108743 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Placebo - Capsule
* Drug: LY3108743 - Capsule
* Drug: Placebo - Solution
* Drug: LY3108743 - Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes Have a body mass index (BMI) of 18.5 to 40.0 kilogram per square meter (kg/m^2), inclusive, at screening Have normal blood pressure Participants with diabetes must not be taking any anti-hyperglycemic medications with the exception of metformin. If on metformin, participants must be on a stable treatment regimen for at least for 4 weeks prior to screening Participants with diabetes must have a hemoglobin A1c (HbA1c) level between 6 to 11%, inclusive, at screening Exclusion Criteria: Have previously completed or withdrawn from this study Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that, in the opinion of the doctor, could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

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo - Healthy<br>Part A. Healthy participants will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods. | Drug: Placebo - Capsule<br>* Administered orally<br>|
| Experimental: LY3108743 - Healthy<br>Part A. Healthy participants will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods. | Drug: LY3108743 - Capsule<br>* Administered orally<br>|
| Placebo Comparator: Placebo - Diabetes<br>Part B. Participants with diabetes mellitus will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods. | Drug: Placebo - Capsule<br>* Administered orally<br>|
| Experimental: LY3108743 - Diabetes<br>Part B. Participants with diabetes mellitus will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods. | Drug: LY3108743 - Capsule<br>* Administered orally<br>|
| Placebo Comparator: Placebo - Solution<br>Part C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of placebo matching LY3108743 in 1 of 2 study periods. | Drug: Placebo - Solution<br>* Administered orally<br>|
| Experimental: LY3108743 - Solution<br>Part C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of LY3108743 in 1 of 2 study periods. | Drug: LY3108743 - Solution<br>* Administered orally<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 |  | Pre-dose up to Day 6 (5 days post-dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Change from Baseline up to 24 Hours in Level of Blood Glucose Before and After a Standard Meal |  | Baseline up to 24 hours | 
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3108743 |  | Baseline up to 48 hours | 
| Pharmacokinetics: Area Under the Curve (AUC) of LY3108743 |  | Baseline up to 48 hours |