A Study of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The main purpose of this study is to learn about the side effects of LY3502970 when given to Japanese participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last up to 24 weeks, inclusive of screening and will include 10 visits to the study center.

Official Title
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A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: LY3502970
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females not of childbearing potential Have type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year Have glycated hemoglobin (HbA1c) value ≥ 7.0% and ≤ 10.0% for participants treated with diet and exercise or HbA1c ≥ 6.5% and ≤ 9.0% for participants who have washed out antidiabetic medications at screening Have type 2 diabetes controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (OAM); either metformin, DPP-4 (dipeptidyl peptidase-4) inhibitor, or SGLT2 (sodium-glucose co-transporter-2) inhibitor within 3 months prior to screening. Participants must withdraw from their OAM treatment for at least 28 days prior to dosing. Exclusion Criteria: Have type 1 diabetes mellitus or latent autoimmune diabetes in adults. Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization Have had an episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of >500 milligram per deciliter (mg/dL). Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 3× upper limit of normal (ULN).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: LY3502970 (Part A)<br>Single doses of LY3502970 administered orally. | Drug: LY3502970<br>* Administered orally<br>|
| Experimental: LY3502970 (Part B)<br>Multiple doses of LY3502970 administered orally. | Drug: LY3502970<br>* Administered orally<br>|
| Placebo Comparator: Placebo (Part A)<br>Placebo administered orally. | Drug: Placebo<br>* Administered orally<br>|
| Placebo Comparator: Placebo (Part B)<br>Placebo administered orally. | Drug: Placebo<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 Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Week 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970 | Predose on Day 1 through up to Day 88 | 
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970 | PK: AUC of LY3502970 | Predose on Day 1 through up to Day 88 | 
| Change from Baseline in Fasting Glucose | Change from Baseline in Fasting Glucose | Baseline through Day 85 | 
| Change from Baseline in Glycated Hemoglobin (HbA1c) | Change from Baseline in HbA1c | Baseline through Day 85 | 
| Change from Baseline in Body Weight | Change from Baseline in Body Weight | Baseline through Day 88 |