A Study of LY3502970 in 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 learn more about the safety of LY3502970 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3502970 is in the bloodstream, how long it takes the body to eliminate it, and how it affects blood sugar. Participation could last up to 18 weeks and may include up to 14 visits (including three overnight stays) in the study center.

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

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: Have type 2 diabetes mellitus (T2DM) for at least 6 months Have a glycated hemoglobin (HbA1c) value at screening of greater than or equal to (≥)7.0 percent (%) and less than or equal to (≤)10.5% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening Have a body weight of ≥45 kilograms (kg) and have a body mass index of 18.5 to 45 kilograms per square meter (kg/m²), inclusive Have had a stable body weight for the 3 months prior to screening (less than [<]5% body weight change) Males and females (not considered woman of childbearing potential) Exclusion Criteria: Have type 1 diabetes mellitus, latent autoimmune diabetes in adults or have had an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening Have had any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure Show evidence of hepatitis B, and/or positive hepatitis B surface antigen Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies Any glucose-lowering medications other than metformin within 3 months prior to screening

Ages Eligible for Study
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Minimum Age: 18 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: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3502970<br>LY3502970 administered orally. | Drug: LY3502970<br>* Administered orally.<br>|
| Placebo Comparator: Placebo<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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | 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 (up to Day 105) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970 | Day 1 through Day 84: Predose up to 96 hours postdose | 
| PK: Area Under the Concentration Versus Time Curve of LY3502970 | PK: AUC of LY3502970 | Day 1 through Day 84: Predose up to 96 hours postdose | 
| Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG) | Pharmacodynamics (PD): Change from Baseline to Week 12 in FPG | Baseline, Week 12 | 
| PD: Change from Baseline to Week 12 in Fasting Insulin | PD: Change from Baseline to Week 12 in Fasting Insulin | Baseline, Week 12 |