A Study of LY3502970 in Participants With Type 2 Diabetes

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
LY3502970	LY3502970	LY3502970 administered orally.
Placebo	Placebo	Placebo administered orally.

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug	Baseline through Follow-up (up to Day 105)	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

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

Locations (6): Profil Institut für Stoffwechselforschung
🇩🇪
Neuss, Nordrhein-Westfalen, Germany
Endeavor Clinical Trials
🇺🇸
San Antonio, Texas, United States
Hassman Research Institute
🇺🇸
Marlton, New Jersey, United States
Midwest Clinical Research Unit
🇺🇸
Dayton, Ohio, United States
Profil Mainz
🇩🇪
Mainz, Germany
Clinical Pharmacology of Miami
🇺🇸
Hialeah, Florida, United States

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