The purpose of this study is to evaluate how well LY3549492 is tolerated and what side effects may occur in Japanese participants with Type 2 Diabetes Mellitus (T2D) and healthy Japanese participants. The study drug will be administered orally. Blood tests will be performed to check how much LY3549492 gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 19 weeks for both Part A (Cohorts 1-3) for multiple-ascending doses (MAD), and Part B (Cohorts 4-5) multiple-ascending doses (MAD), for a total of approximately 25 weeks, including screening.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
92
Administered orally
Administered orally
Hakata Clinic
Fukuoka, Japan
P-One Clinic
Hachiōji, Japan
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Japan
Clinical Research Hospital Tokyo
Shinjuku-ku, Japan
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 and SAEs regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Day 1 Through Day 127
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3549492
PK: AUC of LY3549492
Time frame: Day 1 Through Day 127
PK: Maximum Concentration (Cmax) of LY3549492
PK: Cmax of LY3549492
Time frame: Day 1 Through Day 127
Pharmacodynamic (PD): Part A: Change from Baseline in Hemoglobin A1c (HbA1c)
PD: Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Day 1 Through Day 127
PD: Change from Baseline in Body Weight
PD: Change from Baseline in Body Weight
Time frame: Day 1 Through Day 127
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