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| ID | Type | Description | Link |
|---|---|---|---|
| J3H-JE-GZNG | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3549492 Part A | Experimental | LY3549492 administered orally |
|
| LY3549492 Part B | Experimental | LY3549492 administered orally |
|
| Placebo Part A | Placebo Comparator | Placebo administered orally |
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| Placebo Part B | Placebo Comparator | Placebo administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3549492 | Drug | Administered orally |
| |
| 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 and SAEs regardless of causality, will be reported in the Reported Adverse Events module | Day 1 Through Day 127 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3549492 | PK: AUC of LY3549492 | Day 1 Through Day 127 |
| PK: Maximum Concentration (Cmax) of LY3549492 | PK: Cmax of LY3549492 |
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Inclusion Criteria:
Part A:
Participants with T2DM for at least 6 months
With an HbA1c value:
Have had a stable weight for the 3 months prior to screening. Stable weight is defined as less than 5% body weight change
Part B:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hakata Clinic | Fukuoka | 812-0025 | Japan | |||
| P-One Clinic |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo |
| Drug |
Administered orally |
|
| Day 1 Through Day 127 |
| Pharmacodynamic (PD): Part A: Change from Baseline in Hemoglobin A1c (HbA1c) | PD: Change from Baseline in Hemoglobin A1c (HbA1c) | Day 1 Through Day 127 |
| PD: Change from Baseline in Body Weight | PD: Change from Baseline in Body Weight | Day 1 Through Day 127 |
| HachiĆji |
| 192-0071 |
| Japan |
| Medical Corporation Heishinkai OPHAC Hospital | Osaka | 532-0003 | Japan |
| Clinical Research Hospital Tokyo | Shinjuku-ku | 160-0004 | Japan |