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| ID | Type | Description | Link |
|---|---|---|---|
| I8H-JE-BDCF | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. The study will last about four weeks, not including screening. Screening is required within 4 weeks before the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3209590 | Experimental | Insulin naïve participants with Type 2 Diabetes Mellitus received 5 mg and 10 mg LY3209590 administered subcutaneously (SC) in Cohort 1 and 2 respectively. Participants with T2DM received 20 mg LY3209590 administered subcutaneously in Cohort 3. |
|
| Placebo | Active Comparator | Participants from Cohort 1 and 2 received Placebo administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3209590 | Drug | Administered SC |
| |
| Placebo |
| 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 Administration | 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 Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3209590 | PK: Cmax of LY3209590 | Baseline through Day 28 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3209590 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P-one clinic | Hachiōji | Tokyo | 192-0071 | Japan | ||
| Sumida Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39928225 | Derived | Nasu R, Oura T, Ohwaki K, Imori M, Furihata K. Pharmacokinetic and Pharmacodynamic Properties of Once-Weekly Insulin Efsitora Alfa in Japanese Patients with Type 2 Diabetes. Diabetes Ther. 2025 Mar;16(3):513-526. doi: 10.1007/s13300-025-01695-x. Epub 2025 Feb 10. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Cohort 3 is open-label.
| Drug |
Administered SC |
|
PK: AUC of LY3209590
| Baseline through Day 28 |
| Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose | PD: Change from Baseline in Fasting Plasma Glucose | Baseline through Day 15 |
| Sumida-ku |
| Tokyo |
| 130-0004 |
| Japan |
| Hakata Clinic | Fukuoka | 812-0025 | Japan |
| D004700 | Endocrine System Diseases |