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| ID | Type | Description | Link |
|---|---|---|---|
| J1I-JE-GZBC | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to learn about the side effects of LY3437943 when given to Japanese participants with type 2 diabetes mellitus. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943 or placebo given just under the skin. For each participant, the study will last up to 5 months, inclusive of screening and will include 16 visits to the study center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3437943 | Experimental | LY3437943 administered subcutaneously (SC) |
|
| Placebo | Placebo Comparator | Placebo administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3437943 | 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 106 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943 | PK: Cmax of LY3437943 | Predose on Day 1 through Day 81 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943 | PK: AUC of LY3437943 |
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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 |
|---|---|---|---|---|---|---|
| Medical Corporation Heishinkai OCROM Clinic | Suita-shi | Osaka | 565-0853 | Japan | ||
| P-one clinic |
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| Label | URL |
|---|---|
| A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM) | View source |
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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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| ID | Term |
|---|---|
| C000729679 | retatrutide |
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| Drug |
Administered SC |
|
| Predose on Day 1 through Day 81 |
| Change from Baseline in Mean Daily Plasma Glucose (PG) | Change from baseline in mean daily PG from 6-point PG profile | Baseline through Day 80 |
| Change from Baseline in Glycated Hemoglobin (HbA1c) | Change from Baseline in HbA1c | Baseline through Day 78 |
| Change from Baseline in Fasting Glucose | Change from Baseline in Fasting Glucose | Baseline through Day 78 |
| Change from Baseline in Body Weight | Change from Baseline in Body Weight | Baseline through Day 78 |
| HachiĆji |
| Tokyo |
| 192-0071 |
| Japan |
| Clinical Research Hospital Tokyo | Shinjuku-ku | Tokyo | 162-0053 | Japan |
| Yokohama Minoru Clinic | Yokohama | 232-0064 | Japan |
| D004700 | Endocrine System Diseases |