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| ID | Type | Description | Link |
|---|---|---|---|
| J3L-MC-EZED | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to assess the amount of study drug (LY3819469) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. The safety and tolerability of LY3819469 will also be evaluated in these participants. The study will last up to 17 weeks including screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3819469 (Control) | Experimental | LY3819469 administered subcutaneously (SC) to participants with normal renal function |
|
| LY3819469 (Severe Renal Impairment) | Experimental | LY3819469 administered SC to participants with severe renal impairment |
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| LY3819469 (End-Stage Renal Disease) | Experimental | LY3819469 administered SC to participants with end-stage renal disease (ESRD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3819469 | Drug | Administered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3819469 | PK: AUC0-tlast of LY3819469 | Predose up to 85 days postdose |
| PK: Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3819469 | PK: AUC0-∞ of LY3819469 | Predose up to 85 days postdose |
| PK: Maximum observed concentration (Cmax) of LY3819469 | PK: Cmax of LY3819469 | Predose up to 85 days postdose |
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Inclusion Criteria:
Participants with Normal Renal Function:
Participants with Renal Impairment:
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 |
|---|---|---|---|---|---|---|
| Floridian Clinical Research | Miami | Florida | 33016 | United States | ||
| Advanced Pharma CR, LLC |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Miami |
| Florida |
| 33417 |
| United States |
| Omega Research Consultants | Orlando | Florida | 32808 | United States |
| Nucleus Networks | Saint Paul | Minnesota | 55114 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |