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| ID | Type | Description | Link |
|---|---|---|---|
| J3R-MC-YDAJ | Other Identifier | Eli Lilly and Company |
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The purpose of the study is to assess the amount of Eloralintide (LY3841136) 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 and to healthy participants. The study drug will be administered subcutaneously (SC) (under the skin).
For each participant, the study will last about 14 weeks, excluding screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eloralintide (Group 1) | Experimental | Eloralintide administered subcutaneously (SC) in a control group of participants with normal renal function |
|
| Eloralintide (Groups 2 and 3) | Experimental | Eloralintide administered SC in groups of participants with impaired renal function |
|
| Eloralintide (Group 3) | Experimental | Eloralintide administered SC in a group of participants with end-stage renal disease (ESRD) on stable hemodialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3841136 | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3841136 | Predose on Day 1 up to Day 71 | |
| PK: Maximum Observed Drug Concentration (Cmax) of LY3841136 | Predose on Day 1 up to Day 71 |
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Inclusion Criteria:
Additional Inclusion Criteria for Group 1
Additional Inclusion Criteria for Groups 2 and 3
Exclusion Criteria:
Groups 2 and 3
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| 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 |
|---|---|---|---|---|---|---|
| Floridian Clinical Research, LLC | Recruiting | Miami Lakes | Florida | 33016-1518 | United States |
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| Omega Research Orlando LLC | Recruiting | Orlando | Florida | 32808 | United States |
|
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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