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| ID | Type | Description | Link |
|---|---|---|---|
| J2S-MC-GZMM | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to assess the amount of LY3537031 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3537031 (Group 1) | Experimental | LY3537031 administered subcutaneously (SC) in a control group of participants with normal renal function |
|
| LY3537031 (Groups 2-3) | Experimental | LY3537031 administered SC in groups of participants with impaired renal function |
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| LY3537031 (Group 3) | Experimental | LY3537031 administered SC in a group of participants with end-stage renal disease (ESRD) on hemodialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3537031 | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537031 | PK: AUC of LY3537031 | Predose on day 1 up to week 8 post dose |
| PK: Maximum Concentration (Cmax) of LY3537031 | PK: Cmax of LY3537031 | Predose on day 1 up to week 8 post dose |
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Inclusion Criteria:
Additional Inclusion Criteria for Healthy Participants in Control Group:
Additional Inclusion Criteria for Participants with Severe Renal Impairment or with End-Stage Renal Disease (ESRD):
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 |
|---|---|---|---|---|---|---|
| Omega Research Orlando LLC | Orlando | Florida | 32808 | United States | ||
| Orlando Clinical Research Center |
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| Label | URL |
|---|---|
| A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment | View source |
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| Orlando |
| Florida |
| 32809 |
| United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202-5188 | United States |
| New Zealand Clinical Research Christchurch | Christchurch | New Zealand |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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