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| ID | Type | Description | Link |
|---|---|---|---|
| J1I-MC-GZBL | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to assess the amount of study drug 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 healthy participants. The study will last up to 5 weeks, excluding screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3437943 (Control) | Experimental | LY3437943 administered subcutaneous (SC) to participants with normal renal function |
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| LY3437943 (Severe Renal Impairment) | Experimental | LY3437943 administered SC to participants with severe renal impairment |
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| LY3437943 (End-Stage Renal Disease) | Experimental | LY3437943 administered SC to participants with end-stage renal disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3437943 | Drug | Administered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943 | PK: AUC0-∞ of LY3437943 | Predose up to 31 days postdose |
| PK: Maximum observed concentration (Cmax) of LY3437943 | PK: Cmax of LY3437943 | Predose up to 31 days postdose |
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Inclusion Criteria:
Normal Participants:
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 |
|---|---|---|---|---|---|---|
| Orange County Research Center | Tustin | California | 92780 | United States | ||
| Clinical Pharmacology of Miami |
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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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| ID | Term |
|---|---|
| C000729679 | retatrutide |
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| Miami |
| Florida |
| 33014-3616 |
| United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Nucleus Networks | Saint Paul | Minnesota | 55114 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |