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| ID | Type | Description | Link |
|---|---|---|---|
| J3L-MC-EZEH | Other Identifier | Eli Lilly and Company | |
| 2024-520315-40-00 | Other Identifier | EU CT |
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The main purpose of this study is to evaluate how much lepodisiran gets into the blood stream and how long it takes the body to get rid of it when given as a subcutaneous (SC) injection under the skin to participants with mild, moderate, or severe liver function impairment compared to participants with normal liver function. The study will also evaluate how well lepodisiran is tolerated and what side effects may occur in these participants.
The study will last up to approximately 9 weeks, excluding screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lepodisiran Group 1 | Experimental | Lepodisiran administered subcutaneously (SC) |
|
| Lepodisiran Group 2 | Experimental | Lepodisiran administered SC |
|
| Lepodisiran Group 3 | Experimental | Lepodisiran administered SC |
|
| Lepodisiran Group 4 | Experimental | Lepodisiran administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lepodisiran | Drug | Lepodisiran administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Lepodisiran | PK: AUC of Lepodisiran | Baseline Up to 9 weeks |
| PK: Maximum Concentration (Cmax) of Lepodisiran | PK: Cmax of Lepodisiran | Baseline Up to 9 weeks |
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Inclusion Criteria:
Have a body weight of 55 kilogram (kg) or more and body mass index within the range 19.0 to 42.0 kilogram per square meter (kg/m²)
Additional Inclusion Criteria for Participants Without Hepatic Impairment in Group 1:
For Participants with Mild to Severe Hepatic Impairment in Groups 2 through 4:
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 |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami | Miami | Florida | 33014-3616 | United States | ||
| Orlando Clinical Research Center |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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|
| Orlando |
| Florida |
| 32809 |
| United States |
| American Research Corporation at Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| CRU Early Phase Unit | Kistarcsa | H-2143 | Hungary |