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| ID | Type | Description | Link |
|---|---|---|---|
| J2S-MC-GZML | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to measure how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function and in healthy participants with normal liver function. The safety and tolerability of LY3537031 will also be evaluated. The study drug will be administered subcutaneously (SC) (under the skin).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3537031 (Group 1) | Experimental | Administered subcutaneously (SC) in participants with normal hepatic function |
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| LY3537031 (Group 2) | Experimental | Administered SC in participants with mild hepatic impairment |
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| LY3537031 (Group 3) | Experimental | Administered SC in participants with moderate hepatic impairment |
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| LY3537031 (Group 4) | Experimental | Administered SC in participants with severe hepatic impairment |
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| 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 | Baseline to Study Completion (Up to 8 Weeks) |
| PK: Maximum Concentration (Cmax) of LY3537031 | PK: Cmax of LY3537031 | Baseline to Study Completion (Up to 8 Weeks) |
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Inclusion Criteria:
Additional Inclusion Criteria for Participants Without Hepatic Impairment in Group 1:
Additional Inclusion Criteria for Participants with Mild to Severe Hepatic Impairment in Groups 2 through 4:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Clinical Research Units Hungary | Recruiting | Kistarcsa | H-243 | Hungary |
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| Label | URL |
|---|---|
| A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment | View source |
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| New Zealand Clinical Research Auckland | Recruiting | Auckland | 1010 | New Zealand |
|
| Summit Clinical Research, s.r.o. - Bratislava | Recruiting | Bratislava | 831 01 | Slovakia |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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