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| ID | Type | Description | Link |
|---|---|---|---|
| J3R-MC-YDAH | Other Identifier | Eli Lilly and Company | |
| 2025-523847-36-00 | EU Trial (CTIS) Number |
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The main purpose of this study is to evaluate how a medicine, LY3841136, works in participants with different levels of liver damage and in participants with healthy liver. The researchers want to see how the medicine is absorbed and used by the body, and if it causes any side effects, in participants with mild, moderate, or severe liver damage, as well as in participants with normal liver function.
For each participant, the study will last about 14 weeks, which will include a stay at the clinical research unit for 5 nights.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eloralintide (Normal Hepatic Function) | Experimental | Eloralintide administered subcutaneously (SC) |
|
| Eloralintide (Mild Hepatic Impairment) | Experimental | Eloralintide administered SC |
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| Eloralintide (Moderate Hepatic Impairment) | Experimental | Eloralintide administered SC |
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| Eloralintide (Severe Hepatic Impairment) | Experimental | Eloralintide administered SC |
|
| 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:
Group 1
Groups 2 through 4
Participants with hepatic impairment may have stable baseline medical conditions for which neither the condition nor treatments received would negatively impact the health of the participant or study conduct
Exclusion Criteria:
Group 1
Have liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 1.5 × ULN or total bilirubin (TBL) greater than 1.5 × ULN at screening
Have a current infection with hepatitis B virus (HBV), that is,
if hepatitis B surface antigen (HBsAg) is positive, the participant is excluded, or
if HBsAg is negative and anti-Hepatitis B core antibody (HBc) is positive, further testing for HBV deoxyribonucleic acid (DNA) is required, and
Have a current infection with hepatitis C virus (HCV), that is,
Groups 2, 3, and 4
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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 |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Recruiting | Orlando | Florida | 32809 | United States |
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| Label | URL |
|---|---|
| A Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers | View source |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| American Research Corporation | Recruiting | San Antonio | Texas | 78215 | United States |
|
| CRU Early Phase Unit | Recruiting | Kistarcsa | H-2143 | Hungary |
|