A Study of LY3437943 in Participants With Impaired and Normal Liver Function

Study Overview
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Brief Summary
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The main purpose of this study is to measure how much of LY3437943 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to healthy participants with normal liver function. The safety and tolerability of LY3437943 will also be evaluated. The study may last up to 9 weeks for each participant including the screening period.

Official Title
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A Parallel-Group, Single-Dose, Phase 1, Open-Label Study to Investigate the Pharmacokinetics of LY3437943 in Participants With Hepatic Impairment Compared With Healthy Participants

Conditions
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Healthy, Hepatic Insufficiency

Intervention / Treatment
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* Drug: LY3437943


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All Participants: Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²), inclusive Healthy or various degrees of hepatic impairment depending on the study group Exclusion Criteria: Participants with hepatic impairment: Have or are anticipating an organ transplant within the next 6 months Requires needle evacuation of ascites fluid more than 2 times per month Have had variceal bleeding within 3 months of check-in, unless the participant has undergone a successful banding procedure; in that case, may check-in from 1 month after the banding procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3437943 (Normal Hepatic Function)<br>LY3437943 administered subcutaneously (SC). | Drug: LY3437943<br>* Administered SC.<br>|
| Experimental: LY3437943 (Severe Hepatic Impairment)<br>LY3437943 administered SC. | Drug: LY3437943<br>* Administered SC.<br>|
| Experimental: LY3437943 (Moderate Hepatic Impairment)<br>LY3437943 administered SC. | Drug: LY3437943<br>* Administered SC.<br>|
| Experimental: LY3437943 (Mild Hepatic Impairment)<br>LY3437943 administered SC. | Drug: LY3437943<br>* Administered SC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 30 days postdose | 
| PK: Maximum observed concentration (Cmax) of LY3437943 | PK: Cmax of LY3437943 | Predose up to 30 days postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Hepatic Impairment