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

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.

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Key information

Conditions

Healthy Digestive System Diseases Hepatic Insufficiency Liver Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arizona Clinical Trials - Chandler, Chandler, Arizona, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3437943

Drug

Administered SC.

Primary outcomes

Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943

Time frame: Predose up to 30 days postdose

PK: AUC0-∞ of LY3437943
PK: Maximum observed concentration (Cmax) of LY3437943

Time frame: Predose up to 30 days postdose

PK: Cmax of LY3437943

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Jun 23, 2023
Registry last updated: Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed