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

Phase 1

Completed

• Conditions: Healthy; Hepatic Insufficiency
• Interventions: Drug: LY3437943

• Registration Number: NCT05916560
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-23
• Study Start: 2023-07-13
• Primary Completion: 2025-03-02
• Study Completion: 2025-03-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3437943 (Moderate Hepatic Impairment)	LY3437943	LY3437943 administered SC.
LY3437943 (Mild Hepatic Impairment)	LY3437943	LY3437943 administered SC.
LY3437943 (Normal Hepatic Function)	LY3437943	LY3437943 administered subcutaneously (SC).
LY3437943 (Severe Hepatic Impairment)	LY3437943	LY3437943 administered SC.

Primary Outcome Measures

Name	Time	Method
PK: Maximum observed concentration (Cmax) of LY3437943	Predose up to 30 days postdose	PK: Cmax of LY3437943
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943	Predose up to 30 days postdose	PK: AUC0-∞ of LY3437943

Trial Locations

Locations (5)

Arizona Clinical Trials - Chandler; 🇺🇸 Chandler, Arizona, United States

Accel Research Sites- Clinical Research Unit; 🇺🇸 DeLand, Florida, United States

Advanced Pharma Clinical Research; 🇺🇸 Miami, Florida, United States

American Research Corporation at Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States

Pinnacle Clinical Research; 🇺🇸 San Antonio, Texas, United States