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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy; Hepatic Insufficiency

Treatments: Drug: LY3437943

Study type: Interventional

Funder types: Industry

Identifiers

NCT05916560

J1I-MC-GZBT (Other Identifier)

18531

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 4 patient groups

LY3437943 (Normal Hepatic Function)

Experimental group

Description:

LY3437943 administered subcutaneously (SC).

Treatment:

Drug: LY3437943

LY3437943 (Severe Hepatic Impairment)

Experimental group

Description:

LY3437943 administered SC.

Treatment:

Drug: LY3437943

LY3437943 (Moderate Hepatic Impairment)

Experimental group

Description:

LY3437943 administered SC.

Treatment:

Drug: LY3437943

LY3437943 (Mild Hepatic Impairment)

Experimental group

Description:

LY3437943 administered SC.

Treatment:

Drug: LY3437943