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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT05916560 (opens ClinicalTrials.gov in a new tab)Other id18531Other idJ1I-MC-GZBT
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
43 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
13 Jul 2023
Primary completion
2 Mar 2025
Completion
2 Mar 2025
First posted
23 Jun 2023
Last update posted
18 Apr 2025
Conditions
Healthy · Hepatic Insufficiency

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 1

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

    NCT05916560

    13 Jul 2023 to 2 Mar 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LY3437943Drug

Arms4

  • Experimental

    LY3437943 (Normal Hepatic Function)

    LY3437943 administered subcutaneously (SC).

  • Experimental

    LY3437943 (Severe Hepatic Impairment)

    LY3437943 administered SC.

  • Experimental

    LY3437943 (Moderate Hepatic Impairment)

    LY3437943 administered SC.

  • Experimental

    LY3437943 (Mild Hepatic Impairment)

    LY3437943 administered SC.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    PK: AUC0-∞ of LY3437943

  2. PK: Maximum observed concentration (Cmax) of LY3437943

    Time frame · Predose up to 30 days postdose

    Registry description

    PK: Cmax of LY3437943

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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