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

April 17, 2025 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Arizona Clinical Trials - Chandler
    • Florida
      • DeLand, Florida, United States, 32720
        • Accel Research Sites- Clinical Research Unit
      • Miami, Florida, United States, 33147-4040
        • Advanced Pharma Clinical Research
    • Texas
      • San Antonio, Texas, United States, 78229
        • Pinnacle Clinical Research
      • San Antonio, Texas, United States, 78215
        • American Research Corporation at Texas Liver Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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
Time Frame: Predose up to 30 days postdose
PK: AUC0-∞ of LY3437943
Predose up to 30 days postdose
PK: Maximum observed concentration (Cmax) of LY3437943
Time Frame: Predose up to 30 days postdose
PK: Cmax of LY3437943
Predose up to 30 days postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2023

Primary Completion (Actual)

March 2, 2025

Study Completion (Actual)

March 2, 2025

Study Registration Dates

First Submitted

June 15, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18531
  • J1I-MC-GZBT (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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