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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.
Conditions:
🦠 Healthy 🦠 Hepatic Insufficiency
🗓️ Study Start (Actual) 13 July 2023
🗓️ Primary Completion (Estimated) January 2025
✅ Study Completion (Estimated) January 2025
👥 Enrollment (Estimated) 37
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 DeLand, Florida, United States
📍 Miami, Florida, United States
📍 San Antonio, Texas, United States
📍 San Antonio, Texas, United States

📋 Eligibility Criteria

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
Ages Eligible for Study: 18 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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 Registration Dates

  • First Submitted 15 June 2023
  • First Submitted that Met QC Criteria 15 June 2023
  • First Posted 23 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 July 2024
  • Last Update Posted 19 July 2024
  • Last Verified July 2024
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