A Phase 1, Multicenter, Open-Label, Parallel-Design Study to Assess the Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Eloralintide (LY3841136) in Participants With Mild, Moderate, or Severe Hepatic Impairment and Participants With Normal Hepatic Function
A Phase 1, Multicenter, Open-Label, Parallel-Design Study to Assess the Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Eloralintide (LY3841136) in Participants With Mild, Moderate, or Severe Hepatic Impairment and Participants With Normal Hepatic Function
The main purpose of this study is to evaluate how a medicine, LY3841136, works in participants with different levels of liver damage and in participants with healthy liver. The researchers want to see how the medicine is absorbed and used by the body, and if it causes any side effects, in participants with mild, moderate, or severe liver damage, as well as in participants with normal liver function.
For each participant, the study will last about 14 weeks, which will include a stay at the clinical research unit for 5 nights.
Inclusion Criteria:
Group 1
Groups 2 through 4
Participants with hepatic impairment may have stable baseline medical conditions for which neither the condition nor treatments received would negatively impact the health of the participant or study conduct
Exclusion Criteria:
Group 1
Have liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 1.5 × ULN or total bilirubin (TBL) greater than 1.5 × ULN at screening
Have a current infection with hepatitis B virus (HBV), that is,
if hepatitis B surface antigen (HBsAg) is positive, the participant is excluded, or
if HBsAg is negative and anti-Hepatitis B core antibody (HBc) is positive, further testing for HBV deoxyribonucleic acid (DNA) is required, and
Have a current infection with hepatitis C virus (HCV), that is,
Groups 2, 3, and 4
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