A Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers.

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Have a body weight of 55 kilograms (kg) or more and body mass index between 19.0 and 40.0 kilograms per square meter (kg/m²), inclusive

Are healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening

Have hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment who are considered acceptable for participation in this study by the investigator. Participants must have a diagnosis of chronic hepatic impairment of greater than 6 months per physician diagnosis and standard-of-care practice, with no clinically significant changes in the opinion of the investigator within 15 days prior to screening

Disqualifiers

Have a history or presence of chronic or acute pancreatitis or elevation in serum amylase or lipase greater than 1.5 × upper limit of normal (ULN)

Are pregnant or intend to become pregnant or to breastfeed during the study

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY3841136

    Drug

    Administered SC

Treatment groups

36 Participants
are divided into 4 treatment groups
Group A: Eloralintide (Normal Hepatic Function)Experimental treatment 1 intervention
Group B: Eloralintide (Mild Hepatic Impairment)Experimental treatment 1 intervention
Group C: Eloralintide (Moderate Hepatic Impairment)Experimental treatment 1 intervention
Group D: Eloralintide (Severe Hepatic Impairment)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3841136

Time frame
Predose on Day 1 up to Day 71
2

PK: Maximum Observed Drug Concentration (Cmax) of LY3841136

Time frame
Predose on Day 1 up to Day 71

Secondary outcomes

Other outcomes

Sponsors and contacts

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