A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment

Last updated: December 3, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

1

Condition

Primary Biliary Cholangitis

Treatment

LY3537031

Clinical Study ID

NCT07165002
27392
J2S-MC-GZML
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to measure how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function and in healthy participants with normal liver function. The safety and tolerability of LY3537031 will also be evaluated. The study drug will be administered subcutaneously (SC) (under the skin).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Have no significant history of spontaneous or ethanol-induced hypoglycemia

Additional Inclusion Criteria for Participants Without Hepatic Impairment in Group 1:

  • Are healthy participants as determined by medical history, physical examination, andother screening procedures, with clinically normal hepatic function at screening

  • Have normal blood pressure (BP) and pulse rate, as determined by the investigator

Additional Inclusion Criteria for Participants with Mild to Severe Hepatic Impairment in Groups 2 through 4:

  • Participants with hepatic impairment classified as Child-Pugh score A, B, or C whoare considered acceptable for participation in this study by the investigator.Participants must have a diagnosis of chronic hepatic impairment of greater than 6months per physician diagnosis and standard-of-care practice, with no clinicallysignificant changes, in the opinion of the investigator, within 15 days prior toscreening

  • Clinical laboratory test results with deviations that are judged by the investigatorto be compatible with the hepatic impairment of the participant, or of no additionalclinical significance for this study. Abnormalities of serum glucose, serum lipidsand triglycerides, urinary glucose, and urinary protein consistent with Type 2Diabetes Mellitus (T2DM) are acceptable

  • Have a systolic BP less than 150 millimeters mercury (mmHg), a diastolic BP lessthan 90 mmHg, and a pulse rate greater than 50 but less than 100 beats per minute

  • If participants have T2DM, they must have a hemoglobin A1c measurement equal to orless than 11.5% at the screening visit

Exclusion

Exclusion Criteria:

  • Have significant history of or current cardiovascular, respiratory, hepatic (hepaticapplies to Group 1 only), renal, gastrointestinal (GI), endocrine, hematological,dermatological, or neurological disorders capable of significantly altering theabsorption, metabolism, or elimination of drugs; of constituting a risk when takingthe investigational medicinal product; or of interfering with the interpretation ofdata

  • Have a history of atopy; that is, severe or multiple allergic manifestations, orclinically significant multiple or severe drug allergies, or hyperesthesia, orsevere posttreatment hypersensitivity reactions, or have known allergies toLY3537031, or related compounds

  • Have undergone any form of bariatric surgery

  • Have a history of or current acute or chronic pancreatitis, or elevation in serumlipase or amylase or both greater than 1.5× upper limits of normal (ULN)

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: LY3537031
Phase: 1
Study Start date:
October 20, 2025
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Clinical Research Units Hungary

    Kistarcsa 3050290, H-243
    Hungary

    Active - Recruiting

  • New Zealand Clinical Research Auckland

    Auckland 2193733, 1010
    New Zealand

    Active - Recruiting

  • Summit Clinical Research, s.r.o. - Bratislava

    Bratislava 3060972, 831 01
    Slovakia

    Active - Recruiting

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