Phase
Condition
Primary Biliary Cholangitis
Treatment
LY3537031
Clinical Study ID
Ages 18-85 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
Clinical Research Units Hungary
Kistarcsa 3050290, H-243
HungaryActive - Recruiting
New Zealand Clinical Research Auckland
Auckland 2193733, 1010
New ZealandActive - Recruiting
Summit Clinical Research, s.r.o. - Bratislava
Bratislava 3060972, 831 01
SlovakiaActive - Recruiting

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