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

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

About this trial

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

Qualifiers

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

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

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

Disqualifiers

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

Have a history of atopy; that is, severe or multiple allergic manifestations, or clinically significant multiple or severe drug allergies, or hyperesthesia, or severe posttreatment hypersensitivity reactions, or have known allergies to LY3537031, or related compounds

Have undergone any form of bariatric surgery

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

Trial design

Treatments tested in this trial

  • LY3537031

Treatment groups

32 Participants
are divided into 4 treatment groups

Sponsors and collaborators