How LY3537031 is processed and tolerated in people with normal or impaired liver function

A Phase 1, Multicenter, Parallel-Design, Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Hepatic Function and Participants With Mild, Moderate, or Severe Hepatic Impairment

This trial will test how LY3537031 is absorbed, distributed, and cleared and whether it is safe when given under the skin to adults with normal liver function and to adults with mild, moderate, or severe liver impairment.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Eli Lilly and Company (industry)
• Locations: 3 sites (Kistarcsa and 2 other locations)
• Trial ID: NCT07165002 on ClinicalTrials.gov

What this trial studies

Participants are grouped by liver function (normal and Child-Pugh A, B, or C impairment) and will receive LY3537031 subcutaneously with timed blood sampling to measure drug concentrations and elimination. The study collects safety and tolerability data through clinical exams, vital signs, laboratory tests, and adverse event monitoring. Enrollment includes healthy volunteers and people with chronic hepatic impairment of more than six months as determined by their physician. Body weight and BMI limits apply and investigators review medical history to confirm eligibility.

Who should consider this trial

Good fit: Adults weighing at least 55 kg with a BMI of 19.0–40.0 kg/m² who are either healthy with normal liver function or have chronic hepatic impairment (Child-Pugh A, B, or C) and meet other screening criteria are eligible.

Not a fit: People with acute or unstable liver disease, significant comorbid conditions outside the eligibility criteria, or those who do not meet weight/BMI requirements are unlikely to benefit from participating in this study.

Why it matters

Potential benefit: If successful, the results could help define safe dosing and guide use of LY3537031 in people with varying degrees of liver impairment.

How similar studies have performed: Pharmacokinetic and safety studies in liver-impaired groups are a standard approach and have guided dosing for other drugs, though LY3537031 itself remains investigational and requires its own data.

Eligibility criteria

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, and other 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 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
* Clinical laboratory test results with deviations that are judged by the investigator to be compatible with the hepatic impairment of the participant, or of no additional clinical significance for this study. Abnormalities of serum glucose, serum lipids and triglycerides, urinary glucose, and urinary protein consistent with Type 2 Diabetes Mellitus (T2DM) are acceptable
* Have a systolic BP less than 150 millimeters mercury (mmHg), a diastolic BP less than 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 or less than 11.5% at the screening visit

Exclusion Criteria:

* 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)

Where this trial is running

Kistarcsa and 2 other locations

• Clinical Research Units Hungary — Kistarcsa, Hungary (RECRUITING)
• New Zealand Clinical Research Auckland — Auckland, New Zealand (RECRUITING)
• Summit Clinical Research, s.r.o. - Bratislava — Bratislava, Slovakia (RECRUITING)

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Conditions: Healthy, Hepatic Insufficiency