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

NCT07165002 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27392J2S-MC-GZML
• Study Type: interventional
• Target: 32
• Locations: 3 countries
• Sites: 3

Brief 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).

Conditions

Healthy; Hepatic Insufficiency

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537031

  PK: AUC of LY3537031

  Baseline to Study Completion (Up to 8 Weeks)

• PK: Maximum Concentration (Cmax) of LY3537031

  PK: Cmax of LY3537031

  Baseline to Study Completion (Up to 8 Weeks)

Study Arms (4)

LY3537031 (Group 1)

EXPERIMENTAL

Administered subcutaneously (SC) in participants with normal hepatic function

Drug: LY3537031

LY3537031 (Group 2)

EXPERIMENTAL

Administered SC in participants with mild hepatic impairment

Drug: LY3537031

LY3537031 (Group 3)

EXPERIMENTAL

Administered SC in participants with moderate hepatic impairment

Drug: LY3537031

LY3537031 (Group 4)

EXPERIMENTAL

Administered SC in participants with severe hepatic impairment

Drug: LY3537031

Interventions

LY3537031 DRUG

Administered SC

LY3537031 (Group 1); LY3537031 (Group 2); LY3537031 (Group 3); LY3537031 (Group 4)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Clinical Research Units Hungary

Kistarcsa, H-243, Hungary

RECRUITING

New Zealand Clinical Research Auckland

Auckland, 1010, New Zealand

RECRUITING

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

Bratislava, 831 01, Slovakia

RECRUITING

Related Links

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

MeSH Terms

Conditions

Hepatic Insufficiency

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1); HU (1); NZ (1)