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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Hepatic Insufficiency; Healthy
• Intervention / Treatment: Drug: LY3537031

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• Hungary
  • Kistarcsa, Hungary, H-243
    • Recruiting
    • Clinical Research Units Hungary
    • Principal Investigator: Geza Lakner
    • Contact: Phone Number: +36 28 999 640
• New Zealand
  • Auckland, New Zealand, 1010
    • Recruiting
    • New Zealand Clinical Research Auckland
    • Principal Investigator: Edward Gane
    • Contact: Phone Number: 0800 788 3437
• Slovakia
  • Bratislava, Slovakia, 831 01
    • Recruiting
    • Summit Clinical Research, s.r.o. - Bratislava
    • Principal Investigator: Viera Kupčova
    • Contact: Phone Number: 00 421 908 729 723

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3537031 (Group 1); Administered subcutaneously (SC) in participants with normal hepatic function	Drug: LY3537031; Administered SC
Experimental: LY3537031 (Group 2); Administered SC in participants with mild hepatic impairment	Drug: LY3537031; Administered SC
Experimental: LY3537031 (Group 3); Administered SC in participants with moderate hepatic impairment	Drug: LY3537031; Administered SC
Experimental: LY3537031 (Group 4); Administered SC in participants with severe hepatic impairment	Drug: LY3537031; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: September 3, 2025
• First Submitted That Met QC Criteria: September 3, 2025
• First Posted (Estimated): September 10, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hepatic Insufficiency
• Other Study ID Numbers: 27392; J2S-MC-GZML (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No