RecruitingPhase 1

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

Lead sponsor

Eli Lilly and Company

Asset

Brenipatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

Study population

Healthy volunteers, Hepatic impairment

Eligibility highlights

•BMI 19-40•HbA1c ≤11.5%•Healthy volunteers

Primary endpoints

•AUC of LY3537031•PK: Maximum Concentration (Cmax) of LY3537031

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07165002

Org study ID27392

Secondary IDJ2S-MC-GZMLEli Lilly and Company

Timeline

Milestones

Study first posted2025-09-10actual

Study start2025-10-20actual

Last update posted2026-09-30actual

Primary completion2026-11estimated (month precision)

Study completion2026-11estimated (month precision)

Assets

Investigational agents

Brenipatide

Who this study enrolls

Healthy volunteersHepatic impairment

Who can enroll

Minimum age18 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

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)

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

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

Time frame:Baseline to Study Completion (Up to 8 Weeks)

concentration, descriptive

Primary/protocol endpoint

PK: Maximum Concentration (Cmax) of LY3537031

Time frame:Baseline to Study Completion (Up to 8 Weeks)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.