CompletedPhase 1

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

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

Lead sponsor

Eli Lilly and Company

Asset

Brenipatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Actual enrollment

Study population

Chronic kidney disease, Healthy volunteers, Renal impairment

Eligibility highlights

•BMI 19-40•HbA1c ≤6.5%•eGFR ≥90•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 IDNCT07165015

Org study ID27393

Secondary IDJ2S-MC-GZMMEli Lilly and Company

Timeline

Milestones

Study first posted2025-09-10actual

Study start2025-09-18actual

Primary completion2026-04-16actual

Study completion2026-04-16actual

Last update posted2026-04-24actual

Assets

Investigational agents

Brenipatide

Who this study enrolls

Chronic kidney diseaseHealthy volunteersRenal 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) within the range 19.0 to 40.0 kilogram per square meter (kg/m²), inclusive

•Have no significant history of spontaneous or ethanol-induced hypoglycemia

Additional Inclusion Criteria for Healthy Participants in Control Group:

•Are healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function, assessed by estimated glomerular filtration rate (eGFR) of at least 90 milliliter per minute (mL/min) at screening

•Have glycated hemoglobin (HbA1c) less than or equal to 6.5% at screening

Additional Inclusion Criteria for Participants with Severe Renal Impairment or with End-Stage Renal Disease (ESRD):

•Have stable severe renal impairment, assessed by eGFR less than 30 mL/min at screening, who have been on stable hemodialysis schedule for at least 3 months prior to planned dosing

•Have acceptable blood pressure and pulse rate

•If participants have Type 2 Diabetes Mellitus (T2DM), they must have a HbA1c equal to or less than 11.5% at the screening visit

Exclusion criteria

•Have a history of chronic liver disease, acute or chronic hepatitis, including a history of autoimmune hepatitis, any evidence for hepatic impairments

•Have a current, functional renal transplant. Non-functional renal allografts may be allowed

•Have a diagnosis or history of malignant disease within 5 years before screening (some exceptions are allowed)

•Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2

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:Predose on day 1 up to week 8 post dose

concentration, descriptive

Primary/protocol endpoint

PK: Maximum Concentration (Cmax) of LY3537031

Time frame:Predose on day 1 up to week 8 post dose

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.