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

The purpose of this study is to assess the amount of LY3537031 that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment and to healthy participants.

Study Overview

• Status: Completed
• Conditions: Healthy; Renal Insufficiency; Renal Impairment; End Stage Renal Disease (ESRD)
• Intervention / Treatment: Drug: LY3537031

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Christchurch, New Zealand
    • New Zealand Clinical Research Christchurch
• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
    • Orlando, Florida, United States, 32808
      • Omega Research Orlando LLC
  • Indiana
    • Indianapolis, Indiana, United States, 46202-5188
      • Indiana University School of Medicine

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) 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

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3537031 (Group 1); LY3537031 administered subcutaneously (SC) in a control group of participants with normal renal function	Drug: LY3537031; Administered SC
Experimental: LY3537031 (Groups 2-3); LY3537031 administered SC in groups of participants with impaired renal function	Drug: LY3537031; Administered SC
Experimental: LY3537031 (Group 3); LY3537031 administered SC in a group of participants with end-stage renal disease (ESRD) on hemodialysis	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	Predose on day 1 up to week 8 post dose
PK: Maximum Concentration (Cmax) of LY3537031	PK: Cmax of LY3537031	Predose on day 1 up to week 8 post dose

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

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2025
• Primary Completion (Actual): April 16, 2026
• Study Completion (Actual): April 16, 2026

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Failure, Chronic
• Other Study ID Numbers: 27393; J2S-MC-GZMM (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