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

Not Applicable

Not yet recruiting

• Conditions: Renal Impairment; Healthy; Renal Insufficiency; End Stage Renal Disease (ESRD)
• Interventions: Drug: LY3537031

• Registration Number: NCT07165015
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-03
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study First Posted: 2025-09-10
• Last Update Posted: 2025-09-10
• Primary Completion: 2026-08
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3537031 (Group 1)	LY3537031	LY3537031 administered subcutaneously (SC) in a control group of participants with normal renal function
LY3537031 (Groups 2-3)	LY3537031	LY3537031 administered SC in groups of participants with impaired renal function
LY3537031 (Group 3)	LY3537031	LY3537031 administered SC in a group of participants with end-stage renal disease (ESRD) on hemodialysis

Primary Outcome Measures

Name	Time	Method
PK: Maximum Concentration (Cmax) of LY3537031	Predose on day 1 up to week 8 post dose	PK: Cmax of LY3537031
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537031	Predose on day 1 up to week 8 post dose	PK: AUC of LY3537031

Trial Locations

Locations (4)

Omega Research Orlando LLC; 🇺🇸 Orlando, Florida, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

New Zealand Clinical Research Christchurch; 🇳🇿 Christchurch, New Zealand