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

Completed · Phase 1

Conditions studied: Renal Impairment, Healthy, Renal Insufficiency, End Stage Renal Disease (ESRD)

In brief

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.

Key facts

Study ID

NCT07165015

Run by

Eli Lilly and Company

People needed

31

Starts

2025-09-18

Expected to finish

2026-04-16

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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