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A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment | Clinical Trials | Clareo Health

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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

NCT07165015•Eli Lilly and Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Yes

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
•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
•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

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

Key Dates

Start Date

September 18, 2025

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

March 19, 2026

Enrollment

ESTIMATED participants

Conditions

Renal ImpairmentHealthyRenal InsufficiencyEnd Stage Renal Disease (ESRD)

Interventions

LY3537031

DRUG

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

NCT06290258

Autism Spectrum DisorderGastrointestinal Diseases+1 more

View study

RECRUITING

Collection of Data and Samples From Healthy Donors for Use in Translational Research

NCT00090662

Healthy Volunteer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

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