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

NCT07165015 | Completed Phase 1 FDA Drug

• 2 other identifiers: 27393J2S-MC-GZMM
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 4

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.

Conditions

End Stage Renal Disease (ESRD); Renal Impairment; Healthy; Renal Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

LY3537031 (Group 1)

EXPERIMENTAL

LY3537031 administered subcutaneously (SC) in a control group of participants with normal renal function

Drug: LY3537031

LY3537031 (Groups 2-3)

EXPERIMENTAL

LY3537031 administered SC in groups of participants with impaired renal function

Drug: LY3537031

LY3537031 (Group 3)

EXPERIMENTAL

LY3537031 administered SC in a group of participants with end-stage renal disease (ESRD) on hemodialysis

Drug: LY3537031

Interventions

LY3537031 DRUG

Administered SC

LY3537031 (Group 1); LY3537031 (Group 3); LY3537031 (Groups 2-3)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

Omega Research Orlando LLC

Orlando, Florida, 32808, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202-5188, United States

Location

New Zealand Clinical Research Christchurch

Christchurch, New Zealand

Location

Related Links

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

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: September 18, 2025
• Primary Completion: April 16, 2026
• Study Completion: April 16, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); NZ (1)