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CompletedNCT07165015Updated Apr 24, 2026

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

A Phase 1 interventional study of LY3537031 in Renal Impairment, Healthy and Renal Insufficiency, sponsored by Eli Lilly and Company. Completed at 4 sites in 2 countries. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
31
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Impairment
  • Healthy
  • Renal Insufficiency
  • End Stage Renal Disease (ESRD)
03

In context

Renal Insufficiency

1,994 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 31 is below the median of 43 across 1,503 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts 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

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    LY3537031 (Group 1)

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

    Drug: LY3537031

  • Experimental
    LY3537031 (Groups 2-3)

    LY3537031 administered SC in groups of participants with impaired renal function

    Drug: LY3537031

  • Experimental
    LY3537031 (Group 3)

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

    Drug: LY3537031

Interventions

  • DrugLY3537031

    Administered SC

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537031

    PK: AUC of LY3537031

    Time frame: Predose on day 1 up to week 8 post dose

  2. PK: Maximum Concentration (Cmax) of LY3537031

    PK: Cmax of LY3537031

    Time frame: Predose on day 1 up to week 8 post dose

07

Study locations

4 sites
  • Omega Research Orlando LLC
    Orlando, Florida 32808, United States
  • Orlando Clinical Research Center
    Orlando, Florida 32809, United States
  • Indiana University School of Medicine
    Indianapolis, Indiana 46202-5188, United States
  • New Zealand Clinical Research Christchurch
    Christchurch, New Zealand
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07165015
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Sep 10, 2025
Start date
Sep 18, 2025
Primary completion
Apr 16, 2026
Completion
Apr 16, 2026
Last update
Apr 24, 2026

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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