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OpenTrials
Completed

NCT Number: NCT07165015

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Zealand Clinical Research Christchurch, Christchurch, New Zealand

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3537031

Drug

Administered SC

Primary outcomes

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

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

    PK: AUC of LY3537031

  2. PK: Maximum Concentration (Cmax) of LY3537031

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

    PK: Cmax of LY3537031

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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