NCT07165015CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 3 Sept 2025
- Start date
- 18 Sept 2025
- Primary completion date
- 16 Apr 2026
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Chronic kidney disease
- NCT number
- NCT07165015
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 31
- From 18 Sept 2025 to the primary completion date, 16 Apr 2026
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have a current, functional renal transplant. Non-functional renal allografts may be allowed
Other illness
- Have a history of chronic liver disease, acute or chronic hepatitis, including a history of autoimmune hepatitis, any evidence for hepatic impairments
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| New Zealand Clinical Research - Christchurch Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Indiana University School of Medicine Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Omega Research Orlando, LLC Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Orlando Clinical Research Center Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.