A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment
NCT ID: NCT07165015
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
32 participants
INTERVENTIONAL
2025-09-18
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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LY3537031 (Group 1)
LY3537031 administered subcutaneously (SC) in a control group of participants with normal renal function
LY3537031
Administered SC
LY3537031 (Groups 2-3)
LY3537031 administered SC in groups of participants with impaired renal function
LY3537031
Administered SC
LY3537031 (Group 3)
LY3537031 administered SC in a group of participants with end-stage renal disease (ESRD) on hemodialysis
LY3537031
Administered SC
Interventions
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LY3537031
Administered SC
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
85 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Related Links
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A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment
Other Identifiers
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J2S-MC-GZMM
Identifier Type: OTHER
Identifier Source: secondary_id
27393
Identifier Type: -
Identifier Source: org_study_id