A Study of LY3537982 in Participants With Kidney Problems Compared With Participants With Normal Kidney Function
NCT ID: NCT07137689
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
2025-08-18
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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LY3537982 (Normal renal function)
LY3537982 administered orally.
LY3537982
Administered orally
LY3537982 (Severe renal impairment)
LY3537982 administered orally.
LY3537982
Administered orally
LY3537982 (Moderate renal impairment)
LY3537982 administered orally.
LY3537982
Administered orally
Interventions
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LY3537982
Administered orally
Eligibility Criteria
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Inclusion Criteria
* Participants Assigned Male at Birth (AMAB) who agree to follow contraception guidance or participants AFAB who are individuals of childbearing potential (INOCBP).
* Severe renal impairment: Have eGFR determined by CKD-EPI of less than 30 mL/min and not requiring dialysis.
* Moderate renal impairment: Have eGFR determined by CKD-EPI of greater than or equal to 30 mL/min and less than 60 mL/min.
* Are not currently or have not previously been on hemodialysis, including peritoneal dialysis.
* Have acceptable blood pressure as defined by systolic blood pressure less than 160 mmHg and diastolic blood pressure less than 95 mmHg, as well as acceptable pulse rate as defined by no less than 50 bpm and no greater than 100 bpm
Exclusion Criteria
\* ALT or AST greater than 2.5 × ULN without any increase in TBL or \* TBL greater than 1.5 × ULN without any increase in aminotransferase.
* Have a current, functional renal transplant. Non-functional renal allografts may be allowed if failure has been greater than 1 year and no longer on immunosuppressive therapies.
* Diagnosed and/or treated malignancy within 5 years prior to screening with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and curatively resected in situ carcinoma of the cervix
* Have known allergies to LY3537982, related compounds or any components of the formulation, or a history of significant atopy.
* Have previously completed or withdrawn from this study or any other study investigating LY3537982.
* Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days, whichever is longer should have passed, prior to admission
* Show evidence of HIV infection or positive human HIV antibodies.
* Have evidence of hepatitis B at screening, that is, positive test for hepatitis B surface antigen, HBV DNA, or both.
* Have a positive hepatitis C antibody test. Participants with a positive hepatitis C antibody test at screening can be included only if a confirmatory HCV RNA test is negative.
* Are participants AFAB with a positive pregnancy test or who are lactating. ssion onward, up to 2 g per day of acetaminophen will be allowed at the discretion of the investigator.
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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Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Genesis Clinical Research
Tampa, Florida, United States
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]
Other Identifiers
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J3M-OX-JZQG
Identifier Type: OTHER
Identifier Source: secondary_id
18678
Identifier Type: -
Identifier Source: org_study_id