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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-18

Study Completion Date

2026-03-31

Brief Summary

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The purpose of this study is to help determine the right dose of LY3537982 in participants with kidney problems, particularly those with severe kidney problems. The study will last about 43 days for each participant.

Detailed Description

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Conditions

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Renal Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3537982 (Normal renal function)

LY3537982 administered orally.

Group Type EXPERIMENTAL

LY3537982

Intervention Type DRUG

Administered orally

LY3537982 (Severe renal impairment)

LY3537982 administered orally.

Group Type EXPERIMENTAL

LY3537982

Intervention Type DRUG

Administered orally

LY3537982 (Moderate renal impairment)

LY3537982 administered orally.

Group Type EXPERIMENTAL

LY3537982

Intervention Type DRUG

Administered orally

Interventions

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LY3537982

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a body mass index (BMI) within the range 19.0 to 42.0 kilograms per square meter (kg/m²), inclusive.
* 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

* Have history of chronic liver disease, or any evidence for hepatic impairments, or

\* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Panax Clinical Research

Miami Lakes, Florida, United States

Site Status RECRUITING

Orlando Clinical Research Center

Orlando, Florida, United States

Site Status RECRUITING

Genesis Clinical Research

Tampa, Florida, United States

Site Status RECRUITING

Countries

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United States

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