A Study of LY3537982 in Participants With Kidney Problems Compared With Participants With Normal Kidney Function

NCT07137689 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18678J3M-OX-JZQG
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Renal Insufficiency

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics: Maximum Concentration (Cmax) of LY3537982

  Day 1, Predose up to Day 5 Postdose

• Pharmacokinetics: Area Under the Concentration Verses Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3537982

  Day 1, Predose up to Day 5 Postdose

• Pharmacokinetics: Area Under the Concentrations Verses Time Curve from Time Zero to Time t (AUC(0-tlast) of LY3537982

  Day 1, Predose up to Day 5 Postdose

Study Arms (3)

LY3537982 (Normal renal function)

EXPERIMENTAL

LY3537982 administered orally.

Drug: LY3537982

LY3537982 (Severe renal impairment)

EXPERIMENTAL

LY3537982 administered orally.

Drug: LY3537982

LY3537982 (Moderate renal impairment)

EXPERIMENTAL

LY3537982 administered orally.

Drug: LY3537982

Interventions

LY3537982 DRUG

Administered orally

LY3537982 (Moderate renal impairment); LY3537982 (Normal renal function); LY3537982 (Severe renal impairment)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Genesis Clinical Research

Tampa, Florida, 33603, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: August 22, 2025
• Study Start: August 18, 2025
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)