Recruiting

LY3537982 Dosing in Renal Impairment

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

LY3537982

Drug
Who is being recruted

Urogenital Diseases+4

+ Female Urogenital Diseases and Pregnancy Complications

+ Kidney Diseases

From 18 to 85 Years
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 1
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts
Last updated: December 19, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: August 18, 2025

Actual date on which the first participant was enrolled.

The study aims to find the correct dose of a new drug, LY3537982, for people who have kidney problems, especially those with severe kidney issues. Understanding the right amount of medication for these individuals is crucial because kidney problems can affect how the body processes drugs. This research could help ensure that people with kidney impairments receive effective and safe dosages, which is important for improving treatment outcomes and minimizing potential risks. Participants in the study will take a single dose of LY3537982. The study lasts about 43 days for each person involved. Researchers will closely monitor how the drug behaves in the body, particularly focusing on how kidneys with different levels of function handle the medication. This involves measuring the drug levels in the body over time to see how it is absorbed, distributed, and eliminated, helping to determine the best dosage for those with varying kidney functions.

Official TitlePharmacokinetics of LY3537982 Following a Single Dose in Participants With Renal Impairment Compared With Participants With Normal Renal Function 
NCT07137689
Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts
Last updated: December 19, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic DiseasesRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
LY3537982 administered orally.

Group II

Experimental
LY3537982 administered orally.

Group III

Experimental
LY3537982 administered orally.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Recruiting

Jacksonville Center for Clinical Research

Jacksonville, United StatesSee the location
Recruiting

Panax Clinical Research

Miami Lakes, United States
Recruiting

Orlando Clinical Research Center

Orlando, United States
Recruiting

Genesis Clinical Research

Tampa, United States
Recruiting
4 Study Centers