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

Renal Insufficiency

From 18 to 85 Years
+17 Eligibility Criteria

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) or
Last updated: October 20, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 18, 2025Actual 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 
Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Last updated: October 20, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 85 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Renal Insufficiency
Criteria
6 inclusion criteria required to participate
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

Show More Criteria

11 exclusion criteria prevent from participating
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

Show More Criteria

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 ResearchJacksonville, United StatesSee the location
Recruiting
Panax Clinical ResearchMiami Lakes, United States
Recruiting
Orlando Clinical Research CenterOrlando, United States
Recruiting
Genesis Clinical ResearchTampa, United States
Recruiting
4 Study Centers