LY3537982 Dosing in Renal Impairment
LY3537982
Urogenital Diseases+4
+ Female Urogenital Diseases and Pregnancy Complications
+ Kidney Diseases
Basic Science Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy 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
Panax Clinical Research
Miami Lakes, United StatesOrlando Clinical Research Center
Orlando, United StatesGenesis Clinical Research
Tampa, United States