Completed

A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3113593 in Healthy Subjects and Patients With Chronic Kidney Disease Treated With Hemodialysis

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What is being tested

LY3113593

+ Placebo

Drug
Who is being recruted

Urogenital Diseases+10

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

Over 18 Years
See all eligibility criteria
How is the trial designed

Other Study

Placebo-ControlledPhase 1
Interventional
Study Start: June 2014
See protocol details

Summary

Principal SponsorEli Lilly and Company
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2014

Actual date on which the first participant was enrolled.

The purpose of this study is to look at the tolerability and safety of LY3113593. Study doctors will see how safe it is and whether it produces side effects following a single injection into a vein or under the skin in healthy participants (Part A) and participants with chronic kidney disease treated with hemodialysis (Part B). The study will also measure how much of the study drug gets into the blood stream, how long it takes the body to get rid of the study drug and what effects the study drug has on the body. This is the first time that this study drug is being given to participants. This study is for research purposes only and is not intended to treat any medical condition. For each participant, the study will last about 85 days, not including screening. Screening is required within 28 days prior to the start of the study.

Official TitleA Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3113593 in Healthy Subjects and Patients With Chronic Kidney Disease Treated With Hemodialysis
NCT02144285
Principal SponsorEli Lilly and Company
Last updated: January 27, 2026
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

64 patients to be enrolled

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

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



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.

Over 18 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 DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney Failure, ChronicPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

Inclusion Criteria: * Healthy Participants: * Healthy males or females * Participants have a body mass index (BMI) of 18.5 to 29.9 kilogram per meter square (kg/m\^2), inclusive at screening * Participants Treated with Hemodialysis: * Participants are males or females who have end-stage renal disease (ESRD) and have been receiving adequate maintenance hemodialysis (3 times weekly) for at least 12 weeks prior to screening * Participants have a hemoglobin value greater than or equal to (≥)9.0 grams per deciliter (g/dL) and less than or equal to (≤)12.5 g/dL at screening * Participants have a body mass index (BMI) of 18.5 to 45.0 kg/m\^2, inclusive, at screening * Both Populations: * Male participants agree to use a reliable method of birth control and avoid donating sperm during the study and for 3 months following the dose of the investigational product * Female participants must not be of child-bearing potential Exclusion Criteria: * Healthy Participants: * Participants that have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data * Participants that have used or intend to use over-the-counter or prescription medication, including herbal medications within 14 days prior to dosing * Participants Treated with Hemodialysis: * Participants that have a history of myocardial infarction, acute coronary syndrome, stroke or transient ischemic attacks within the prior 6 months * Participants that have heart failure that results in dyspnea at rest or during minimal exercise * Participants that have poorly controlled hypertension * Participants that have a history of significant thrombotic disease, pulmonary hypertension, significant hematological disease or current liver disease, known hepatic or biliary abnormalities * Participants that had a blood transfusion within the prior 12 weeks or an anticipated need for blood transfusion during the study * Participants that have evidence of active peptic, duodenal, or esophageal ulcer disease or gastrointestinal bleeding within the prior 12 weeks * Both Populations: * Participants that have known allergies to related compounds or any components of the study drug or its formulation, clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions or history of significant atopy * Participants that have participated, within the last 30 days (or 5 half-lives if long half life) in a clinical trial involving an investigational product * Participants that have known or ongoing psychiatric disorders

Study Plan

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

6 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Single dose of LY3113593 administered intravenous (IV) at a minimum of six dose levels

Group II

Experimental
Single dose of LY3113593 administered IV

Group III

Experimental
Single dose of LY3113593 administered subcutaneous (SC)

Group IV

Placebo
Single dose of placebo matching LY3113593 administered IV

Group 5

Placebo
Single dose of placebo matching LY3113593 administered IV

Group 6

Placebo
Single dose of placebo matching LY3113593 administered SC

Study Objectives

Primary Objectives

Secondary 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 3 locations

Suspended

Parexel Early Phase Unit at Glendale

Glendale, United StatesOpen Parexel Early Phase Unit at Glendale in Google Maps
Suspended

Orlando Clinical Research Center

Orlando, United States
Suspended

Davita Clinical Research

Minneapolis, United States
Completed3 Study Centers