A Study of LY3113593 in Participants With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
This study is not intended to treat anemia of chronic kidney disease but to determine the safety of the study drug, LY3113593. The study will also evaluate how much of the study drug gets into the blood stream, how long it takes the body to remove the study drug, and what effect the study drug has on the body. The study consists of up to three parts. Participants may only enroll in one part. Participants will receive up to four injections of LY3113593 or placebo into a vein. The study will last up to about 26 weeks including screening and follow-up.

Official Title
-----------------
A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3113593 in Patients Receiving Hemodialysis

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: LY3113593
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving hemodialysis regularly (at least 3 times per week) for at least 4 months Have a hemoglobin value (taken prior to dialysis, if taken on a dialysis day) greater than or equal to 9.5 grams per deciliter (g/dL) and less than or equal to 11.0 g/dL at screening Have been receiving erythropoiesis stimulating agent (ESA) injections for at least 4 weeks and are willing to stop the injections for approximately 8 weeks Exclusion Criteria: Have another health condition that may put the participant at risk or that the study doctor feels would make the participant unsuitable for the study Currently taking part in another study Have recently (within 30 days) completed a study or have previously taken part in this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3113593<br>Escalating doses of LY3113593 administered by intravenous (IV) infusion once every 4 weeks (Q4W) on (Day 1 and 29) in part A. | Drug: LY3113593<br>* Administered by slow intravenous (IV) infusion.<br>|
| Placebo Comparator: Placebo<br>0.9% saline, administered by intravenous (IV) infusion once Q4W (Day 1 and 29) in part A. | Drug: Placebo<br>* Administered by slow intravenous (IV) infusion.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of other non-serious adverse events (AEs) and all serious adverse events, regardless of causality, is located in the reported adverse events section. | Baseline through Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593 |  | Predose; 0.5, 4 hours post-dose | 
| PK: Area Under the Concentration Versus Time (AUCτ) | Area under the concentration versus time (AUCτ) is the AUC over the dosing interval (Q4W) | Predose; 0.5, 4 hours post-dose | 
| Pharmacodynamics (PD): Change From Baseline to Week 8 in Hemoglobin (Hb) |  | Predose; 0.5, 4 hours post-dose | 
| Number of Participants With Anti-LY3113593 Antibodies Detection | Participants with a detection of anti-LY3113593 antibodies at baseline and post-baseline time point at the following levels of 1:20, 1:40 or 1:80 titer. | Day 1: Predose; Day 15, 29, 57, 85 and 113 |