Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3113593 · 2 trials · 2 indications
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.
The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
| Arm | Type | Description |
|---|---|---|
| LY3113593 | EXPERIMENTAL | Escalating doses of LY3113593 administered by intravenous (IV) infusion once every 4 weeks (Q4W) on (Day 1 and 29) in part A. |
| Placebo | PLACEBO_COMPARATOR | 0.9% saline, administered by intravenous (IV) infusion once Q4W (Day 1 and 29) in part A. |
| LY3113593 IV (Part A) | EXPERIMENTAL | Single dose of LY3113593 administered intravenous (IV) at a minimum of six dose levels |
| Placebo IV (Part A) | PLACEBO_COMPARATOR | Single dose of placebo matching LY3113593 administered IV |
| LY3113593 SC (Part A) | EXPERIMENTAL | Single dose of LY3113593 administered subcutaneous (SC) |
| Placebo SC (Part A) | PLACEBO_COMPARATOR | Single dose of placebo matching LY3113593 administered SC |
| LY3113593 IV (Part B) | EXPERIMENTAL | Single dose of LY3113593 administered IV |
| Placebo IV (Part B) | PLACEBO_COMPARATOR | Single dose of placebo matching LY3113593 administered IV |
| Name | Type | Description |
|---|---|---|
| LY3113593 | DRUG | Administered by slow intravenous (IV) infusion. |
| Placebo | DRUG | Administered by slow intravenous (IV) infusion. |
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 be...
Top 20 of 25 competitors
LY3113593 is an investigational small molecule being studied for kidney failure, chronic, and chronic kidney disease. It is in Phase 1 clinical development by Eli Lilly and Company. The drug is not approved and remains under investigation for these nephrology conditions.
LY3113593 is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the NYSE under the ticker LLY. The drug is an investigational small molecule in Phase 1 clinical development for chronic kidney disease and chronic kidney failure.
LY3113593 is in Phase 1 clinical development. It is an investigational small molecule being studied for chronic kidney disease and chronic kidney failure. The drug is not FDA approved and remains under clinical investigation.
LY3113593 has been studied in two completed Phase 1 clinical trials. NCT02144285 enrolled 64 participants, including healthy volunteers and those with chronic kidney disease on hemodialysis. NCT02604160 enrolled 7 participants with chronic kidney disease. Both trials were conducted in the United States.
LY3113593 is the primary identifier for this investigational drug. No alternative names have been reported for this Eli Lilly and Company small molecule being studied in chronic kidney disease and chronic kidney failure.