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...
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LY3113593 is an investigational small molecule being developed by Eli Lilly and Company for chronic kidney disease and chronic kidney failure. It is currently in Phase 1 clinical development and has not been approved by the FDA. Two Phase 1 trials have been completed, one in healthy participants and those with chronic kidney disease on hemodialysis, and another in participants with chronic kidney disease.
LY3113593 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol 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 drug and has not been approved by the FDA. Two Phase 1 trials have been completed, one enrolling 64 participants and the other enrolling 7 participants, both in the United States.
LY3113593 has completed two Phase 1 clinical trials. The first, NCT02144285, studied the drug in healthy participants and participants with chronic kidney disease treated with hemodialysis, enrolling 64 participants. The second, NCT02604160, studied the drug in participants with chronic kidney disease, enrolling 7 participants. Both trials were conducted in the United States.
LY3113593 is not FDA approved. It is an investigational small molecule currently in Phase 1 clinical development for chronic kidney disease and chronic kidney failure. Two Phase 1 trials have been completed, but the drug has not yet progressed to later stages of clinical testing or received regulatory approval.