Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2928057 · 1 trial · 2 indications
A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.
| Arm | Type | Description |
|---|---|---|
| LY2928057 (No ESA) | EXPERIMENTAL | Multiple doses of LY2928057 administered intravenously (IV) either once every 2 weeks (Q2W) or once per week (QW) for 6 weeks. Participants discontinued their personal physician-prescribed erythropoiesis stimulating agent (ESA) before treatment. |
| LY2928057 (Reduced ESA) | EXPERIMENTAL | Multiple doses of LY2928057 administered IV either Q2W or QW for 6 weeks. Participants reduced their personal physician-prescribed ESA dose before treatment. |
| Placebo (No ESA) | PLACEBO_COMPARATOR | Multiple doses of placebo administered IV either Q2W or QW for 6 weeks. Participants discontinued their personal physician-prescribed ESA dose before treatment. |
| Placebo (Reduced ESA) | PLACEBO_COMPARATOR | Multiple doses of placebo administered IV either Q2W or QW for 6 weeks. Participants reduced their personal physician-prescribed ESA dose before treatment. |
| Name | Type | Description |
|---|---|---|
| LY2928057 | DRUG | Administered intravenously |
| Placebo | DRUG | Administered intravenously |
Inclusion Criteria: * Participants having end-stage renal disease (ESRD), have received an erythropoiesis stimulating agent (ESA) at least weekly for 2 weeks prior to screening, and have been receiving adequate maintenance hemodialysis (3 times weekly) for at least 12 weeks prior to screening (that...
LY2928057 is an investigational small molecule developed by Eli Lilly and Company for chronic renal insufficiency, also called chronic kidney disease. It has been studied in a Phase 1 clinical trial in people receiving hemodialysis. It is not an approved medicine and remains in clinical development.
LY2928057 was studied for use in chronic renal insufficiency, or chronic kidney disease, specifically in participants undergoing hemodialysis. The research was early stage, so no approved use has been established. It is an investigational therapy rather than a marketed treatment for kidney disease.
LY2928057 is made and developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 1 study of the compound in hemodialysis participants conducted in the United States.
LY2928057 is in Phase 1 clinical development. Its single recorded trial, NCT01991483, was a completed Phase 1 study. The drug is investigational and has not been approved by the FDA for any indication.
LY2928057 has been evaluated in one clinical trial, NCT01991483, titled A Study of LY2928057 in Hemodialysis Participants. That Phase 1 trial enrolled 28 adults aged 18 and older, was randomized, double blind, and placebo controlled, and took place in the United States. It is now completed.