Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2928057 · 2 trials · 3 indications
A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.
A clinically significant effect/event was defined as an adverse event (AE). A listing of serious and non-serious AEs is located in the Reported Adverse Event Module.
| 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. |
| Placebo | PLACEBO_COMPARATOR | Single intravenous placebo dose. |
| 30 mg LY2928057 (Cohort 1) | EXPERIMENTAL | Day 1: single 30-milligram (mg) LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057. |
| 100 mg LY2928057 (Cohort 2) | EXPERIMENTAL | Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057. |
| 300 mg LY2928057 (Cohort 3) | EXPERIMENTAL | Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057. |
| 1000 mg LY2928057 (Cohort 4) | EXPERIMENTAL | Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057. |
| 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 being studied for use in chronic renal insufficiency, chronic kidney disease, and in healthy volunteers. It is being developed by Eli Lilly and Company and has completed Phase 1 clinical trials.
LY2928057 is a ferroportin antibody, meaning it targets ferroportin, a protein involved in iron transport. It is being studied for its effects in conditions related to chronic kidney disease and renal insufficiency.
LY2928057 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY.
LY2928057 is in Phase 1 clinical development. It has completed two Phase 1 trials, one in healthy volunteers and one in hemodialysis participants with chronic kidney disease. It is not yet approved and remains investigational.
LY2928057 has been studied in two completed Phase 1 trials. NCT01330953 was a first human study in healthy volunteers in Singapore, and NCT01991483 was a study in hemodialysis participants with chronic kidney disease in the United States.
Yes, LY2928057 is described as a ferroportin antibody. It is being investigated for its potential role in conditions involving iron metabolism, particularly in the context of chronic kidney disease and renal insufficiency.