Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3015014 · 4 trials · 3 indications
Least square (LS) Means was calculated using analysis of covariance (ANCOVA) adjusted for disease classification, statin dose, baseline LDL-C measurement. Percent change from baseline response is the dependent variable.
Events deemed to be SAEs by the Investigator as related to study drug administration were collected during the study and 30 days following study drug administration. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
TEAEs were defined as SAEs and other non-serious AEs that occurred or worsened after study treatment. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section of this report.
Adverse events (AEs) were considered as clinically significant effects. A summary of serious AEs (SAEs) and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| 20 mg LY3015014 Q4W | EXPERIMENTAL | 20 milligrams (mg) LY3015014 given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. |
| 120 mg LY3015014 Q4W | EXPERIMENTAL | 120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. |
| 300 mg LY3015014 Q4W | EXPERIMENTAL | 300 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. |
| 100 mg LY3015014 Q8W | EXPERIMENTAL | 100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. |
| 300 mg LY3015014 Q8W | EXPERIMENTAL | 300 mg LY3015014 given SC Q8W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. |
| Placebo Q4W | PLACEBO_COMPARATOR | Placebo given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. |
| 1.0 milligrams per kilogram (mg/kg) of LY3015014 | EXPERIMENTAL | 1.0 mg/kg of LY3015014 given subcutaneously (SQ) on 2 dosing occasions occurring 4 weeks apart (Q4W) (Days 1 and 29). |
| Placebo | PLACEBO_COMPARATOR | 0.9% sodium chloride injection given SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29). |
| 1.0 milligrams per kilogram (mg/kg) LY3015014 Every 2 Weeks | EXPERIMENTAL | 1.0 mg/kg LY3015014 given subcutaneously (SC) once every 2 weeks for 29 days. |
| 1.0 mg/kg LY3015014 Every 4 Weeks | EXPERIMENTAL | 1.0 mg/kg LY3015014 given SC once every 4 weeks for 29 days. |
| 3.0 mg/kg LY3015014 Every 2 Weeks | EXPERIMENTAL | 3.0 mg/kg LY3015014 given SC once every 2 weeks for 29 days. |
| 3.0 mg/kg LY3015014 Every 4 Weeks | EXPERIMENTAL | 3.0 mg/kg LY3015014 given SC once every 4 weeks for 29 days. |
| Placebo Every 2 Weeks | PLACEBO_COMPARATOR | Saline injection (to match LY3015014) given SC once every 2 weeks for 29 days. |
| Placebo Every 4 Weeks | PLACEBO_COMPARATOR | Saline injection (to match LY3015014) given SC once every 4 weeks for 29 days. |
| LY3015014 intravenously (IV) | EXPERIMENTAL | A single dose of LY3015014 up to 10.0 milligrams per kilogram (mg/kg) administered IV |
| LY3015014 IV Japanese | EXPERIMENTAL | Single dose of LY3015014 10.0 mg/kg administered IV to Japanese participants. Added per protocol amendment effective October, 2012. |
| Placebo IV | PLACEBO_COMPARATOR | Administered IV once only |
| LY3015014 subcutaneously (SC) | EXPERIMENTAL | A single dose of LY3015014 up to 3.0 mg/kg administered SC |
| LY3015014 SC + Statin | EXPERIMENTAL | A single dose of LY3015014 up to 3 mg/kg administered SC in addition to participant's dose of statin |
| Placebo SC | PLACEBO_COMPARATOR | Administered SC once only |
| Name | Type | Description |
|---|---|---|
| LY3015014 | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| Statin | DRUG | Administered orally |
| Ezetimibe | DRUG | Administered orally |
| LY3015014 IV | DRUG | Administered IV over 30-90 minutes |
| Placebo IV | DRUG | Administered IV only over 30-90 minutes |
| LY3015014 SC | DRUG | Administered SC |
| Placebo SC | DRUG | Administered SC |
Inclusion Criteria: * Diagnosed with high low density lipoprotein (LDL) cholesterol * Are on stable daily dose of a statin or have a history of statin intolerance * Men with a partner who can become pregnant must agree to use barrier protection during sexual intercourse to prevent pregnancies * Wom...
LY3015014 is an investigational small molecule being studied for use in hyperlipidemia and hypercholesterolemia, conditions involving elevated lipid and cholesterol levels. It has also been evaluated in healthy volunteers. The drug is being developed by Eli Lilly and Company and is currently in clinical development, though it is not approved.
LY3015014 is a small molecule, but its specific molecular target has not been disclosed in available information. It is being studied for its effects on lipid and cholesterol levels in conditions such as hyperlipidemia and hypercholesterolemia. The drug's mechanism of action is not publicly detailed.
LY3015014 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 metabolic conditions, and it is not yet approved for any use.
LY3015014 is in Phase 1 clinical development. It has completed multiple Phase 1 trials in healthy volunteers and participants with elevated cholesterol. The drug is investigational and has not received FDA approval. Its development status reflects early-stage testing for safety and tolerability.
LY3015014 has completed several clinical trials, including NCT01426412, NCT01618916, and NCT01671085, all Phase 1 studies in healthy participants with elevated LDL cholesterol or high cholesterol. These trials were conducted in the United States and have been completed. The drug is no longer in active trials.
LY3015014 is not known to have any alternative names. It is a distinct investigational small molecule developed by Eli Lilly and Company. No other names or aliases for this drug have been identified in available information.