Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LY3015014 IV
LY3015014 · 3 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.
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). |
| 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...
Top 12 of 15 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 4 | PHASE3 | Enlicitide |
| Novartis AG Sponsored ADR | NVS | 14 | PHASE3 | Inclisiran, Pelacarsen, DII235, QCZ484 |
| AstraZeneca PLC | AZN | 3 | PHASE3 | AZD0780, Laroprovstat, Rosuvastatin |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 5 | PHASE3 | Plozasiran, zodasiran, VSA003 |
| Ionis Pharmaceuticals, Inc. | IONS | 2 | PHASE3 | Olezarsen, ION775 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE2 | Alirocumab |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Solbinsiran |
| MediciNova, Inc. | MNOV | 1 | PHASE2 | MN-001 |
| Verve Therapeutics, Inc. | VERV | 4 | PHASE2 | VERVE-102, VERVE-201 |
| NewAmsterdam Pharma Company N.V. | NAMS | 1 | PHASE1 | Obicetrapib |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
| Esperion Therapeutics, Inc. | ESPR | 1 | - | Bempedoic acid+ Ezetimibe |
LY3015014 is being developed for hypercholesterolemia and hyperlipidemia, conditions marked by elevated cholesterol and lipids in the blood. It is an investigational small molecule studied in adults with high cholesterol. Eli Lilly and Company is the developer.
LY3015014 is developed by Eli Lilly and Company, which trades under the ticker LLY. Lilly sponsored the clinical program evaluating the drug in participants with high cholesterol and elevated low density lipoprotein cholesterol.
LY3015014 is in Phase 2 development. It is investigational and has not been approved for any indication. The Phase 2 study in hypercholesterolemia has been completed, and the program includes completed Phase 1 studies as well.
LY3015014 has been studied in three completed trials: NCT01890967, a Phase 2 study in 527 participants with hypercholesterolemia across the United States, Canada, Czechia, Denmark, Japan, Netherlands, Poland, and Puerto Rico; NCT01671085, a Phase 1 study in 13 healthy participants; and NCT01426412, a Phase 1 study in 69 healthy participants with elevated LDL cholesterol.
Yes, LY3015014 IV is an alternative name for LY3015014. Both refer to the same investigational small molecule developed by Eli Lilly and Company for hypercholesterolemia and hyperlipidemia.
The LY3015014 trials were randomized, double-blind, and placebo-controlled. The Phase 2 study NCT01890967 enrolled 527 adults with hypercholesterolemia, while the Phase 1 studies NCT01671085 and NCT01426412 enrolled healthy adults with high cholesterol or elevated LDL cholesterol. All three trials are completed.