Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01890967 | A Study of LY3015014 in Participants With High Cholesterol | PHASE2 | COMPLETED | 527 | — | — | Jun 1, 2013 | Jun 1, 2014 | Sep 18, 2019 | 49 | United States, Canada +6 |
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.
| 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. |
| Name | Type | Description |
|---|---|---|
| LY3015014 | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| Statin | DRUG | Administered orally |
| Ezetimibe | DRUG | Administered orally |
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...