A Study of LY3015014 in Participants With High Cholesterol
Summary
This study is designed to define the amount and duration of cholesterol lowering and to assess the safety and tolerability of different dose regimens of LY3015014 in participants with high cholesterol. The study will also investigate how the body processes the drug and how the drug affects the body. Participants will remain on a stable diet and will continue taking cholesterol-lowering medications (statins with or without ezetimibe). After signing the informed consent document, the participant will complete a screening/run-in period that will last at most 8 weeks. Then, the treatment period will last approximately 16 weeks. After the treatment period, the participants will complete a follow-up period lasting approximately 8 weeks for a total study duration ranging from approximately 25 to 32 weeks.
Timeline
- Start
- 2013-06
- Primary completion
- 2014-04
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FROVOCIMAB | Monoclonal antibody | 20 mg | Subcutaneous |
| Subject | FROVOCIMAB | Monoclonal antibody | 100 mg | Subcutaneous |
| Subject | FROVOCIMAB | Monoclonal antibody | 120 mg | Subcutaneous |
| Subject | FROVOCIMAB | Monoclonal antibody | 300 mg | Subcutaneous |
| Background | Atorvastatin | Small molecule | — | Oral |
| Background | Ezetimibe | Unknown | — | Oral |
| Background | Fluvastatin | Other / unclassified | — | Oral |
| Background | Lovastatin | Small molecule | — | Oral |
| Background | Pitavastatin | Small molecule | — | Oral |
| Background | Pravastatin | Small molecule | — | Oral |
| Background | Rosuvastatin | Small molecule | — | Oral |
| Background | Simvastatin | Small molecule | — | Oral |