Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bococizumab · 8 trials · 3 indications
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
AUCinf is the area under the plasma concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.
Maximum observed concentration.
| Arm | Type | Description |
|---|---|---|
| Bococizumab 150mg | EXPERIMENTAL | Bococizumab 150mg autoinjector (pre-filled pen) |
| Bococizumab 75mg | EXPERIMENTAL | Bococizumab 75mg autoinjector (pre-filled pen) |
| Bococizumab 150mg placebo | PLACEBO_COMPARATOR | Bococizumab 150mg placebo autoinjector (pre-filled pen) |
| Bococizumab 75mg placebo | PLACEBO_COMPARATOR | Bococizumab 75mg autoinjector (pre-filled pen) |
| Bococizumab (PF-04950615; RN316) | EXPERIMENTAL | Bococizumab (PF-04950615; RN316) |
| placebo | PLACEBO_COMPARATOR | - |
| Bococizumab (PF-04950615;RN316) | EXPERIMENTAL | Bococizumab (PF-04950615;RN316) |
| Atorvastatin | ACTIVE_COMPARATOR | - |
| Population A | EXPERIMENTAL | A total of 9 groups in two population. Population A comprises hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin. A subject who is receiving a stable dose of atorvastatin will be randomized into one out of 5 dose groups. |
| Population B | EXPERIMENTAL | A total of 9 groups in two population. Population B comprises hypercholesterolemic Japanese subjects who are naïve for a treatment by lipid lowering drug and whose fasting LDL-cholesterol is not controlled. A subject who is treatment naïve will be randomized into one out of 4 dose groups. |
| Single 150 mg PF-04950615 dose administered to the abdomen | ACTIVE_COMPARATOR | - |
| Single 150 mg PF-04950615 dose administered to the upper arm | EXPERIMENTAL | - |
| Single 150 mg PF-04950615 dose administered to the thigh | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bococizumab 150mg | BIOLOGICAL | Bococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection. |
| Bococizumab 75mg | BIOLOGICAL | Bococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection. |
| Bococizumab 150mg placebo | BIOLOGICAL | Bococizumab placebo autoinjector (pre-filled pen) combination Product. 150mg placebo every 2 weeks for 10 weeks, subcutaneous injection. |
| Bococizumab 75mg placebo | BIOLOGICAL | Bococizumab placebo autoinjector (pre-filled pen) combination product. 75mg placebo every 2 weeks for 10 weeks, subcutaneous injection. |
| Bococizumab (PF-04950615; RN316) | DRUG | 150 mg every 2 weeks, subcutaneous injection for 52 weeks. |
| Placebo | OTHER | Subcutaneous injection every 2 weeks for 52 weeks. |
| Bococizumab (PF-04950615;RN316) | DRUG | 150 mg every 2 weeks by subcutaneous injection for 24 weeks |
| Atorvastatin | DRUG | Atorvastatin PO QD |
| Placebo for Bococizumab (PF-04950615;RN316) | OTHER | 150 mg every 2 weeks by subcutaneous injection for 24 weeks |
| Placebo for atorvastatin | OTHER | PO QD |
| Ezetimibe | DRUG | Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open) |
Inclusion Criteria: * Treated with a statin - Fasting LDL-C \>=70mg/dL and triglycerides \<=400mg/dL Exclusion Criteria: * Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or procedures during the past 90 days - Congestive heart failure NYHA class IV - Poorly controlled...
Bococizumab is an investigational drug being studied for hyperlipidemia, heterozygous familial hypercholesterolemia, and hypercholesterolemia. It is a small molecule being developed by Pfizer, Inc. for metabolic conditions. As of the available data, it is in Phase 3 clinical development and has not been approved by the FDA.
The specific molecular target of Bococizumab is not disclosed in the available information. It is being studied for its effects on lipid levels in conditions such as hyperlipidemia and hypercholesterolemia, but the exact mechanism of action has not been specified.
Bococizumab is being developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the drug's safety and efficacy in patients with lipid disorders.
Bococizumab is in Phase 3 clinical development. It has completed five clinical trials, including Phase 1, Phase 2, and Phase 3 studies. However, it remains investigational and is not FDA approved. The drug is not currently in any active trials, as all five studies have been completed.
Bococizumab has completed five clinical trials. Key studies include NCT01968967, a Phase 3 trial in hyperlipidemia with 2,139 participants, and NCT01968980, a Phase 3 trial in heterozygous familial hypercholesterolemia with 370 participants. Other trials include NCT02043301 (Phase 1) and NCT02055976 (Phase 2).
Yes, Bococizumab is also known as PF-04950615 and RN316. These alternative names appear in clinical trial records, such as NCT01968967, which refers to Bococizumab (PF-04950615; RN316). Researchers and investors may encounter these names when searching for information about the drug.