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 Was the medicine not flowing after needle withdrawn?"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 Was the medicine not flowing after needle withdrawn?"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 Was the medicine not flowing after needle withdrawn?"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 Was the medicine not flowing after needle withdrawn?"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 Was the medicine not flowing after needle withdrawn?"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 Was the medicine not flowing after needle withdrawn?"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 monoclonal antibody developed by Pfizer for lowering cholesterol in people with hyperlipidemia, hypercholesterolemia, and heterozygous familial hypercholesterolemia. It was studied in Phase 3 clinical trials as an injectable therapy for patients who need additional lipid lowering beyond standard treatment.
Bococizumab was being developed to treat heterozygous familial hypercholesterolemia, hypercholesterolemia, and hyperlipidemia, including in patients who are intolerant to statins. It was studied as a cholesterol-lowering treatment in adults at risk of cardiovascular events, but it remains investigational and is not an approved therapy.
Bococizumab targets PCSK9, a protein that regulates cholesterol clearance from the blood. As a PCSK9 inhibitor, this monoclonal antibody binds PCSK9 to reduce its effect on LDL receptor recycling, which is intended to lower LDL cholesterol levels in patients with hyperlipidemia.
Bococizumab is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical development program, including the Phase 3 trials that evaluated the drug in patients with hyperlipidemia and related cholesterol disorders.
Bococizumab is in Phase 3 development and is investigational. It has not been approved by the FDA. Five clinical trials have been completed, including Phase 2 and Phase 3 studies, with no active trials currently listed in its development program.
Completed Bococizumab trials include NCT02458287, an autoinjector use study in hyperlipidemia; NCT02135029, in statin-intolerant patients; NCT02100514, in primary hyperlipidemia or mixed dyslipidemia; and NCT02055976, a Phase 2 dose-ranging study in Japanese subjects with hypercholesterolemia. These trials enrolled more than 4,000 participants combined.
Yes. Bococizumab is also known as PF-04950615 and RN316, and it has been referenced as Bococizumab 150mg. These are alternative names and identifiers for the same Pfizer monoclonal antibody, so searches using PF-04950615 or RN316 refer to the same investigational PCSK9 inhibitor.