Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects

Summary

The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C) lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two weeks (Q14D) in hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin, or who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled.

Timeline

Start

2014-03

Primary completion

2015-01

Completion

2015-01

Outcome

Met primary endpoint

registry Atorvastatin + PF-04950615 50 mg vs Atorvastatin + PF-04950615 Placebo; p <0.001; Adjusted Mean Difference -49.838 (95% CI -57.335 to -42.340) NCT02055976 ↗

registry Atorvastatin + PF-04950615 50 mg vs Atorvastatin + PF-04950615 Placebo; p <0.001; Adjusted Mean Difference -42.293 (95% CI -49.417 to -35.168) NCT02055976 ↗

Publications

• Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
• Yokote K, Suzuki A, Li Y, Matsuoka N, Teramoto T. Pharmacokinetics and exploratory efficacy biomarkers of bococizumab, an anti-PCSK9 monoclonal antibody, in hypercholesterolemic Japanese subjects . Int J Clin Pharmacol Ther. 2019 Dec;57(12):575-589. doi: 10.5414/CP203418.
• Yokote K, Kanada S, Matsuoka O, Sekino H, Imai K, Tabira J, Matsuoka N, Chaudhuri S, Teramoto T. Efficacy and Safety of Bococizumab (RN316/PF-04950615), a Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, in Hypercholesterolemic Japanese Subjects Receiving a Stable Dose of Atorvastatin or Treatment-Naive - Results From a Randomized, Placebo-Controlled, Dose-Ranging Study. Circ J. 2017 Sep 25;81(10):1496-1505. doi: 10.1253/circj.CJ-16-1310. Epub 2017 May 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bococizumab	Monoclonal antibody	50 mg	Subcutaneous
Subject	Bococizumab	Monoclonal antibody	100 mg	Subcutaneous
Subject	Bococizumab	Monoclonal antibody	150 mg	Subcutaneous
Subject	Ezetimibe	Unknown	10 mg	Oral

Indications