Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin

Summary

To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose LDL-cholesterol is \>/=80 mg/dL on background treatment with a statin.

Timeline

Start

2012-07

Primary completion

2013-04

Completion

2013-05

Outcome

Met primary endpoint

registry Placebo: Every 14 Days vs PF-04950615 50 mg: Every 14 Days; p <0.001; Adjusted mean difference -34.28 NCT01592240 ↗

registry Placebo: Every 14 Days vs PF-04950615 150 mg: Every 14 Days; p <0.001; Adjusted mean difference -53.42 (95% CI -64.14 to -42.70) NCT01592240 ↗

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.
• Ballantyne CM, Neutel J, Cropp A, Duggan W, Wang EQ, Plowchalk D, Sweeney K, Kaila N, Vincent J, Bays H. Results of bococizumab, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9, from a randomized, placebo-controlled, dose-ranging study in statin-treated subjects with hypercholesterolemia. Am J Cardiol. 2015 May 1;115(9):1212-21. doi: 10.1016/j.amjcard.2015.02.006. Epub 2015 Feb 12.

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	Bococizumab	Monoclonal antibody	200 mg	Subcutaneous
Subject	Bococizumab	Monoclonal antibody	300 mg	Subcutaneous

Indications