A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins

Summary

This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.

Timeline

Start

2011-07

Primary completion

2012-02

Completion

2012-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs PF-04950615 3.0 mg/kg; p = 0.0001; LS Mean Difference -37.72 (95% CI -56.47 to -18.97); ANCOVA NCT01342211 ↗

registry analysis (superiority or other test); Placebo vs PF-04950615 6.0 mg/kg; p <0.0001; LS Mean Difference -49.11 (95% CI -68.08 to -30.14); ANCOVA NCT01342211 ↗

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.
• Wan H, Gumbiner B, Joh T, Riel T, Udata C, Forgues P, Garzone PD. Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition with Bococizumab on Lipoprotein Particles in Hypercholesterolemic Subjects. Clin Ther. 2017 Nov;39(11):2243-2259.e5. doi: 10.1016/j.clinthera.2017.09.009. Epub 2017 Oct 14.
• Udata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development. J Clin Pharmacol. 2017 Jul;57(7):855-864. doi: 10.1002/jcph.867. Epub 2017 Feb 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bococizumab	Monoclonal antibody	10 mg/ml	Intravenous
Background	Atorvastatin	Small molecule	40 mg	—
Background	Atorvastatin	Small molecule	80 mg	—
Background	Rosuvastatin	Small molecule	20 mg	—
Background	Rosuvastatin	Small molecule	40 mg	—
Background	Simvastatin	Small molecule	40 mg	—
Background	Simvastatin	Small molecule	80 mg	—

Indications