Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins

Summary

This study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are statin intolerant.

Timeline

Start

2014-06

Primary completion

2015-11

Completion

2015-11

Outcome

Met primary endpoint

registry Placebo vs PF-04950615 150 Milligram (mg) + Placebo; p <0.001; Least Square (LS) Mean Difference -54.5 (95% CI -60.1 to -49.0); MMRM NCT02135029 ↗

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.
• Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.

Drugs

Indications