A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins

Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.

Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, TESAEs and treatment-related TEAEs were reported.

An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Investigator assessed adverse events as mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) or severe (interferes significantly with participant's usual function). All causality TEAEs were assessed for severity. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state.

Criteria for clinically significant laboratory abnormalities were based on investigator's discretion. Total number of participants who met the criteria for any laboratory abnormal findings were reported. Laboratory parameters included: hematology, coagulation, liver function, renal function, electrolytes, hormones, chemistry and urinalysis. Screening was 21 days prior to start of study treatment.

Number of participants with clinically significant changes in vital signs and ECG findings were reported. Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of >=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of >=25 percent (%) for baseline value of greater than 200 millisecond (msec) or maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for PR and QRS interval, maximum increase from baseline of greater than (>) 30 to <=60 msec and maximum increase from baseline of >60 msec for QT interval corrected using the Fridericia's formula (QTCF). Screening was 21 days prior to start of study treatment.

Human serum samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value >=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.