Phase 2 Completed N=218 Randomized Triple-blind Treatment

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

Hypercholesterolemia

Source: ClinicalTrials.gov NCT02055976 ↗

Enrolled (actual)

218

Serious AEs

1.4%

Results posted

Feb 2019

Primary outcomePrimary: Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 — -55.65; -68.25; -74.00; -5.91 percent change — p=<0.001

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85	-55.65; -68.25; -74.00; -5.91; -18.56; -47.25	<0.001 sig
PRIMARY Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 113	-54.41; -64.46; -69.98; -12.10; -20.55; -44.94	<0.001 sig
SECONDARY Low Density Lipoprotein-Cholesterol (LDL-C)	135.36; 123.85; 129.19; 135.90; 135.36; 164.22	—
SECONDARY Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 and Day 113	-76.40; -85.85; -95.11; -9.52; -24.73; -77.58	<0.001 sig
SECONDARY Total Cholesterol (TC)	214.16; 210.29; 211.71; 222.44; 222.84; 245.94	—
SECONDARY Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113	-78.64; -90.71; -101.43; -13.56; -24.02; -80.50	<0.001 sig
SECONDARY Percent Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113	-36.26; -42.64; -48.22; -5.47; -10.85; -32.56	<0.001 sig
SECONDARY Apolipoprotein B (ApoB)	92.76; 92.54; 90.40; 95.65; 96.70; 106.54	—
SECONDARY Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113	-41.44; -53.33; -56.43; -2.19; -9.93; -37.86	<0.001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113	-44.30; -57.02; -62.31; -1.77; -9.97; -35.16	<0.001 sig
SECONDARY Apolipoprotein A-I (ApoA-I)	137.02; 142.60; 140.31; 145.65; 145.34; 138.90	—
SECONDARY Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113	1.02; 5.56; 3.63; -9.65; -1.11; -6.02	<0.001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113	0.87; 4.20; 3.26; -6.44; -0.34; -3.82	<0.001 sig
SECONDARY Apolipoprotein A-II (ApoA-II)	30.700; 30.223; 30.471; 31.515; 32.189; 29.940	—
SECONDARY Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113	-0.216; 0.073; -0.450; -0.938; 0.907; -0.904	0.127
SECONDARY Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113	-0.85; 0.17; -1.34; -2.93; 3.13; -2.87	0.155
SECONDARY Lipoprotein (a) (Lp[a])	18.452; 20.998; 18.840; 19.265; 19.468; 14.080	—
SECONDARY Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113	-7.492; -10.119; -10.239; -2.746; -1.859; -5.272	<0.001 sig
SECONDARY Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113	-47.11; -58.53; -46.51; -19.37; -15.22; -37.85	0.004 sig
SECONDARY High Density Lipoprotein- Cholesterol (HDL-C)	54.58; 54.75; 57.00; 58.54; 56.98; 57.22	—
SECONDARY Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113	3.66; 4.79; 2.63; -4.58; 2.80; -2.18	<0.001 sig
SECONDARY Percent Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113	7.26; 9.46; 5.86; -7.31; 5.42; -3.10	<0.001 sig
SECONDARY Very Low Density Lipoprotein-Cholesterol (VLDL-C)	19.92; 23.79; 20.92; 21.42; 22.48; 17.44	—
SECONDARY Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113	-5.68; -6.17; -6.57; 1.15; -2.70; -0.76	<0.001 sig
SECONDARY Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113	-23.42; -22.99; -28.96; 7.08; -6.48; -7.61	<0.001 sig
SECONDARY Triglyceride (TG)	121.04; 158.21; 127.65; 140.23; 152.59; 122.40	—
SECONDARY Change From Baseline in Triglyceride (TG) at Day 85 and Day 113	-28.68; -27.96; -29.52; 2.58; -10.14; -3.76	<0.001 sig
SECONDARY Percent Change From Baseline in Triglyceride (TG) at Day 85 and Day 113	-21.00; -16.85; -23.38; 3.74; -5.20; 2.62	<0.001 sig
SECONDARY Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)	159.58; 155.54; 154.71; 163.90; 165.86; 188.72	—
SECONDARY Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113	-82.30; -95.50; -104.07; -8.98; -26.82; -78.32	<0.001 sig
SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113	-50.98; -60.62; -67.69; -4.77; -16.20; -41.11	<0.001 sig
SECONDARY Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio	4.0118; 4.0154; 3.8500; 3.9629; 4.0223; 4.5408	—
SECONDARY Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113	-1.6394; -1.9433; -1.9835; 0.0879; -0.6236; -1.4204	<0.001 sig
SECONDARY Percent Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113	-39.99; -47.06; -50.43; 2.19; -14.65; -29.51	<0.001 sig
SECONDARY Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio	0.6846; 0.6606; 0.6567; 0.6687; 0.6775; 0.7890	—
SECONDARY Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113	-0.3078; -0.3910; -0.4211; 0.0337; -0.0643; -0.2626	<0.001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113	-44.37; -58.47; -63.09; 5.51; -9.13; -32.09	<0.001 sig
SECONDARY Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 10, 25, 40, 70 and 100 Milligram Per Deciliter	0.0; 4.2; 0.0; 0.0; 0.0; 0.0	—
SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)	17; 16; 13; 13; 5; 16	—
SECONDARY Number of Participants With Anti-Drug Antibody (ADA) Response	14; 6; 14; 13; 16; 11	—
SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615	32.98; 52.33; 77.11; 32.97; 51.49; 82.05	—
SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-04950615	94.83; 176.9; 469.5; 111.7; 237.4; 248.4	—
SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615	87.86; 140.3; 434.2; 96.32; 220.9; 486.7	—
SECONDARY Maximum Observed Plasma Concentration (Cmax) of PF-04950615	3.173; 5.074; 7.382; 2.994; 4.744; 7.726	—
SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) of PF-04950615	2.176; 4.041; 12.95; 2.858; 6.571; 13.47	—
SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615	4.01; 4.97; 5.94; 5.94; 5.45; 6.94	—
SECONDARY Terminal Elimination Half-Life (t1/2) of PF-04950615	7.716; 9.471; 10.56; 9.404; 9.570; 9.333	—
SECONDARY Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)	266.64; 261.23; 285.96; 269.19; 228.80; 215.50	—

Eligibility Criteria

Inclusion Criteria

Subjects whose LDL-C is not controlled by a stable dose of atorvastatin (Population A).
Subjects who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled (Population B).

Exclusion Criteria

Severe acute or chronic medical or psychiatric condition or laboratory abnormality.
Pregnant females; breastfeeding females; males and females of childbearing potential; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
Subjects who were administered or prior exposed to PF-04950615 and/or anti-body targeting PCSK9.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02055976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.