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CompletedNCT01350141Updated Nov 8, 2017Results posted

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

A Phase 2 interventional study of Placebo and PF-04950615 (RN316) in Hypercholesterolemia and Dyslipidemia, sponsored by Pfizer. Completed at 35 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-08.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.

02

Conditions studied

  • Hypercholesterolemia
  • Dyslipidemia

Keywords

  • Hypercholesterolemia
  • dyslipidemia
  • high cholesterol
  • LDL
  • antibody
  • PCSK9
  • PF-04950615
  • RN316
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 46 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Body Mass Index (BMI) of 18.5 to 40 kg/m2
  • On a stable maximum daily dose of a statin, defined as atorvastatin 80 mg or rosuvastatin 40 mg for a minimum of 45 days prior to Day 1.
  • Lipids meet the following criteria twice during screening period:
  • Fasting LDL C = or > 80 mg/dL;
  • Fasting TG \< 400 mg/dL.

Exclusion criteria

Exclusion Criteria:

  • History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past year.
  • Poorly controlled type 1 or type 2 diabetes mellitus.
  • Poorly controlled hypertension.
  • Fasting triglycerides > 400 mg/dL
  • 12 lead ECG demonstrating QTcFF >455 msec at screening.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
46 participants (actual)

Study arms

  • Placebo comparator
    Treatment A

    Other: Placebo

  • Experimental
    Treatment B

    Drug: PF-04950615 (RN316)

  • Experimental
    Treatment C

    Drug: PF-04950615 (RN316)

Interventions

  • OtherPlacebo

    An infusion lasting approximately 60 minutes

  • DrugPF-04950615 (RN316)

    An infusion lasting approximately 60 minutes

  • DrugPF-04950615 (RN316)

    An infusion lasting approximately 60 minutes

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85

    Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.

    Time frame: Baseline, Day 85

Secondary outcomes

  1. Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL)

    Time frame: Day 29, 57, 85

  2. Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)

    Time frame: Day 29, 57, 85

  3. Change From Baseline in Lipid Parameters at Day 29, 57 and 85

    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.

    Time frame: Baseline, Day 29, 57, 85

  4. Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85

    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.

    Time frame: Baseline, Day 29, 57, 85

  5. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    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.

    Time frame: Day 1 up to Day 141

  6. Number of Treatment-Emergent Adverse Events (TEAEs) by Severity

    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.

    Time frame: Day 1 up to Day 141

  7. Number of Participants With Clinically Significant Laboratory Abnormalities

    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.

    Time frame: Screening up to Day 141

  8. Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters

    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.

    Time frame: Screening up to Day 141

  9. Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA)

    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.

    Time frame: Day 1 up to Day 141

07

Results

Posted Nov 8, 2017
Limitations and caveats
Due to an inadvertent omission in the protocol at Day 85, presented limitations in data collection and the assessment of treatment effect on ApoA1 and ApoB for Day 85.

Participant flow

Participant flow — Overall Study
MilestonePlaceboPF-04950615 (RN316) 1 mg/kgPF-04950615 (RN316) 3 mg/kg
Started151516
Treated141516
Completed121515
Not completed301
Withdrew: Lost to follow-up101
Withdrew: Withdrawal by subject100
Withdrew: Randomized but not treated100

Outcome measures

PrimaryPercent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85

Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.

Time frame:
Baseline, Day 85
Reported as:
Mean · percent change
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85
percent changePlaceboPF-04950615 (RN316) 1 mg/kgPF-04950615 (RN316) 3 mg/kg
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 854.05 ± 21.688-14.95 ± 19.016-44.84 ± 27.186
Statistical analysis
  • Placebo vs PF-04950615 (RN316) 1 mg/kg · ANCOVA · p = 0.0137 · Least squares (ls) mean difference: -21.81 · 95% CI -38.85 to -4.77
  • Placebo vs PF-04950615 (RN316) 3 mg/kg · ANCOVA · p = <0.0001 · Ls mean difference: -46.42 · 95% CI -63.62 to -29.22
SecondaryPercentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL)
Time frame:
Day 29, 57, 85
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL)
Percentage of participantsPlaceboPF-04950615 (RN316) 1 mg/kgPF-04950615 (RN316) 3 mg/kg
Day 29 less than 70 mg/dL0.020.080.0
Day 29 less than 100 mg/dL15.486.7100
Day 57 less than 70 mg/dL8.313.362.5
Day 57 less than 100 mg/dL33.373.387.5
Day 85 less than 70 mg/dL0.06.750.0
Day 85 less than 100 mg/dL33.373.392.9
Statistical analysis
  • Placebo vs PF-04950615 (RN316) 1 mg/kg · Regression, Logistic · p = 0.1900 · Odds ratio (or): 7.825 · 95% CI 0.36 to 169.74
  • Placebo vs PF-04950615 (RN316) 3 mg/kg · Regression, Logistic · p = 0.0057 · Odds ratio (or): 72.518 · 95% CI 3.48 to 1512.10
  • Placebo vs PF-04950615 (RN316) 1 mg/kg · Regression, Logistic · p = 0.0013 · Odds ratio (or): 24.750 · 95% CI 3.49 to 175.63
  • Placebo vs PF-04950615 (RN316) 3 mg/kg · Regression, Logistic · p = 0.0006 · Odds ratio (or): 47.326 · 95% CI 5.26 to 426.01
  • Placebo vs PF-04950615 (RN316) 1 mg/kg · Regression, Logistic · p = 0.6611 · Odds ratio (or): 1.635 · 95% CI 0.18 to 14.73
  • Placebo vs PF-04950615 (RN316) 3 mg/kg · Regression, Logistic · p = 0.0104 · Odds ratio (or): 13.486 · 95% CI 1.84 to 98.61
  • Placebo vs PF-04950615 (RN316) 1 mg/kg · Regression, Logistic · p = 0.0282 · Odds ratio (or): 6.430 · 95% CI 1.22 to 33.89
  • Placebo vs PF-04950615 (RN316) 3 mg/kg · Regression, Logistic · p = 0.0042 · Odds ratio (or): 15.257 · 95% CI 2.36 to 98.42
  • Placebo vs PF-04950615 (RN316) 1 mg/kg · Regression, Logistic · p = 0.5164 · Odds ratio (or): 2.967 · 95% CI 0.11 to 79.24
  • Placebo vs PF-04950615 (RN316) 3 mg/kg · Regression, Logistic · p = 0.0445 · Odds ratio (or): 21.360 · 95% CI 1.08 to 422.94
  • Placebo vs PF-04950615 (RN316) 1 mg/kg · Regression, Logistic · p = 0.0223 · Odds ratio (or): 8.157 · 95% CI 1.35 to 49.37
  • Placebo vs PF-04950615 (RN316) 3 mg/kg · Regression, Logistic · p = 0.0070 · Odds ratio (or): 13.587 · 95% CI 2.04 to 90.40
SecondaryPercentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame:
Day 29, 57, 85
Reported as:
Number · percentage of participants
Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)
percentage of participantsPlaceboPF-04950615 (RN316) 1 mg/kgPF-04950615 (RN316) 3 mg/kg
Day 290.013.3100
Day 578.326.775.0
Day 850.020.071.4
Statistical analysis
  • Placebo vs PF-04950615 (RN316) 1 mg/kg · Regression, Logistic · p = 0.2928 · Odds ratio (or): 5.647 · 95% CI 0.22 to 142.04
  • Placebo vs PF-04950615 (RN316) 3 mg/kg · Regression, Logistic · p = 0.0014 · Odds ratio (or): 591.174 · 95% CI 11.68 to 29922.99
  • Placebo vs PF-04950615 (RN316) 1 mg/kg · Regression, Logistic · p = 0.2339 · Odds ratio (or): 3.468 · 95% CI 0.45 to 26.88
  • Placebo vs PF-04950615 (RN316) 3 mg/kg · Regression, Logistic · p = 0.0025 · Odds ratio (or): 23.442 · 95% CI 3.03 to 181.11
  • Placebo vs PF-04950615 (RN316) 1 mg/kg · Regression, Logistic · p = 0.1786 · Odds ratio (or): 8.502 · 95% CI 0.38 to 192.32
  • Placebo vs PF-04950615 (RN316) 3 mg/kg · Regression, Logistic · p = 0.0121 · Odds ratio (or): 51.185 · 95% CI 2.37 to 1107.57
SecondaryChange From Baseline in Lipid Parameters at Day 29, 57 and 85

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.

Time frame:
Baseline, Day 29, 57, 85
Reported as:
Mean · mg/dL
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
mg/dLPlaceboPF-04950615 (RN316) 1 mg/kgPF-04950615 (RN316) 3 mg/kg
Baseline HDL-C50.71 ± 12.27750.63 ± 11.48448.38 ± 12.905
Baseline TC191.14 ± 27.968189.07 ± 26.443195.34 ± 46.904
Baseline non-HDL-C140.43 ± 24.031138.43 ± 29.850146.97 ± 44.046
Baseline TG122.14 ± 56.077156.50 ± 76.013109.91 ± 45.854
Baseline ApoB91.57 ± 21.42599.67 ± 21.784100.88 ± 24.916
Baseline ApoA1140.79 ± 25.057146.73 ± 23.639143.81 ± 31.503
Change at Day 29 HDL-C0.92 ± 10.620-0.43 ± 4.3305.53 ± 5.051
Change at Day 29 TC1.46 ± 20.821-23.00 ± 16.566-64.60 ± 22.634
Change at Day 29 non-HDL-C0.54 ± 17.159-22.57 ± 16.804-71.40 ± 22.392
Change at Day 29 TG-5.38 ± 42.455-23.37 ± 64.145-26.00 ± 39.128
Change at Day 29 ApoB6.77 ± 17.758-8.80 ± 14.561-43.75 ± 12.520
Change at Day 29 ApoA16.15 ± 28.705-2.80 ± 17.3508.58 ± 21.245
Change at Day 57 HDL-C-2.00 ± 7.138-0.23 ± 5.6724.56 ± 8.072
Change at Day 57 TC-12.79 ± 30.000-22.87 ± 33.173-52.66 ± 24.873
Change at Day 57 non-HDL-C-10.79 ± 31.447-22.63 ± 29.960-57.22 ± 29.026
Change at Day 57 TG-5.88 ± 67.487-17.90 ± 44.184-23.97 ± 19.365
Change at Day 57 ApoB7.75 ± 22.483-8.47 ± 19.588-32.20 ± 20.772
Change at Day 57 ApoA10.50 ± 23.240-1.27 ± 15.3691.67 ± 21.043
Change at Day 85 HDL-C-1.42 ± 5.6843.30 ± 6.9591.79 ± 8.398
Change at Day 85 TC3.58 ± 26.618-17.60 ± 28.357-66.07 ± 45.818
Change at Day 85 non-HDL5.00 ± 27.376-20.90 ± 25.716-64.32 ± 50.664
Change at Day 85 TG6.17 ± 48.767-21.10 ± 36.414-12.77 ± 41.558
SecondaryPercent Change From Baseline in Lipid Parameters at Day 29, 57 and 85

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.

Time frame:
Baseline, Day 29, 57, 85
Reported as:
Mean · percent change
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
percent changePlaceboPF-04950615 (RN316) 1 mg/kgPF-04950615 (RN316) 3 mg/kg
Percent change at Day 29 HDL-C0.50 ± 17.279-1.09 ± 7.93511.93 ± 13.039
Percent change at Day 29 TC0.64 ± 10.318-12.63 ± 9.125-35.00 ± 13.281
Percent change at Day 29 non-HDL-C0.74 ± 12.018-17.84 ± 14.222-52.65 ± 17.491
Percent change at Day 29 TG1.54 ± 38.088-11.15 ± 32.714-17.18 ± 23.596
Percent change at Day 29 ApoB11.65 ± 26.113-7.59 ± 13.739-43.43 ± 11.125
Percent change at Day 29 ApoA15.63 ± 23.400-1.45 ± 10.7168.34 ± 16.131
Percent change at Day 57 HDL-C-3.17 ± 14.071-0.80 ± 10.7848.52 ± 15.458
Percent change at Day 57 TC-7.69 ± 17.098-11.42 ± 16.477-26.58 ± 11.010
Percent change at Day 57 non-HDL-C-8.79 ± 23.929-14.74 ± 19.775-37.95 ± 15.373
Percent change at Day 57 TG-3.94 ± 45.205-2.56 ± 33.634-20.56 ± 15.081
Percent change at Day 57 ApoB11.56 ± 25.094-7.03 ± 17.796-30.35 ± 17.065
Percent change at Day 57 ApoA12.41 ± 19.469-0.02 ± 10.5031.72 ± 15.505
Percent change at Day 85 HDL-C-1.75 ± 10.3605.64 ± 12.2213.18 ± 16.233
Percent change at Day 85 TC1.81 ± 13.580-9.36 ± 14.579-32.16 ± 20.664
Percent change at Day 85 non-HDL-C3.28 ± 19.529-14.35 ± 17.206-40.37 ± 27.589
Percent change at Day 85 TG6.17 ± 36.703-8.28 ± 24.530-11.49 ± 32.647
SecondaryNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)

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.

Time frame:
Day 1 up to Day 141
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
ParticipantsPlaceboPF-04950615 (RN316) 1 mg/kgPF-04950615 (RN316) 3 mg/kg
TEAEs (All causalities)9129
TESAEs (All causalities)010
Treatment related TEAEs234
SecondaryNumber of Treatment-Emergent Adverse Events (TEAEs) by Severity

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.

Time frame:
Day 1 up to Day 141
Reported as:
Number · Treatment-emergent AEs
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
Treatment-emergent AEsPlaceboPF-04950615 (RN316) 1 mg/kgPF-04950615 (RN316) 3 mg/kg
Mild123420
Moderate2197
Severe000
SecondaryNumber of Participants With Clinically Significant Laboratory Abnormalities

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.

Time frame:
Screening up to Day 141
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Laboratory Abnormalities
ParticipantsPlaceboPF-04950615 (RN316) 1 mg/kgPF-04950615 (RN316) 3 mg/kg
Number of Participants With Clinically Significant Laboratory Abnormalities121516
SecondaryNumber of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters

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.

Time frame:
Screening up to Day 141
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
ParticipantsPlaceboPF-04950615 (RN316) 1 mg/kgPF-04950615 (RN316) 3 mg/kg
Supine systolic BP: Maximum increase >=30mmHg022
Supine diastolic BP: Maximum increase >=20mmHg203
Supine systolic BP: Maximum decrease >=30mmHg133
Supine diastolic BP: Maximum decrease >=20mmHg241
PR interval: >=25/50% increase000
QRS interval: >=25/50% increase000
QTCF: Maximum increase >30 to <=60 msec311
QTCF: Maximum increase >60 msec000
SecondaryNumber of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA)

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.

Time frame:
Day 1 up to Day 141
Reported as:
Number · participants
Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA)
participantsPF-04950615 (RN316) 1 mg/kgPF-04950615 (RN316) 3 mg/kg
Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA)00

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/14 (0%)9/14 (64.3%)
PF-04950615 (RN316) 1 mg/kg—1/15 (6.7%)12/15 (80%)
PF-04950615 (RN316) 3 mg/kg—0/16 (0%)9/16 (56.3%)
Most frequent serious events
Most frequent serious events
EventPlaceboPF-04950615 (RN316) 1 mg/kgPF-04950615 (RN316) 3 mg/kg
Non-cardiac chest painGeneral disorders0/141/150/16
Most frequent other events
Showing 10 of 67
Most frequent other events
EventPlaceboPF-04950615 (RN316) 1 mg/kgPF-04950615 (RN316) 3 mg/kg
Upper respiratory tract infectionInfections and infestations0/144/151/16
HeadacheNervous system disorders3/143/153/16
NauseaGastrointestinal disorders0/143/150/16
Non-cardiac chest painGeneral disorders0/142/150/16
EpistaxisRespiratory, thoracic and mediastinal disorders0/142/150/16
DiarrhoeaGastrointestinal disorders1/140/152/16
Oedema peripheralGeneral disorders1/140/150/16
NasopharyngitisInfections and infestations1/141/151/16
Oral herpesInfections and infestations1/140/150/16
Blood cortisol decreasedInvestigations1/141/150/16

Baseline characteristics

Safety analysis set included all participants who received at least 1 dose of study medication.

Age, Continuous
Age, Continuous(years)PlaceboPF-04950615 (RN316) 1 mg/kgPF-04950615 (RN316) 3 mg/kgTotal
Mean54.1 ± 10.956.3 ± 10.957.6 ± 9.056 ± 10.1
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboPF-04950615 (RN316) 1 mg/kgPF-04950615 (RN316) 3 mg/kgTotal
Female67922
Male88723
08

Study locations

35 sites
  • Achieve Clinical Research, LLC
    Birmingham, Alabama 35216, United States
  • Advance Outcome Management, Inc.
    Garden Grove, California 92845, United States
  • Collaborative Neuroscience Network, Inc
    Garden Grove, California 92845, United States
  • Collaborative Neuroscience Network, Inc.
    Long Beach, California 90806, United States
  • Elite Clinical Trials, Inc.
    Wildomar, California 92595, United States
  • Innovative Research of West Florida, Inc.
    Clearwater, Florida 33756, United States
  • Avail Clinical Research, LLC
    DeLand, Florida 32720, United States
  • Kendall South Medical Center, Inc.
    Miami, Florida 33185, United States
  • Compass Research, LLC
    Orlando, Florida 32806, United States
  • Atlanta Diabetes Associates
    Atlanta, Georgia 30309, United States
  • Midwest Cardiology Associates
    Overland Park, Kansas 66209, United States
  • Stark Pharmacy
    Overland Park, Kansas 66209, United States
  • Vince and Associates Clinical Research
    Overland Park, Kansas 66212, United States
  • Saint Luke's Hospital
    Kansas City, Missouri 64111, United States
  • Saint Luke's Lipid and Diabetes Research Center
    Kansas City, Missouri 64111, United States
  • Advance Clinical Research
    Saint Louis, Missouri 63128, United States
  • Wake Internal Medicine Consultants, Inc.
    Raleigh, North Carolina 27612, United States
  • Wake Research Associates, LLC
    Raleigh, North Carolina 27612, United States
  • Lynn Health Science Institute
    Oklahoma City, Oklahoma 73112, United States
  • Oklahoma Cardiovascular Research Group
    Oklahoma City, Oklahoma 73120, United States
  • Oklahoma Heart Hospital Physicians
    Oklahoma City, Oklahoma 73120, United States
  • Oklahoma Heart Hospital
    Oklahoma City, Oklahoma 73120, United States
  • Altoona Center for Clinical Research
    Duncansville, Pennsylvania 16635, United States
  • DeGarmo Institute of Medical Research
    Greer, South Carolina 29651, United States
  • Holston Medical Group
    Kingsport, Tennessee 37660, United States
  • Texas Center for Drug Development, Inc
    Houston, Texas 77081, United States
  • Martin Diagnostic Clinic
    Tomball, Texas 77375, United States
  • Aspen Clinical Research, LLC
    Orem, Utah 84058, United States
  • National Clinical Research - Richmond, Inc.
    Richmond, Virginia 23294, United States
  • The Medical Arts Health Research Group
    Kelowna, British Columbia V1Y 3G8, Canada
  • Q & T Research Chicoutimi
    Chicoutimi, Quebec G7H 7Y8, Canada
  • Centre de Recherche Clinique de Laval
    Laval, Quebec H7T 2P5, Canada
  • Diex Research Montreal Inc.
    Montreal, Quebec H4N 3C5, Canada
  • Diex Research Sherbrooke Inc.
    Sherbrooke, Quebec J1H 1Z1, Canada
  • Clinique des Maladies Lipidiques de Quebec Inc.
    Quebec, G1V 4M6, Canada
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References and documents

Publications

  • 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. PubMed 29037448 ↗
  • 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. PubMed 28181260 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01350141
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
May 9, 2011
Start date
Jun 2011
Primary completion
Apr 2012
Completion
Jun 2012
Results posted
Nov 8, 2017
Last update
Nov 8, 2017

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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