Dyslipidemia, Hypercholesterolemia
Conditions
Keywords
Hypercholesterolemia, dyslipidemia, high cholesterol, LDL, antibody, PCSK9, PF-04950615, RN316
Brief summary
PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.
Interventions
OTHERPlacebo
An infusion lasting approximately 60 minutes
An infusion lasting approximately 60 minutes
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 | Baseline, Day 85 | Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 29, 57, 85 | — |
| Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline, Day 29, 57, 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. |
| Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline, Day 29, 57, 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. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 1 up to Day 141 | 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. |
| Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 29, 57, 85 | — |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Screening up to Day 141 | 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 Electrocardiogram (ECG) Parameters | Screening up to Day 141 | 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. |
| Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA) | Day 1 up to Day 141 | 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. |
| Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Day 1 up to Day 141 | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. | 14 |
| PF-04950615 (RN316) 1 mg/kg Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. | 15 |
| PF-04950615 (RN316) 3 mg/kg Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. | 16 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 1 |
| Overall Study | Randomized but not treated | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | PF-04950615 (RN316) 1 mg/kg | PF-04950615 (RN316) 3 mg/kg | Total |
|---|---|---|---|---|
| Age, Continuous | 54.1 years STANDARD_DEVIATION 10.9 | 56.3 years STANDARD_DEVIATION 10.9 | 57.6 years STANDARD_DEVIATION 9 | 56 years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 9 Participants | 22 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 7 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 14 | 12 / 15 | 9 / 16 |
| serious Total, serious adverse events | 0 / 14 | 1 / 15 | 0 / 16 |
Outcome results
Primary
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
Population: Efficacy analysis set included all participants who received at least 1 dose of study medication and completed the Day 85 visit or dropped out prematurely, whichever was earlier. Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 | 4.05 percent change | Standard Deviation 21.688 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 | -14.95 percent change | Standard Deviation 19.016 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 | -44.84 percent change | Standard Deviation 27.186 |
Comparison: Analysis was performed using analysis of covariance (ANCOVA) model with treatment, background statin as independent factors and treatment by background statin interaction, baseline LDL-C as covariate.p-value: 0.013795% CI: [-38.85, -4.77]ANCOVA
Comparison: Analysis was performed using ANCOVA model with treatment, background statin as independent factors and treatment by background statin interaction, baseline LDL-C as covariate.p-value: <0.000195% CI: [-63.62, -29.22]ANCOVA
Secondary
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
Population: Efficacy analysis set. 'Number of participants analyzed' = participants who were evaluable for this measure at given time points for each arm. Results for change at Day 85 for ApoB and ApoA1 were not reported as data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85 TC | 3.58 mg/dL | Standard Deviation 26.618 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 TG | -5.88 mg/dL | Standard Deviation 67.487 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 non-HDL-C | 0.54 mg/dL | Standard Deviation 17.159 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline TG | 122.14 mg/dL | Standard Deviation 56.077 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 non-HDL-C | -10.79 mg/dL | Standard Deviation 31.447 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 TG | -5.38 mg/dL | Standard Deviation 42.455 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85 TG | 6.17 mg/dL | Standard Deviation 48.767 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 TC | -12.79 mg/dL | Standard Deviation 30 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 ApoB | 6.77 mg/dL | Standard Deviation 17.758 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85 HDL-C | -1.42 mg/dL | Standard Deviation 5.684 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 HDL-C | -2.00 mg/dL | Standard Deviation 7.138 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 ApoA1 | 6.15 mg/dL | Standard Deviation 28.705 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline ApoB | 91.57 mg/dL | Standard Deviation 21.425 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85 non-HDL | 5.00 mg/dL | Standard Deviation 27.376 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 ApoA1 | 0.50 mg/dL | Standard Deviation 23.24 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline ApoA1 | 140.79 mg/dL | Standard Deviation 25.057 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline non-HDL-C | 140.43 mg/dL | Standard Deviation 24.031 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline HDL-C | 50.71 mg/dL | Standard Deviation 12.277 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 HDL-C | 0.92 mg/dL | Standard Deviation 10.62 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline TC | 191.14 mg/dL | Standard Deviation 27.968 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 ApoB | 7.75 mg/dL | Standard Deviation 22.483 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 TC | 1.46 mg/dL | Standard Deviation 20.821 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 ApoB | -8.47 mg/dL | Standard Deviation 19.588 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline HDL-C | 50.63 mg/dL | Standard Deviation 11.484 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline TC | 189.07 mg/dL | Standard Deviation 26.443 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline non-HDL-C | 138.43 mg/dL | Standard Deviation 29.85 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline TG | 156.50 mg/dL | Standard Deviation 76.013 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline ApoB | 99.67 mg/dL | Standard Deviation 21.784 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline ApoA1 | 146.73 mg/dL | Standard Deviation 23.639 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 HDL-C | -0.43 mg/dL | Standard Deviation 4.33 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 TC | -23.00 mg/dL | Standard Deviation 16.566 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 non-HDL-C | -22.57 mg/dL | Standard Deviation 16.804 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 TG | -23.37 mg/dL | Standard Deviation 64.145 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 ApoB | -8.80 mg/dL | Standard Deviation 14.561 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 ApoA1 | -2.80 mg/dL | Standard Deviation 17.35 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 HDL-C | -0.23 mg/dL | Standard Deviation 5.672 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 TC | -22.87 mg/dL | Standard Deviation 33.173 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 non-HDL-C | -22.63 mg/dL | Standard Deviation 29.96 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 TG | -17.90 mg/dL | Standard Deviation 44.184 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 ApoA1 | -1.27 mg/dL | Standard Deviation 15.369 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85 HDL-C | 3.30 mg/dL | Standard Deviation 6.959 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85 TC | -17.60 mg/dL | Standard Deviation 28.357 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85 non-HDL | -20.90 mg/dL | Standard Deviation 25.716 |
| PF-04950615 (RN316) 1 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85 TG | -21.10 mg/dL | Standard Deviation 36.414 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 non-HDL-C | -57.22 mg/dL | Standard Deviation 29.026 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 TC | -64.60 mg/dL | Standard Deviation 22.634 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline TC | 195.34 mg/dL | Standard Deviation 46.904 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 TG | -23.97 mg/dL | Standard Deviation 19.365 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 HDL-C | 5.53 mg/dL | Standard Deviation 5.051 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline ApoA1 | 143.81 mg/dL | Standard Deviation 31.503 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 ApoB | -32.20 mg/dL | Standard Deviation 20.772 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline ApoB | 100.88 mg/dL | Standard Deviation 24.916 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85 TG | -12.77 mg/dL | Standard Deviation 41.558 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 ApoA1 | 1.67 mg/dL | Standard Deviation 21.043 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline TG | 109.91 mg/dL | Standard Deviation 45.854 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85 non-HDL | -64.32 mg/dL | Standard Deviation 50.664 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85 HDL-C | 1.79 mg/dL | Standard Deviation 8.398 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 ApoA1 | 8.58 mg/dL | Standard Deviation 21.245 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 ApoB | -43.75 mg/dL | Standard Deviation 12.52 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline non-HDL-C | 146.97 mg/dL | Standard Deviation 44.046 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 HDL-C | 4.56 mg/dL | Standard Deviation 8.072 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 TG | -26.00 mg/dL | Standard Deviation 39.128 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline HDL-C | 48.38 mg/dL | Standard Deviation 12.905 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57 TC | -52.66 mg/dL | Standard Deviation 24.873 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29 non-HDL-C | -71.40 mg/dL | Standard Deviation 22.392 |
| PF-04950615 (RN316) 3 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85 TC | -66.07 mg/dL | Standard Deviation 45.818 |
Secondary
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
Population: Analysis set included all participants who received at least 1 dose of PF-04950615 (RN316).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA) | 0 participants |
| PF-04950615 (RN316) 1 mg/kg | Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA) | 0 participants |
Secondary
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
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine systolic BP: Maximum increase >=30mmHg | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine diastolic BP: Maximum increase >=20mmHg | 2 Participants |
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine systolic BP: Maximum decrease >=30mmHg | 1 Participants |
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine diastolic BP: Maximum decrease >=20mmHg | 2 Participants |
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | PR interval: >=25/50% increase | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QRS interval: >=25/50% increase | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QTCF: Maximum increase >30 to <=60 msec | 3 Participants |
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QTCF: Maximum increase >60 msec | 0 Participants |
| PF-04950615 (RN316) 1 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine systolic BP: Maximum decrease >=30mmHg | 3 Participants |
| PF-04950615 (RN316) 1 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QTCF: Maximum increase >30 to <=60 msec | 1 Participants |
| PF-04950615 (RN316) 1 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine diastolic BP: Maximum decrease >=20mmHg | 4 Participants |
| PF-04950615 (RN316) 1 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | PR interval: >=25/50% increase | 0 Participants |
| PF-04950615 (RN316) 1 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QRS interval: >=25/50% increase | 0 Participants |
| PF-04950615 (RN316) 1 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine systolic BP: Maximum increase >=30mmHg | 2 Participants |
| PF-04950615 (RN316) 1 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine diastolic BP: Maximum increase >=20mmHg | 0 Participants |
| PF-04950615 (RN316) 1 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QTCF: Maximum increase >60 msec | 0 Participants |
| PF-04950615 (RN316) 3 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine systolic BP: Maximum decrease >=30mmHg | 3 Participants |
| PF-04950615 (RN316) 3 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine diastolic BP: Maximum increase >=20mmHg | 3 Participants |
| PF-04950615 (RN316) 3 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine systolic BP: Maximum increase >=30mmHg | 2 Participants |
| PF-04950615 (RN316) 3 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine diastolic BP: Maximum decrease >=20mmHg | 1 Participants |
| PF-04950615 (RN316) 3 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QTCF: Maximum increase >30 to <=60 msec | 1 Participants |
| PF-04950615 (RN316) 3 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QRS interval: >=25/50% increase | 0 Participants |
| PF-04950615 (RN316) 3 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | PR interval: >=25/50% increase | 0 Participants |
| PF-04950615 (RN316) 3 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QTCF: Maximum increase >60 msec | 0 Participants |
Secondary
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
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | 12 Participants |
| PF-04950615 (RN316) 1 mg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities | 15 Participants |
| PF-04950615 (RN316) 3 mg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities | 16 Participants |
Secondary
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
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TESAEs (All causalities) | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs (All causalities) | 9 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment related TEAEs | 2 Participants |
| PF-04950615 (RN316) 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TESAEs (All causalities) | 1 Participants |
| PF-04950615 (RN316) 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs (All causalities) | 12 Participants |
| PF-04950615 (RN316) 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment related TEAEs | 3 Participants |
| PF-04950615 (RN316) 3 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs (All causalities) | 9 Participants |
| PF-04950615 (RN316) 3 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment related TEAEs | 4 Participants |
| PF-04950615 (RN316) 3 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TESAEs (All causalities) | 0 Participants |
Secondary
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
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Moderate | 2 Treatment-emergent AEs |
| Placebo | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Mild | 12 Treatment-emergent AEs |
| Placebo | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Severe | 0 Treatment-emergent AEs |
| PF-04950615 (RN316) 1 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Moderate | 19 Treatment-emergent AEs |
| PF-04950615 (RN316) 1 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Mild | 34 Treatment-emergent AEs |
| PF-04950615 (RN316) 1 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Severe | 0 Treatment-emergent AEs |
| PF-04950615 (RN316) 3 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Mild | 20 Treatment-emergent AEs |
| PF-04950615 (RN316) 3 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Severe | 0 Treatment-emergent AEs |
| PF-04950615 (RN316) 3 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Moderate | 7 Treatment-emergent AEs |
Secondary
Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: Day 29, 57, 85
Population: Efficacy analysis set. Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and Number of Participants Analyzed signifies those participants who were evaluable for this measure at given time points, for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 85 | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 57 | 8.3 percentage of participants |
| Placebo | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 29 | 0.0 percentage of participants |
| PF-04950615 (RN316) 1 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 85 | 20.0 percentage of participants |
| PF-04950615 (RN316) 1 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 29 | 13.3 percentage of participants |
| PF-04950615 (RN316) 1 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 57 | 26.7 percentage of participants |
| PF-04950615 (RN316) 3 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 85 | 71.4 percentage of participants |
| PF-04950615 (RN316) 3 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 29 | 100 percentage of participants |
| PF-04950615 (RN316) 3 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 57 | 75.0 percentage of participants |
Comparison: Day 29: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.292895% CI: [0.22, 142.04]Regression, Logistic
Comparison: Day 29: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.001495% CI: [11.68, 29922.99]Regression, Logistic
Comparison: Day 57: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.233995% CI: [0.45, 26.88]Regression, Logistic
Comparison: Day 57: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.002595% CI: [3.03, 181.11]Regression, Logistic
Comparison: Day 85: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.178695% CI: [0.38, 192.32]Regression, Logistic
Comparison: Day 85: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.012195% CI: [2.37, 1107.57]Regression, Logistic
Secondary
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
Population: Efficacy analysis set. Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and Number of participants analyzed signifies those participants who were evaluable for this measure at given time points, for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 29 less than 70 mg/dL | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 29 less than 100 mg/dL | 15.4 Percentage of participants |
| Placebo | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 57 less than 70 mg/dL | 8.3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 57 less than 100 mg/dL | 33.3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 85 less than 70 mg/dL | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 85 less than 100 mg/dL | 33.3 Percentage of participants |
| PF-04950615 (RN316) 1 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 85 less than 100 mg/dL | 73.3 Percentage of participants |
| PF-04950615 (RN316) 1 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 29 less than 70 mg/dL | 20.0 Percentage of participants |
| PF-04950615 (RN316) 1 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 57 less than 100 mg/dL | 73.3 Percentage of participants |
| PF-04950615 (RN316) 1 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 85 less than 70 mg/dL | 6.7 Percentage of participants |
| PF-04950615 (RN316) 1 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 29 less than 100 mg/dL | 86.7 Percentage of participants |
| PF-04950615 (RN316) 1 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 57 less than 70 mg/dL | 13.3 Percentage of participants |
| PF-04950615 (RN316) 3 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 29 less than 100 mg/dL | 100 Percentage of participants |
| PF-04950615 (RN316) 3 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 57 less than 70 mg/dL | 62.5 Percentage of participants |
| PF-04950615 (RN316) 3 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 85 less than 100 mg/dL | 92.9 Percentage of participants |
| PF-04950615 (RN316) 3 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 57 less than 100 mg/dL | 87.5 Percentage of participants |
| PF-04950615 (RN316) 3 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 29 less than 70 mg/dL | 80.0 Percentage of participants |
| PF-04950615 (RN316) 3 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 85 less than 70 mg/dL | 50.0 Percentage of participants |
Comparison: Day 29 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.1995% CI: [0.36, 169.74]Regression, Logistic
Comparison: Day 29 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.005795% CI: [3.48, 1512.1]Regression, Logistic
Comparison: Day 29 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.001395% CI: [3.49, 175.63]Regression, Logistic
Comparison: Day 29 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.000695% CI: [5.26, 426.01]Regression, Logistic
Comparison: Day 57 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.661195% CI: [0.18, 14.73]Regression, Logistic
Comparison: Day 57 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.010495% CI: [1.84, 98.61]Regression, Logistic
Comparison: Day 57 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.028295% CI: [1.22, 33.89]Regression, Logistic
Comparison: Day 57 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.004295% CI: [2.36, 98.42]Regression, Logistic
Comparison: Day 85 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.516495% CI: [0.11, 79.24]Regression, Logistic
Comparison: Day 85 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.044595% CI: [1.08, 422.94]Regression, Logistic
Comparison: Day 85 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.022395% CI: [1.35, 49.37]Regression, Logistic
Comparison: Day 85 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.p-value: 0.00795% CI: [2.04, 90.4]Regression, Logistic
Secondary
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
Population: Efficacy analysis set. Number of participants analyzed = participants who were evaluable for this measure at given time points for each arm. Results for percent change at Day 85 for ApoB and ApoA1 were not reported as data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 ApoB | 11.65 percent change | Standard Deviation 26.113 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 TC | 0.64 percent change | Standard Deviation 10.318 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 non-HDL-C | 0.74 percent change | Standard Deviation 12.018 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 TG | 1.54 percent change | Standard Deviation 38.088 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 HDL-C | 0.50 percent change | Standard Deviation 17.279 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 ApoA1 | 5.63 percent change | Standard Deviation 23.4 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 HDL-C | -3.17 percent change | Standard Deviation 14.071 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 TC | -7.69 percent change | Standard Deviation 17.098 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 non-HDL-C | -8.79 percent change | Standard Deviation 23.929 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 TG | -3.94 percent change | Standard Deviation 45.205 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 ApoB | 11.56 percent change | Standard Deviation 25.094 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 ApoA1 | 2.41 percent change | Standard Deviation 19.469 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85 HDL-C | -1.75 percent change | Standard Deviation 10.36 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85 TC | 1.81 percent change | Standard Deviation 13.58 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85 non-HDL-C | 3.28 percent change | Standard Deviation 19.529 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85 TG | 6.17 percent change | Standard Deviation 36.703 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 ApoA1 | -1.45 percent change | Standard Deviation 10.716 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 HDL-C | -0.80 percent change | Standard Deviation 10.784 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 TC | -11.42 percent change | Standard Deviation 16.477 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85 TC | -9.36 percent change | Standard Deviation 14.579 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 non-HDL-C | -14.74 percent change | Standard Deviation 19.775 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 TG | -2.56 percent change | Standard Deviation 33.634 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85 TG | -8.28 percent change | Standard Deviation 24.53 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 ApoB | -7.03 percent change | Standard Deviation 17.796 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 HDL-C | -1.09 percent change | Standard Deviation 7.935 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85 non-HDL-C | -14.35 percent change | Standard Deviation 17.206 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 TC | -12.63 percent change | Standard Deviation 9.125 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 ApoA1 | -0.02 percent change | Standard Deviation 10.503 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 non-HDL-C | -17.84 percent change | Standard Deviation 14.222 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 TG | -11.15 percent change | Standard Deviation 32.714 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 ApoB | -7.59 percent change | Standard Deviation 13.739 |
| PF-04950615 (RN316) 1 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85 HDL-C | 5.64 percent change | Standard Deviation 12.221 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 ApoB | -30.35 percent change | Standard Deviation 17.065 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 ApoA1 | 8.34 percent change | Standard Deviation 16.131 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85 HDL-C | 3.18 percent change | Standard Deviation 16.233 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 non-HDL-C | -52.65 percent change | Standard Deviation 17.491 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 HDL-C | 8.52 percent change | Standard Deviation 15.458 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85 TG | -11.49 percent change | Standard Deviation 32.647 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 HDL-C | 11.93 percent change | Standard Deviation 13.039 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 TC | -26.58 percent change | Standard Deviation 11.01 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 ApoA1 | 1.72 percent change | Standard Deviation 15.505 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 ApoB | -43.43 percent change | Standard Deviation 11.125 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 non-HDL-C | -37.95 percent change | Standard Deviation 15.373 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85 TC | -32.16 percent change | Standard Deviation 20.664 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 TC | -35.00 percent change | Standard Deviation 13.281 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57 TG | -20.56 percent change | Standard Deviation 15.081 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29 TG | -17.18 percent change | Standard Deviation 23.596 |
| PF-04950615 (RN316) 3 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85 non-HDL-C | -40.37 percent change | Standard Deviation 27.589 |