Dyslipidemia, Hypercholesterolemia
Conditions
Keywords
Hypercholesterolemia, Dyslipidemia, LDL, High Cholesterol, Japanese Volunteers, PF-04950615, RN316
Brief summary
The primary objective of this study is to evaluate the safety and tolerability of repeated doses of PF-04950615 (RN316) in study volunteers with hypercholesterolemia. PF-04950615 is an investigational drug that is currently being studied as a lipid lowering agent.
Interventions
BIOLOGICALPF-04950615 (RN316)
Infusion every week
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* LDL-C must be greater or equal to 130 mg/dl * BMI must be between 18.5 and 40 kg/m2 * Japanese volunteers must have 4 Japanese grand parents born in Japan
Exclusion criteria
* History of cardiovascular or cerebrovascular event during the past year. * Poorly controlled type 1 or type 2 diabetes mellitus * Subjects who have taken lipid lowering therapies within the last 3 months of screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs) | Baseline up to Follow-up period (Day 78) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Dose limiting and intolerable treatment-related AEs were the AEs resulting from drug overdose, drug withdrawal, drug abuse, drug misuse, drug interactions, drug dependency, extravasation, exposure in utero, exposure during breast feeding. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs) | Baseline up to Follow-up period (Day 78) | An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 78 that were absent before treatment or that worsened relative to pretreatment state. |
| Number of Participants With Adverse Events (AEs) by Severity | Baseline up to Follow-up period (Day 78) | An AE was any untoward medical occurrence in a participant who received study drug. AE was assessed according to common terminology criteria for adverse events (CTCAE) version 4.0 severity grades- Grade 1: mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2: moderate (minimal, local or non invasive intervention indicated); Grade 3: severe (medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling); Grade 4: Life-threatening consequences; urgent intervention indicated and Grade 5: Death related to AE. |
| Number of Participants With Laboratory Test Abnormalities | Baseline up to Follow-up period (Day 78) | Criteria: Haemoglobin(Hgb), hematocrit, RBC: \<0.8\*lower limit of normal(LLN),mean corpuscular volume, mean corpuscular Hgb concentration \<0.9\*LLN or\>1.1\*upper limit of normal(ULN), platelet\<0.5\*LLN or\>1.75\*ULN, WBC\<0.6\*LLN or\>1.5\*ULN, lymphocyte, neutrophil\<0.8\*LLN or\>1.2\*ULN, basophil, eosinophil, monocyte\>1.2\*ULN; bilirubin\>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, lactate dehydrogenase\>3.0\*ULN,total protein,albumin\<0.8\*LLN or\>1.2\*ULN; blood urea nitrogen, creatinine\>1.3\*ULN,uric acid\>1.2\*ULN;sodium\<0.95\*LLNor\>1.05\*ULN,potassium,chloride,calcium,bicarbonate\<0.9\*LLN or\>1.1\*ULN; glucose\<0.6\*LLN or \>1.5\*ULN, urine specific gravity\<1.003 or\>1.030,urine pH\<4.5or\>8,urine glucose, ketones, urine protein,urine blood/Hgb,urobilinogen,bilirubin,nitrite, leukocyte esterase\>=1; urine RBC,WBC\>=20,urine epithelial cells\>=6,urine granular casts,hyaline casts\>1,urine bacteria\>20,partial thromboplastin time,prothrombin:\>1.1\*ULN. |
| Number of Participants With Clinically Relevant Changes in Vital Signs | Baseline up to Follow-up period (Day 78) | Criteria for clinically relevant vital signs: supine and standing systolic blood pressure (SBP): less than (\<) 90 millimeter of mercury (mmHg); supine and standing diastolic blood pressure (DBP): \<50 mmHg. Maximum increase from baseline (IFB) or decrease from baseline (DFB) in supine and standing SBP: greater than or equal to (\>=) 30 mmHg and maximum IFB or DFB in supine and standing DBP: \>=20 mmHg. Supine pulse rate: \<40 and greater than (\>) 120 beats per minute (bpm); standing pulse rate: \<40 and \>140 bpm. |
| Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | Baseline up to Follow-up period (Day 78) | Criteria for clinically relevant ECG parameters: PR interval: maximum IFB of \>=25 percent or 50 percent; QRS complex: maximum IFB of \>=25 or 50 percent; QTcF interval (Fridericia's Correction): maximum IFB of \>=30 millisecond (msec) to \<60 msec and maximum IFB of \>=60 msec. |
| Number of Participants With Anti-drug Antibodies (ADA) | Baseline up to Follow-up period (Day 78) | The number of participants with at least one positive ADA were summarized for each treatment arm. Participants with positive antibody titer of \>4.32 milligram/milliliter (mg/mL) were considered as ADA positive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Baseline, Day 8, 15, 22, 29 and 78 | — |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Day 8, 15, 22, 29 and 78 | — |
| Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 15, 22, 29 and 36 | — |
| Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 15, 22, 29 and 36 | — |
| Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in LDL-C From Baseline | Baseline, Day 15, 22, 29 and 36 | — |
| Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Baseline, Day 8, 15, 22, 29 and 78 | — |
| Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Baseline, Day 8, 15, 22, 29 and 78 | — |
| Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Baseline, Day 8, 15, 22, 29 and 78 | — |
| Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Baseline, Day 8, 15, 22, 29 and 78 | — |
| Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Baseline, Day 8, 15, 22, 29 and 78 | — |
| Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Baseline, Day 8, 15, 22, 29 and 78 | — |
| Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Day 8, 15, 22, 29 and 78 | — |
| Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Day 8, 15, 22, 29 and 78 | — |
| Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Day 8, 15, 22, 29 and 78 | — |
| Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Day 8, 15, 22, 29 and 78 | — |
| Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Day 8, 15, 22, 29 and 78 | — |
| Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Day 8, 15, 22, 29 and 78 | — |
| Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | — |
| Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | — |
| Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | — |
| Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | — |
| Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | — |
| Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | — |
| Plasma Decay Half-Life (t1/2) of PF-04950615 | Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose | t1/2 was the time measured for the plasma concentration of PF-04950615 to decrease by one half. t1/2 was calculated as Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
| Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8, 15, 22, 36, 50, 64 and 78 | — |
| Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8, 15, 22, 36, 50, 64 and 78 | — |
| Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8, 15, 22, 36, 50, 64 and 78 | — |
| Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8, 15, 22, 36, 50, 64 and 78 | — |
| Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8, 15, 22, 36, 50, 64 and 78 | — |
| Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8, 15, 22, 36, 50, 64 and 78 | — |
| Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8, 15, 22, 36, 50, 64 and 78 | — |
| Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8, 15, 22, 36, 50, 64 and 78 | — |
| High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8, 15, 22, 36, 50, 64 and 78 | — |
| Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8, 15, 22, 36, 50, 64 and 78 | — |
| C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 8, 15, 21, 36, 57 and 78 | — |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615 | Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose | AUCtau is area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau =168 hours. |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose | Tmax is the time at which maximum plasma concentration (Cmax) occurred. |
| Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose | — |
| Apparent Clearance (CL) of PF-04950615 | Day 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose | CL was calculated as Dose/AUCtau. AUCtau is area under the concentration-time profile from time zero to time tau, the dosing interval, where tau=168 hours. |
| Volume of Distribution at Steady State (Vss) of PF-04950615 | Day 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose | Vss was calculated as CL\*MRT. CL was calculated as Dose/AUCtau, where AUCtau was area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau=168 hours. MRT was mean residence time (predicted) extrapolated to infinity. |
| Accumulation Ratio (Rac) of PF-04950615 | Day 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose | Rac was calculated as Day 22 AUCtau divided by Day 1 AUCtau, where AUCtau is area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau =168 hours. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | 12 |
| PF-04950615 0.25 mg/kg Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | 14 |
| PF-04950615 0.50 mg/kg Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | 14 |
| PF-04950615 1.0 mg/kg Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | 13 |
| PF-04950615 1.50 mg/kg Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22. | 14 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Randomized but not treated | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | PF-04950615 0.25 mg/kg | PF-04950615 0.50 mg/kg | PF-04950615 1.0 mg/kg | PF-04950615 1.50 mg/kg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 55.3 years STANDARD_DEVIATION 13.7 | 52.0 years STANDARD_DEVIATION 7.8 | 51.5 years STANDARD_DEVIATION 13 | 52.5 years STANDARD_DEVIATION 14.3 | 55.1 years STANDARD_DEVIATION 8.8 | 53.2 years STANDARD_DEVIATION 11.5 |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 4 Participants | 5 Participants | 6 Participants | 27 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 10 Participants | 8 Participants | 8 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 12 | 8 / 14 | 5 / 14 | 7 / 13 | 9 / 14 |
| serious Total, serious adverse events | 0 / 12 | 1 / 14 | 0 / 14 | 0 / 13 | 0 / 14 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) by Severity
An AE was any untoward medical occurrence in a participant who received study drug. AE was assessed according to common terminology criteria for adverse events (CTCAE) version 4.0 severity grades- Grade 1: mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2: moderate (minimal, local or non invasive intervention indicated); Grade 3: severe (medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling); Grade 4: Life-threatening consequences; urgent intervention indicated and Grade 5: Death related to AE.
Time frame: Baseline up to Follow-up period (Day 78)
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events (AEs) by Severity | Grade 4 | 0 participants |
| Placebo | Number of Participants With Adverse Events (AEs) by Severity | Grade 1 | 8 participants |
| Placebo | Number of Participants With Adverse Events (AEs) by Severity | Grade 5 | 0 participants |
| Placebo | Number of Participants With Adverse Events (AEs) by Severity | Grade 2 | 1 participants |
| Placebo | Number of Participants With Adverse Events (AEs) by Severity | Grade 3 | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 4 | 2 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 3 | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 2 | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 5 | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 1 | 7 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 3 | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 1 | 5 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 2 | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 4 | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 5 | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 5 | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 1 | 5 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 4 | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 3 | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 2 | 2 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 3 | 0 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 4 | 0 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 1 | 6 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 5 | 0 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Adverse Events (AEs) by Severity | Grade 2 | 3 participants |
Primary
Number of Participants With Anti-drug Antibodies (ADA)
The number of participants with at least one positive ADA were summarized for each treatment arm. Participants with positive antibody titer of \>4.32 milligram/milliliter (mg/mL) were considered as ADA positive.
Time frame: Baseline up to Follow-up period (Day 78)
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Only the participants who received a dose of PF-04950615 0.25, 0.50, 1.0, and 1.50 mg/kg were planned to be analysed for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Anti-drug Antibodies (ADA) | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Anti-drug Antibodies (ADA) | 1 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Anti-drug Antibodies (ADA) | 1 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Anti-drug Antibodies (ADA) | 2 participants |
Primary
Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
Criteria for clinically relevant ECG parameters: PR interval: maximum IFB of \>=25 percent or 50 percent; QRS complex: maximum IFB of \>=25 or 50 percent; QTcF interval (Fridericia's Correction): maximum IFB of \>=30 millisecond (msec) to \<60 msec and maximum IFB of \>=60 msec.
Time frame: Baseline up to Follow-up period (Day 78)
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | PR interval: Maximum IFB | 1 participants |
| Placebo | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | QRS Complex: Maximum IFB | 0 participants |
| Placebo | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | QTcF Interval: Maximum IFB >=30 to <60 msec | 0 participants |
| Placebo | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | QTcF Interval: Maximum IFB >=60 msec | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | PR interval: Maximum IFB | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | QTcF Interval: Maximum IFB >=60 msec | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | QRS Complex: Maximum IFB | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | QTcF Interval: Maximum IFB >=30 to <60 msec | 2 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | QTcF Interval: Maximum IFB >=60 msec | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | QRS Complex: Maximum IFB | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | QTcF Interval: Maximum IFB >=30 to <60 msec | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | PR interval: Maximum IFB | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | PR interval: Maximum IFB | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | QRS Complex: Maximum IFB | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | QTcF Interval: Maximum IFB >=60 msec | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | QTcF Interval: Maximum IFB >=30 to <60 msec | 1 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | QTcF Interval: Maximum IFB >=60 msec | 0 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | QTcF Interval: Maximum IFB >=30 to <60 msec | 2 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | QRS Complex: Maximum IFB | 0 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters | PR interval: Maximum IFB | 0 participants |
Primary
Number of Participants With Clinically Relevant Changes in Vital Signs
Criteria for clinically relevant vital signs: supine and standing systolic blood pressure (SBP): less than (\<) 90 millimeter of mercury (mmHg); supine and standing diastolic blood pressure (DBP): \<50 mmHg. Maximum increase from baseline (IFB) or decrease from baseline (DFB) in supine and standing SBP: greater than or equal to (\>=) 30 mmHg and maximum IFB or DFB in supine and standing DBP: \>=20 mmHg. Supine pulse rate: \<40 and greater than (\>) 120 beats per minute (bpm); standing pulse rate: \<40 and \>140 bpm.
Time frame: Baseline up to Follow-up period (Day 78)
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Clinically Relevant Changes in Vital Signs | Supine SBP | 1 participants |
| Placebo | Number of Participants With Clinically Relevant Changes in Vital Signs | Standing SBP | 1 participants |
| Placebo | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in supine DBP | 0 participants |
| Placebo | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in standing DBP | 2 participants |
| Placebo | Number of Participants With Clinically Relevant Changes in Vital Signs | Standing Pulse Rate | 0 participants |
| Placebo | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in supine DBP | 2 participants |
| Placebo | Number of Participants With Clinically Relevant Changes in Vital Signs | Supine Pulse Rate | 0 participants |
| Placebo | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in standing DBP | 1 participants |
| Placebo | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in supine SBP | 2 participants |
| Placebo | Number of Participants With Clinically Relevant Changes in Vital Signs | Standing DBP | 0 participants |
| Placebo | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in supine SBP | 1 participants |
| Placebo | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in standing SBP | 4 participants |
| Placebo | Number of Participants With Clinically Relevant Changes in Vital Signs | Supine DBP | 0 participants |
| Placebo | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in standing SBP | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in standing SBP | 2 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in supine SBP | 1 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in standing DBP | 1 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in supine DBP | 1 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in standing SBP | 2 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in standing DBP | 2 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Standing SBP | 1 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Supine SBP | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Standing Pulse Rate | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Standing DBP | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Supine DBP | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in supine DBP | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in supine SBP | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Supine Pulse Rate | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in standing SBP | 4 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Supine SBP | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in standing SBP | 1 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in supine DBP | 2 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in standing DBP | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in supine SBP | 1 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in supine DBP | 1 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in standing DBP | 3 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Standing SBP | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Supine DBP | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Standing DBP | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Supine Pulse Rate | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Standing Pulse Rate | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in supine SBP | 2 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in standing SBP | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Standing SBP | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in supine SBP | 1 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Supine DBP | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in standing DBP | 1 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Supine SBP | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Standing DBP | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in supine DBP | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Supine Pulse Rate | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in standing SBP | 1 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in supine SBP | 2 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in supine DBP | 1 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Standing Pulse Rate | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in standing DBP | 4 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in supine DBP | 1 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in supine SBP | 2 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Standing SBP | 3 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in supine SBP | 1 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in standing DBP | 0 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Supine SBP | 0 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Supine Pulse Rate | 0 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Supine DBP | 0 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in standing DBP | 1 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in standing SBP | 2 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum DFB in standing SBP | 0 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Standing Pulse Rate | 0 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Standing DBP | 0 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Clinically Relevant Changes in Vital Signs | Maximum IFB in supine DBP | 1 participants |
Primary
Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Dose limiting and intolerable treatment-related AEs were the AEs resulting from drug overdose, drug withdrawal, drug abuse, drug misuse, drug interactions, drug dependency, extravasation, exposure in utero, exposure during breast feeding.
Time frame: Baseline up to Follow-up period (Day 78)
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs) | With dose limiting treatment related AEs | 0 participants |
| Placebo | Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs) | With intolerable treatment related AEs | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs) | With dose limiting treatment related AEs | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs) | With intolerable treatment related AEs | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs) | With dose limiting treatment related AEs | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs) | With intolerable treatment related AEs | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs) | With intolerable treatment related AEs | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs) | With dose limiting treatment related AEs | 0 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs) | With dose limiting treatment related AEs | 0 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs) | With intolerable treatment related AEs | 0 participants |
Primary
Number of Participants With Laboratory Test Abnormalities
Criteria: Haemoglobin(Hgb), hematocrit, RBC: \<0.8\*lower limit of normal(LLN),mean corpuscular volume, mean corpuscular Hgb concentration \<0.9\*LLN or\>1.1\*upper limit of normal(ULN), platelet\<0.5\*LLN or\>1.75\*ULN, WBC\<0.6\*LLN or\>1.5\*ULN, lymphocyte, neutrophil\<0.8\*LLN or\>1.2\*ULN, basophil, eosinophil, monocyte\>1.2\*ULN; bilirubin\>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, lactate dehydrogenase\>3.0\*ULN,total protein,albumin\<0.8\*LLN or\>1.2\*ULN; blood urea nitrogen, creatinine\>1.3\*ULN,uric acid\>1.2\*ULN;sodium\<0.95\*LLNor\>1.05\*ULN,potassium,chloride,calcium,bicarbonate\<0.9\*LLN or\>1.1\*ULN; glucose\<0.6\*LLN or \>1.5\*ULN, urine specific gravity\<1.003 or\>1.030,urine pH\<4.5or\>8,urine glucose, ketones, urine protein,urine blood/Hgb,urobilinogen,bilirubin,nitrite, leukocyte esterase\>=1; urine RBC,WBC\>=20,urine epithelial cells\>=6,urine granular casts,hyaline casts\>1,urine bacteria\>20,partial thromboplastin time,prothrombin:\>1.1\*ULN.
Time frame: Baseline up to Follow-up period (Day 78)
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Laboratory Test Abnormalities | 7 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Laboratory Test Abnormalities | 10 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Laboratory Test Abnormalities | 2 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Laboratory Test Abnormalities | 7 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Laboratory Test Abnormalities | 7 participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs)
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 78 that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline up to Follow-up period (Day 78)
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs) | Treatment emergent AEs | 9 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs) | Treatment related AEs | 3 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs) | Treatment emergent SAEs | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs) | Treatment emergent SAEs | 1 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs) | Treatment emergent AEs | 8 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs) | Treatment related AEs | 6 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs) | Treatment emergent SAEs | 0 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs) | Treatment emergent AEs | 5 participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs) | Treatment related AEs | 3 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs) | Treatment emergent AEs | 7 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs) | Treatment related AEs | 2 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs) | Treatment emergent SAEs | 0 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs) | Treatment emergent SAEs | 0 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs) | Treatment emergent AEs | 9 participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs) | Treatment related AEs | 5 participants |
Secondary
Accumulation Ratio (Rac) of PF-04950615
Rac was calculated as Day 22 AUCtau divided by Day 1 AUCtau, where AUCtau is area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau =168 hours.
Time frame: Day 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Accumulation Ratio (Rac) of PF-04950615 | 1.261 ratio | Geometric Coefficient of Variation 12 |
| PF-04950615 0.25 mg/kg | Accumulation Ratio (Rac) of PF-04950615 | 1.685 ratio | Geometric Coefficient of Variation 11 |
| PF-04950615 0.50 mg/kg | Accumulation Ratio (Rac) of PF-04950615 | 1.771 ratio | Geometric Coefficient of Variation 16 |
| PF-04950615 1.0 mg/kg | Accumulation Ratio (Rac) of PF-04950615 | 1.964 ratio | Geometric Coefficient of Variation 9 |
Secondary
Apparent Clearance (CL) of PF-04950615
CL was calculated as Dose/AUCtau. AUCtau is area under the concentration-time profile from time zero to time tau, the dosing interval, where tau=168 hours.
Time frame: Day 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Apparent Clearance (CL) of PF-04950615 | 28.98 milliliter per hour (mL/hr) | Geometric Coefficient of Variation 19 |
| PF-04950615 0.25 mg/kg | Apparent Clearance (CL) of PF-04950615 | 18.26 milliliter per hour (mL/hr) | Geometric Coefficient of Variation 21 |
| PF-04950615 0.50 mg/kg | Apparent Clearance (CL) of PF-04950615 | 17.59 milliliter per hour (mL/hr) | Geometric Coefficient of Variation 26 |
| PF-04950615 1.0 mg/kg | Apparent Clearance (CL) of PF-04950615 | 14.05 milliliter per hour (mL/hr) | Geometric Coefficient of Variation 15 |
Secondary
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615
AUCtau is area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau =168 hours.
Time frame: Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose
Population: Pharmacokinetic (PK) parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615 | Day 1 | 596700 nanogram*hour/ milliliter (ng*h/mL) | Geometric Coefficient of Variation 13 |
| Placebo | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615 | Day 22 | 749800 nanogram*hour/ milliliter (ng*h/mL) | Geometric Coefficient of Variation 12 |
| PF-04950615 0.25 mg/kg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615 | Day 22 | 2134000 nanogram*hour/ milliliter (ng*h/mL) | Geometric Coefficient of Variation 22 |
| PF-04950615 0.25 mg/kg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615 | Day 1 | 1224000 nanogram*hour/ milliliter (ng*h/mL) | Geometric Coefficient of Variation 23 |
| PF-04950615 0.50 mg/kg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615 | Day 1 | 2697000 nanogram*hour/ milliliter (ng*h/mL) | Geometric Coefficient of Variation 14 |
| PF-04950615 0.50 mg/kg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615 | Day 22 | 4766000 nanogram*hour/ milliliter (ng*h/mL) | Geometric Coefficient of Variation 26 |
| PF-04950615 1.0 mg/kg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615 | Day 1 | 4253000 nanogram*hour/ milliliter (ng*h/mL) | Geometric Coefficient of Variation 18 |
| PF-04950615 1.0 mg/kg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615 | Day 22 | 8351000 nanogram*hour/ milliliter (ng*h/mL) | Geometric Coefficient of Variation 16 |
Secondary
Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Time frame: Baseline, Day 8, 15, 22, 36, 50, 64 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 367.42 nmol/L | Standard Deviation 251.928 |
| Placebo | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | 16.42 nmol/L | Standard Deviation 238.022 |
| Placebo | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -71.67 nmol/L | Standard Deviation 265.452 |
| Placebo | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -26.50 nmol/L | Standard Deviation 137.911 |
| Placebo | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -38.17 nmol/L | Standard Deviation 164.092 |
| Placebo | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | 18.83 nmol/L | Standard Deviation 159.906 |
| Placebo | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -45.08 nmol/L | Standard Deviation 227.314 |
| Placebo | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -50.08 nmol/L | Standard Deviation 133.655 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -198.31 nmol/L | Standard Deviation 154.965 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -70.38 nmol/L | Standard Deviation 111.722 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 424.71 nmol/L | Standard Deviation 336.502 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -162.69 nmol/L | Standard Deviation 170.876 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -135.36 nmol/L | Standard Deviation 140.673 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -31.23 nmol/L | Standard Deviation 254.307 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -93.15 nmol/L | Standard Deviation 170.77 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -114.31 nmol/L | Standard Deviation 208.922 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -79.69 nmol/L | Standard Deviation 168.66 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -108.15 nmol/L | Standard Deviation 159.176 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -237.00 nmol/L | Standard Deviation 173.93 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -177.46 nmol/L | Standard Deviation 177.244 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -173.08 nmol/L | Standard Deviation 158.586 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -138.69 nmol/L | Standard Deviation 108.767 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 578.57 nmol/L | Standard Deviation 346.792 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -236.23 nmol/L | Standard Deviation 180.758 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -163.85 nmol/L | Standard Deviation 183.861 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -248.25 nmol/L | Standard Deviation 218.091 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -271.58 nmol/L | Standard Deviation 219.097 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -244.75 nmol/L | Standard Deviation 219.917 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -226.75 nmol/L | Standard Deviation 161.785 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -85.25 nmol/L | Standard Deviation 91.821 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 459.00 nmol/L | Standard Deviation 341.699 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -147.75 nmol/L | Standard Deviation 155.138 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -311.36 nmol/L | Standard Deviation 215.078 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -215.43 nmol/L | Standard Deviation 230.488 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -297.36 nmol/L | Standard Deviation 201.235 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -341.57 nmol/L | Standard Deviation 243.742 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 639.36 nmol/L | Standard Deviation 378.728 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -337.00 nmol/L | Standard Deviation 215.72 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -219.64 nmol/L | Standard Deviation 173.835 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -333.64 nmol/L | Standard Deviation 266.184 |
Secondary
Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78
Time frame: Baseline, Day 8, 15, 22, 29 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had atleast 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Baseline | 142.67 mg/dL | Standard Deviation 20.328 |
| Placebo | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -4.00 mg/dL | Standard Deviation 16.065 |
| Placebo | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -1.00 mg/dL | Standard Deviation 14.918 |
| Placebo | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -5.50 mg/dL | Standard Deviation 12.395 |
| Placebo | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -4.58 mg/dL | Standard Deviation 12.817 |
| Placebo | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -8.92 mg/dL | Standard Deviation 11.057 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 7.96 mg/dL | Standard Deviation 12.365 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -8.81 mg/dL | Standard Deviation 24.972 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Baseline | 144.43 mg/dL | Standard Deviation 20.562 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | 13.86 mg/dL | Standard Deviation 14.032 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 5.12 mg/dL | Standard Deviation 13.477 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | 1.86 mg/dL | Standard Deviation 9.698 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 2.27 mg/dL | Standard Deviation 15.869 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 2.81 mg/dL | Standard Deviation 12.377 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Baseline | 150.39 mg/dL | Standard Deviation 20.863 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | 8.96 mg/dL | Standard Deviation 13.12 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | 0.88 mg/dL | Standard Deviation 13.167 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -6.35 mg/dL | Standard Deviation 13.842 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -3.42 mg/dL | Standard Deviation 10.025 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -1.38 mg/dL | Standard Deviation 10.776 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | 6.83 mg/dL | Standard Deviation 13.997 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -5.42 mg/dL | Standard Deviation 15.639 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 1.67 mg/dL | Standard Deviation 10.614 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Baseline | 143.46 mg/dL | Standard Deviation 25.005 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 3.68 mg/dL | Standard Deviation 16.505 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | 8.82 mg/dL | Standard Deviation 21.116 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -1.75 mg/dL | Standard Deviation 15.074 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | 2.46 mg/dL | Standard Deviation 15.163 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 6.32 mg/dL | Standard Deviation 13.546 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Baseline | 156.39 mg/dL | Standard Deviation 28.988 |
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.288395% CI: [-4.77, 15.77]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.256395% CI: [-4.51, 16.61]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.714995% CI: [-8.54, 12.37]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.44895% CI: [-6.4, 14.3]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.023195% CI: [2.06, 26.94]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.085895% CI: [-1.62, 23.87]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.24495% CI: [-5.3, 20.44]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.070295% CI: [-0.98, 24.03]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.053195% CI: [-0.13, 19.41]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.075895% CI: [-0.96, 18.83]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.696595% CI: [-8.01, 11.92]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.007195% CI: [3.83, 23.22]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.033995% CI: [0.88, 21.52]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.107595% CI: [-1.92, 19.03]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.260195% CI: [-4.54, 16.5]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.05795% CI: [-0.31, 20.24]ANCOVA
Secondary
Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78
Time frame: Baseline, Day 8, 15, 22, 29 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Baseline | 126.54 mg/dL | Standard Deviation 13.662 |
| Placebo | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -7.79 mg/dL | Standard Deviation 15.901 |
| Placebo | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -9.21 mg/dL | Standard Deviation 10.279 |
| Placebo | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -7.21 mg/dL | Standard Deviation 12.52 |
| Placebo | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -8.46 mg/dL | Standard Deviation 12.945 |
| Placebo | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -8.29 mg/dL | Standard Deviation 12.894 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -55.54 mg/dL | Standard Deviation 14.941 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -8.46 mg/dL | Standard Deviation 18.284 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Baseline | 124.04 mg/dL | Standard Deviation 16.454 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -49.11 mg/dL | Standard Deviation 15.713 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -52.54 mg/dL | Standard Deviation 13.124 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -38.39 mg/dL | Standard Deviation 8.15 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -52.38 mg/dL | Standard Deviation 14.826 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -54.08 mg/dL | Standard Deviation 14.85 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Baseline | 120.32 mg/dL | Standard Deviation 16.199 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -46.00 mg/dL | Standard Deviation 19.321 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -32.69 mg/dL | Standard Deviation 11.479 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -9.38 mg/dL | Standard Deviation 13.489 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -65.17 mg/dL | Standard Deviation 21.56 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -46.46 mg/dL | Standard Deviation 17.016 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -61.83 mg/dL | Standard Deviation 22.85 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -11.92 mg/dL | Standard Deviation 17.403 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -70.75 mg/dL | Standard Deviation 25.561 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Baseline | 125.62 mg/dL | Standard Deviation 18.377 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -63.66 mg/dL | Standard Deviation 16.555 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -56.29 mg/dL | Standard Deviation 14.567 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -41.36 mg/dL | Standard Deviation 12.796 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -39.36 mg/dL | Standard Deviation 19.171 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -59.44 mg/dL | Standard Deviation 19.275 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Baseline | 119.57 mg/dL | Standard Deviation 16.804 |
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-55.72, -29.67]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-42.93, -22.84]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-41.34, -20.26]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-50.18, -29.77]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-48.54, -28.2]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-54.73, -29.63]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-67.45, -41.67]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-64.54, -39.25]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 9595% CI: [-58.1, -36.59]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-62.24, -39.91]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-70.89, -48.89]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-67.83, -46.24]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-60.61, -37.51]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-63.48, -39.56]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-76.04, -52.4]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-71.59, -48.42]ANCOVA
Secondary
Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78
Time frame: Baseline, Day 8, 15, 22, 29 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Baseline | 46.29 mg/dL | Standard Deviation 11.696 |
| Placebo | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -1.71 mg/dL | Standard Deviation 5.211 |
| Placebo | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -2.13 mg/dL | Standard Deviation 5.05 |
| Placebo | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -0.13 mg/dL | Standard Deviation 4.354 |
| Placebo | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -0.46 mg/dL | Standard Deviation 7.149 |
| Placebo | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -1.29 mg/dL | Standard Deviation 6.315 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 3.77 mg/dL | Standard Deviation 6.559 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -1.31 mg/dL | Standard Deviation 10.355 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Baseline | 47.75 mg/dL | Standard Deviation 10.864 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | 4.39 mg/dL | Standard Deviation 5.936 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 3.31 mg/dL | Standard Deviation 4.671 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | 0.18 mg/dL | Standard Deviation 5.052 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 2.54 mg/dL | Standard Deviation 6.28 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 2.46 mg/dL | Standard Deviation 7.304 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Baseline | 52.89 mg/dL | Standard Deviation 12.837 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | 2.23 mg/dL | Standard Deviation 3.93 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | 0.23 mg/dL | Standard Deviation 3.908 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -1.46 mg/dL | Standard Deviation 4.832 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 0.17 mg/dL | Standard Deviation 4.499 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -0.92 mg/dL | Standard Deviation 4.821 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | 1.58 mg/dL | Standard Deviation 7.141 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -0.25 mg/dL | Standard Deviation 5.586 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 0.92 mg/dL | Standard Deviation 7.122 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Baseline | 49.23 mg/dL | Standard Deviation 14.621 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 5.36 mg/dL | Standard Deviation 4.483 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | 2.21 mg/dL | Standard Deviation 6.83 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | 0.00 mg/dL | Standard Deviation 5.349 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | 5.14 mg/dL | Standard Deviation 6.443 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 4.79 mg/dL | Standard Deviation 7.122 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Baseline | 55.64 mg/dL | Standard Deviation 15.687 |
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.306495% CI: [-1.89, 5.9]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.192295% CI: [-1.38, 6.73]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.682795% CI: [-3.16, 4.79]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.221195% CI: [-1.52, 6.42]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.003395% CI: [2.31, 10.97]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.026995% CI: [0.6, 9.57]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.08995% CI: [-0.61, 8.34]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.024295% CI: [0.69, 9.47]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.12795% CI: [-0.95, 7.46]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.119995% CI: [-0.91, 7.7]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.812395% CI: [-3.79, 4.82]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.009595% CI: [1.44, 9.87]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.114195% CI: [-0.99, 8.99]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.155295% CI: [-1.42, 8.73]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.540795% CI: [-3.53, 6.67]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.010795% CI: [1.58, 11.53]ANCOVA
Secondary
Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78
Time frame: Baseline, Day 8, 15, 22, 29 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Baseline | 191.46 mg/dL | Standard Deviation 20.999 |
| Placebo | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -6.96 mg/dL | Standard Deviation 10.212 |
| Placebo | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -9.21 mg/dL | Standard Deviation 21.912 |
| Placebo | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -7.46 mg/dL | Standard Deviation 24.362 |
| Placebo | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -14.21 mg/dL | Standard Deviation 13.327 |
| Placebo | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | 0.04 mg/dL | Standard Deviation 22.738 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -87.23 mg/dL | Standard Deviation 19.842 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -10.08 mg/dL | Standard Deviation 28.522 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Baseline | 185.46 mg/dL | Standard Deviation 26.89 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -81.82 mg/dL | Standard Deviation 22.163 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -88.31 mg/dL | Standard Deviation 20.754 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -61.46 mg/dL | Standard Deviation 17.091 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -92.35 mg/dL | Standard Deviation 21.685 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -90.81 mg/dL | Standard Deviation 25.136 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Baseline | 186.46 mg/dL | Standard Deviation 29.171 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -73.19 mg/dL | Standard Deviation 31.471 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -52.19 mg/dL | Standard Deviation 16.982 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -10.42 mg/dL | Standard Deviation 19.339 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -112.25 mg/dL | Standard Deviation 35.962 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -76.23 mg/dL | Standard Deviation 27.03 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -99.25 mg/dL | Standard Deviation 34.162 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -16.17 mg/dL | Standard Deviation 33.701 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -117.67 mg/dL | Standard Deviation 45.816 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Baseline | 193.31 mg/dL | Standard Deviation 34.922 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -109.50 mg/dL | Standard Deviation 28.156 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -97.00 mg/dL | Standard Deviation 25.07 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -71.50 mg/dL | Standard Deviation 29.506 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -68.79 mg/dL | Standard Deviation 43.324 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -104.93 mg/dL | Standard Deviation 28.08 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Baseline | 191.57 mg/dL | Standard Deviation 26.355 |
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-76.74, -43.97]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-69.45, -35.61]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-86.06, -52.86]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-82.55, -49.94]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-100.05, -56.87]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-93.43, -49.13]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-113.92, -69.74]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-111.03, -67.97]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-103.73, -69.72]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-109.57, -74.8]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-123.34, -88.78]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-115.95, -82.4]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-96.22, -61.93]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-101.4, -66.39]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-122.13, -87.35]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-113.89, -80.11]ANCOVA
Secondary
Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78
Time frame: Baseline, Day 8, 15, 22, 29 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -1.25 mg/dL | Standard Deviation 19.76 |
| Placebo | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -14.67 mg/dL | Standard Deviation 17.127 |
| Placebo | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -8.67 mg/dL | Standard Deviation 12.841 |
| Placebo | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Baseline | 237.75 mg/dL | Standard Deviation 24.94 |
| Placebo | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -11.33 mg/dL | Standard Deviation 23.714 |
| Placebo | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -7.58 mg/dL | Standard Deviation 24.265 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -61.29 mg/dL | Standard Deviation 18.605 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -11.38 mg/dL | Standard Deviation 31.685 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -85.00 mg/dL | Standard Deviation 21.184 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -77.43 mg/dL | Standard Deviation 22.27 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -83.46 mg/dL | Standard Deviation 23.107 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Baseline | 233.21 mg/dL | Standard Deviation 26.471 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -70.96 mg/dL | Standard Deviation 30.673 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -51.96 mg/dL | Standard Deviation 18.394 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Baseline | 239.36 mg/dL | Standard Deviation 32.827 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -89.81 mg/dL | Standard Deviation 23.173 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -11.88 mg/dL | Standard Deviation 20.431 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -88.35 mg/dL | Standard Deviation 26.534 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -116.75 mg/dL | Standard Deviation 46.591 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -16.42 mg/dL | Standard Deviation 35.522 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -77.15 mg/dL | Standard Deviation 28.981 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -97.67 mg/dL | Standard Deviation 35.386 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -112.08 mg/dL | Standard Deviation 36.393 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Baseline | 242.54 mg/dL | Standard Deviation 31.408 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -63.64 mg/dL | Standard Deviation 40.832 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -71.50 mg/dL | Standard Deviation 28.657 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -94.79 mg/dL | Standard Deviation 24.196 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -100.14 mg/dL | Standard Deviation 26.658 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -104.14 mg/dL | Standard Deviation 26.623 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Baseline | 247.21 mg/dL | Standard Deviation 24.41 |
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-100.96, -59.37]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-75.54, -34.29]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-65.21, -22.94]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-88.92, -47.05]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-81.11, -39.9]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-89.02, -47.76]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-81.54, -39.27]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-107.74, -65.46]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-101.73, -60.52]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-104.14, -61.87]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-125.91, -83.62]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-110.84, -69.63]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-92.34, -50.75]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-95.59, -53.32]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-123.49, -81.21]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-107.76, -66.55]ANCOVA
Secondary
Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78
Time frame: Baseline, Day 8, 15, 22, 29 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Baseline | 152.92 mg/dL | Standard Deviation 52.761 |
| Placebo | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | 4.33 mg/dL | Standard Deviation 53.163 |
| Placebo | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -4.92 mg/dL | Standard Deviation 47.001 |
| Placebo | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 7.75 mg/dL | Standard Deviation 39.352 |
| Placebo | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -3.00 mg/dL | Standard Deviation 43.389 |
| Placebo | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | 52.33 mg/dL | Standard Deviation 177.35 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -24.23 mg/dL | Standard Deviation 36.103 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -1.77 mg/dL | Standard Deviation 52.488 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Baseline | 152.00 mg/dL | Standard Deviation 55.166 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -19.00 mg/dL | Standard Deviation 32.268 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -17.62 mg/dL | Standard Deviation 45.629 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -12.21 mg/dL | Standard Deviation 52.707 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -3.54 mg/dL | Standard Deviation 39.199 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -14.38 mg/dL | Standard Deviation 53.705 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Baseline | 130.36 mg/dL | Standard Deviation 41.199 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -13.92 mg/dL | Standard Deviation 44.051 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -15.69 mg/dL | Standard Deviation 41.689 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -1.00 mg/dL | Standard Deviation 35.576 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -45.29 mg/dL | Standard Deviation 82.959 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -32.35 mg/dL | Standard Deviation 52.814 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -23.54 mg/dL | Standard Deviation 40.176 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | 12.21 mg/dL | Standard Deviation 108.874 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -60.21 mg/dL | Standard Deviation 102.224 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Baseline | 182.27 mg/dL | Standard Deviation 117.963 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -26.25 mg/dL | Standard Deviation 29.632 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -16.32 mg/dL | Standard Deviation 32.999 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -2.18 mg/dL | Standard Deviation 66.044 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -18.25 mg/dL | Standard Deviation 40.93 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -13.75 mg/dL | Standard Deviation 47.976 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Baseline | 137.96 mg/dL | Standard Deviation 70.799 |
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.44895% CI: [-80.08, 35.49]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.280995% CI: [-91.8, 26.76]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.287595% CI: [-90.9, 27.07]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.574395% CI: [-74.38, 41.33]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.499795% CI: [-77.62, 37.96]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.475695% CI: [-80.78, 37.78]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.56195% CI: [-77.73, 42.26]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.466795% CI: [-79.27, 36.44]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.304595% CI: [-89.45, 28.06]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.430195% CI: [-83.06, 35.5]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.088195% CI: [-112.15, 7.85]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.284495% CI: [-89.36, 26.35]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.374195% CI: [-85.32, 32.19]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.428395% CI: [-83.16, 35.4]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.065795% CI: [-116.31, 3.68]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.258695% CI: [-91.11, 24.6]ANCOVA
Secondary
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78
Time frame: Baseline, Day 8, 15, 22, 29 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had atleast 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Baseline | 160.96 milligram per deciliter (mg/dL) | Standard Deviation 19.447 |
| Placebo | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -6.59 milligram per deciliter (mg/dL) | Standard Deviation 11.258 |
| Placebo | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -8.21 milligram per deciliter (mg/dL) | Standard Deviation 20.192 |
| Placebo | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -8.96 milligram per deciliter (mg/dL) | Standard Deviation 21.416 |
| Placebo | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -13.71 milligram per deciliter (mg/dL) | Standard Deviation 17.24 |
| Placebo | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -4.36 milligram per deciliter (mg/dL) | Standard Deviation 21.969 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -82.50 milligram per deciliter (mg/dL) | Standard Deviation 20.848 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -9.73 milligram per deciliter (mg/dL) | Standard Deviation 19.796 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Baseline | 155.04 milligram per deciliter (mg/dL) | Standard Deviation 18.501 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -77.96 milligram per deciliter (mg/dL) | Standard Deviation 22.181 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -84.81 milligram per deciliter (mg/dL) | Standard Deviation 17.345 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -58.89 milligram per deciliter (mg/dL) | Standard Deviation 16.313 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -91.69 milligram per deciliter (mg/dL) | Standard Deviation 20.718 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -88.00 milligram per deciliter (mg/dL) | Standard Deviation 25.267 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Baseline | 160.39 milligram per deciliter (mg/dL) | Standard Deviation 27.326 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -70.38 milligram per deciliter (mg/dL) | Standard Deviation 25.583 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -49.08 milligram per deciliter (mg/dL) | Standard Deviation 12.708 |
| PF-04950615 0.50 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -10.15 milligram per deciliter (mg/dL) | Standard Deviation 14.174 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -101.92 milligram per deciliter (mg/dL) | Standard Deviation 26.974 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -68.54 milligram per deciliter (mg/dL) | Standard Deviation 27.477 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -93.25 milligram per deciliter (mg/dL) | Standard Deviation 31.287 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -14.09 milligram per deciliter (mg/dL) | Standard Deviation 38.162 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -104.33 milligram per deciliter (mg/dL) | Standard Deviation 35.026 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Baseline | 155.62 milligram per deciliter (mg/dL) | Standard Deviation 23.393 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -104.21 milligram per deciliter (mg/dL) | Standard Deviation 26.207 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -93.79 milligram per deciliter (mg/dL) | Standard Deviation 23.841 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -67.96 milligram per deciliter (mg/dL) | Standard Deviation 27.754 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -65.14 milligram per deciliter (mg/dL) | Standard Deviation 39.5 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -102.21 milligram per deciliter (mg/dL) | Standard Deviation 27.277 |
| PF-04950615 1.50 mg/kg | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Baseline | 164.00 milligram per deciliter (mg/dL) | Standard Deviation 21.729 |
Comparison: Day 8: Analysis was performed using the analysis of covariance (ANCOVA) treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-71.37, -37.99]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-61.28, -27.08]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-81.35, -47.53]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-78.36, -45.15]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-92.4, -51.92]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-84.59, -43.19]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-109.39, -68]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-104.76, -64.54]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-96.22, -60.71]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-102.51, -66.4]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-114.12, -78.03]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-109.8, -74.86]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-90.51, -52.3]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-95.37, -56.65]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-113.18, -74.38]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-108.35, -70.81]ANCOVA
Secondary
Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Time frame: Baseline, Day 8, 15, 22, 36, 50, 64 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 20.37 nanometer (nm) | Standard Deviation 0.713 |
| Placebo | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | 0.00 nanometer (nm) | Standard Deviation 0.6 |
| Placebo | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -0.23 nanometer (nm) | Standard Deviation 0.661 |
| Placebo | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -0.05 nanometer (nm) | Standard Deviation 0.403 |
| Placebo | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -0.13 nanometer (nm) | Standard Deviation 0.382 |
| Placebo | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -0.04 nanometer (nm) | Standard Deviation 0.487 |
| Placebo | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -0.19 nanometer (nm) | Standard Deviation 0.601 |
| Placebo | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -0.13 nanometer (nm) | Standard Deviation 0.367 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -0.13 nanometer (nm) | Standard Deviation 0.403 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -0.08 nanometer (nm) | Standard Deviation 0.285 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 20.48 nanometer (nm) | Standard Deviation 0.833 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | 0.24 nanometer (nm) | Standard Deviation 0.333 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | 0.07 nanometer (nm) | Standard Deviation 0.334 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | 0.11 nanometer (nm) | Standard Deviation 0.551 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | 0.01 nanometer (nm) | Standard Deviation 0.352 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -0.19 nanometer (nm) | Standard Deviation 0.413 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -0.18 nanometer (nm) | Standard Deviation 0.426 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -0.15 nanometer (nm) | Standard Deviation 0.533 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | 0.10 nanometer (nm) | Standard Deviation 0.567 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -0.18 nanometer (nm) | Standard Deviation 0.463 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | 0.19 nanometer (nm) | Standard Deviation 0.463 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | 0.06 nanometer (nm) | Standard Deviation 0.399 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 21.04 nanometer (nm) | Standard Deviation 1.059 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | 0.22 nanometer (nm) | Standard Deviation 0.518 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -0.02 nanometer (nm) | Standard Deviation 0.446 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -0.08 nanometer (nm) | Standard Deviation 0.496 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | 0.08 nanometer (nm) | Standard Deviation 0.564 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | 0.07 nanometer (nm) | Standard Deviation 0.509 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -0.02 nanometer (nm) | Standard Deviation 0.327 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -0.09 nanometer (nm) | Standard Deviation 0.323 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 20.66 nanometer (nm) | Standard Deviation 1.018 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -0.08 nanometer (nm) | Standard Deviation 0.379 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | 0.08 nanometer (nm) | Standard Deviation 0.507 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | 0.08 nanometer (nm) | Standard Deviation 0.435 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | 0.05 nanometer (nm) | Standard Deviation 0.372 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | 0.04 nanometer (nm) | Standard Deviation 0.497 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 21.18 nanometer (nm) | Standard Deviation 1.132 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | 0.11 nanometer (nm) | Standard Deviation 0.595 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | 0.09 nanometer (nm) | Standard Deviation 0.38 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | 0.09 nanometer (nm) | Standard Deviation 0.766 |
Secondary
Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Time frame: Baseline, Day 8, 15, 22, 36, 50, 64 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 302.67 nmol/L | Standard Deviation 103.271 |
| Placebo | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -45.33 nmol/L | Standard Deviation 77.296 |
| Placebo | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -17.92 nmol/L | Standard Deviation 90.062 |
| Placebo | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -17.33 nmol/L | Standard Deviation 72.118 |
| Placebo | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -26.58 nmol/L | Standard Deviation 70.37 |
| Placebo | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -7.42 nmol/L | Standard Deviation 67.594 |
| Placebo | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -7.50 nmol/L | Standard Deviation 91.363 |
| Placebo | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -12.25 nmol/L | Standard Deviation 53.177 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -88.15 nmol/L | Standard Deviation 85.983 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | 16.77 nmol/L | Standard Deviation 46.49 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 257.57 nmol/L | Standard Deviation 98.358 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -113.54 nmol/L | Standard Deviation 84.567 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -70.71 nmol/L | Standard Deviation 66.675 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -2.69 nmol/L | Standard Deviation 76.234 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -39.85 nmol/L | Standard Deviation 75.66 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | 32.69 nmol/L | Standard Deviation 52.454 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | 16.08 nmol/L | Standard Deviation 54.92 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | 18.23 nmol/L | Standard Deviation 84.81 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -77.54 nmol/L | Standard Deviation 104.141 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -1.23 nmol/L | Standard Deviation 63.816 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -83.85 nmol/L | Standard Deviation 91.519 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -52.77 nmol/L | Standard Deviation 77.953 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 196.57 nmol/L | Standard Deviation 128.296 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -103.46 nmol/L | Standard Deviation 96.958 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -89.62 nmol/L | Standard Deviation 96.271 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -105.25 nmol/L | Standard Deviation 124.532 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -126.50 nmol/L | Standard Deviation 134.014 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -128.83 nmol/L | Standard Deviation 128.898 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -76.00 nmol/L | Standard Deviation 105.963 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -5.08 nmol/L | Standard Deviation 77.809 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 237.31 nmol/L | Standard Deviation 135.958 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -18.75 nmol/L | Standard Deviation 63.438 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -95.93 nmol/L | Standard Deviation 80.612 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -54.79 nmol/L | Standard Deviation 59.832 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -83.29 nmol/L | Standard Deviation 70.268 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -75.14 nmol/L | Standard Deviation 84.82 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 171.14 nmol/L | Standard Deviation 114.37 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -89.57 nmol/L | Standard Deviation 89.102 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -58.00 nmol/L | Standard Deviation 69.471 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -95.93 nmol/L | Standard Deviation 75.083 |
Secondary
Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Time frame: Baseline, Day 8, 15, 22, 36, 50, 64 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | 35.58 nanomoles per liter (nmol/L) | Standard Deviation 410.428 |
| Placebo | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -17.25 nanomoles per liter (nmol/L) | Standard Deviation 256.9 |
| Placebo | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -21.08 nanomoles per liter (nmol/L) | Standard Deviation 348.697 |
| Placebo | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -62.92 nanomoles per liter (nmol/L) | Standard Deviation 369.272 |
| Placebo | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -58.92 nanomoles per liter (nmol/L) | Standard Deviation 273.321 |
| Placebo | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 1436.42 nanomoles per liter (nmol/L) | Standard Deviation 476.114 |
| Placebo | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | 38.58 nanomoles per liter (nmol/L) | Standard Deviation 341.805 |
| Placebo | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -104.67 nanomoles per liter (nmol/L) | Standard Deviation 421.388 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | 19.31 nanomoles per liter (nmol/L) | Standard Deviation 136.299 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -665.23 nanomoles per liter (nmol/L) | Standard Deviation 392.357 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | 102.15 nanomoles per liter (nmol/L) | Standard Deviation 222.45 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -245.77 nanomoles per liter (nmol/L) | Standard Deviation 326.908 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -521.15 nanomoles per liter (nmol/L) | Standard Deviation 397.925 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -70.92 nanomoles per liter (nmol/L) | Standard Deviation 356.896 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -435.86 nanomoles per liter (nmol/L) | Standard Deviation 323.733 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 1285.21 nanomoles per liter (nmol/L) | Standard Deviation 510.295 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -304.85 nanomoles per liter (nmol/L) | Standard Deviation 390.365 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -450.31 nanomoles per liter (nmol/L) | Standard Deviation 458.385 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 982.14 nanomoles per liter (nmol/L) | Standard Deviation 660.248 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -450.85 nanomoles per liter (nmol/L) | Standard Deviation 531.247 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -88.15 nanomoles per liter (nmol/L) | Standard Deviation 311.715 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -534.62 nanomoles per liter (nmol/L) | Standard Deviation 480.776 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | 60.00 nanomoles per liter (nmol/L) | Standard Deviation 245.038 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | 39.00 nanomoles per liter (nmol/L) | Standard Deviation 417.482 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -697.50 nanomoles per liter (nmol/L) | Standard Deviation 565.896 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -57.33 nanomoles per liter (nmol/L) | Standard Deviation 364.799 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -165.33 nanomoles per liter (nmol/L) | Standard Deviation 302.403 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -567.67 nanomoles per liter (nmol/L) | Standard Deviation 533.371 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 1163.69 nanomoles per liter (nmol/L) | Standard Deviation 625.676 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -450.17 nanomoles per liter (nmol/L) | Standard Deviation 475.951 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -696.42 nanomoles per liter (nmol/L) | Standard Deviation 589.692 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -459.31 nanomoles per liter (nmol/L) | Standard Deviation 379.905 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -299.43 nanomoles per liter (nmol/L) | Standard Deviation 315.715 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 870.07 nanomoles per liter (nmol/L) | Standard Deviation 564.004 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -321.71 nanomoles per liter (nmol/L) | Standard Deviation 311.16 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -470.93 nanomoles per liter (nmol/L) | Standard Deviation 348.889 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -513.07 nanomoles per liter (nmol/L) | Standard Deviation 392.796 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -540.93 nanomoles per liter (nmol/L) | Standard Deviation 394.389 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -514.64 nanomoles per liter (nmol/L) | Standard Deviation 444.216 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -441.29 nanomoles per liter (nmol/L) | Standard Deviation 420.139 |
Secondary
Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Time frame: Baseline, Day 8, 15, 22, 36, 50, 64 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 1898.83 nmol/L | Standard Deviation 393.934 |
| Placebo | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -100.42 nmol/L | Standard Deviation 326.272 |
| Placebo | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -87.67 nmol/L | Standard Deviation 269.313 |
| Placebo | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -89.17 nmol/L | Standard Deviation 344.1 |
| Placebo | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -113.58 nmol/L | Standard Deviation 299.598 |
| Placebo | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | 63.00 nmol/L | Standard Deviation 303.42 |
| Placebo | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -0.33 nmol/L | Standard Deviation 287.226 |
| Placebo | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -60.83 nmol/L | Standard Deviation 285.233 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -756.46 nmol/L | Standard Deviation 300.314 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -45.23 nmol/L | Standard Deviation 128.264 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 1789.29 nmol/L | Standard Deviation 297.035 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -877.62 nmol/L | Standard Deviation 276.218 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -598.00 nmol/L | Standard Deviation 253.302 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -105.62 nmol/L | Standard Deviation 319.186 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -345.46 nmol/L | Standard Deviation 272.208 |
| PF-04950615 0.25 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | 10.62 nmol/L | Standard Deviation 191.872 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -14.77 nmol/L | Standard Deviation 231.884 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -72.69 nmol/L | Standard Deviation 364.42 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -735.92 nmol/L | Standard Deviation 462.348 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -278.23 nmol/L | Standard Deviation 268.441 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -658.08 nmol/L | Standard Deviation 400.172 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -460.08 nmol/L | Standard Deviation 351.468 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 1626.14 nmol/L | Standard Deviation 474.106 |
| PF-04950615 0.50 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -805.46 nmol/L | Standard Deviation 413.417 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -664.00 nmol/L | Standard Deviation 332.371 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -851.67 nmol/L | Standard Deviation 447.423 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -1015.00 nmol/L | Standard Deviation 482.252 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -986.75 nmol/L | Standard Deviation 466.474 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -705.00 nmol/L | Standard Deviation 486.227 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -143.42 nmol/L | Standard Deviation 432.459 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 1694.15 nmol/L | Standard Deviation 439.012 |
| PF-04950615 1.0 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -309.25 nmol/L | Standard Deviation 396.535 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 22 | -846.71 nmol/L | Standard Deviation 303.019 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 78 | -529.57 nmol/L | Standard Deviation 294.496 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 15 | -790.14 nmol/L | Standard Deviation 269.961 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 64 | -801.36 nmol/L | Standard Deviation 354.429 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 1549.71 nmol/L | Standard Deviation 332.241 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 50 | -879.50 nmol/L | Standard Deviation 322.993 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 8 | -557.86 nmol/L | Standard Deviation 245.049 |
| PF-04950615 1.50 mg/kg | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Change at Day 36 | -894.21 nmol/L | Standard Deviation 284.814 |
Secondary
C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78
Time frame: Day 8, 15, 21, 36, 57 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had atleast 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 8 | 0.23 mg/dL | Standard Deviation 0.252 |
| Placebo | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 15 | 0.30 mg/dL | Standard Deviation 0.385 |
| Placebo | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 21 | 0.27 mg/dL | Standard Deviation 0.32 |
| Placebo | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 36 | 0.34 mg/dL | Standard Deviation 0.407 |
| Placebo | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 57 | 0.21 mg/dL | Standard Deviation 0.205 |
| Placebo | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 78 | 0.32 mg/dL | Standard Deviation 0.4 |
| PF-04950615 0.25 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 57 | 0.36 mg/dL | Standard Deviation 0.502 |
| PF-04950615 0.25 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 78 | 0.33 mg/dL | Standard Deviation 0.522 |
| PF-04950615 0.25 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 8 | 0.26 mg/dL | Standard Deviation 0.204 |
| PF-04950615 0.25 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 21 | 0.23 mg/dL | Standard Deviation 0.194 |
| PF-04950615 0.25 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 36 | 0.27 mg/dL | Standard Deviation 0.255 |
| PF-04950615 0.25 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 15 | 0.23 mg/dL | Standard Deviation 0.206 |
| PF-04950615 0.50 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 36 | 0.27 mg/dL | Standard Deviation 0.45 |
| PF-04950615 0.50 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 57 | 0.21 mg/dL | Standard Deviation 0.368 |
| PF-04950615 0.50 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 8 | 0.18 mg/dL | Standard Deviation 0.251 |
| PF-04950615 0.50 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 21 | 0.23 mg/dL | Standard Deviation 0.441 |
| PF-04950615 0.50 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 15 | 0.25 mg/dL | Standard Deviation 0.433 |
| PF-04950615 0.50 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 78 | 0.21 mg/dL | Standard Deviation 0.291 |
| PF-04950615 1.0 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 36 | 0.28 mg/dL | Standard Deviation 0.306 |
| PF-04950615 1.0 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 15 | 0.38 mg/dL | Standard Deviation 0.553 |
| PF-04950615 1.0 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 21 | 0.32 mg/dL | Standard Deviation 0.464 |
| PF-04950615 1.0 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 78 | 0.54 mg/dL | Standard Deviation 1.175 |
| PF-04950615 1.0 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 57 | 0.51 mg/dL | Standard Deviation 0.985 |
| PF-04950615 1.0 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 8 | 0.42 mg/dL | Standard Deviation 0.506 |
| PF-04950615 1.50 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 57 | 0.18 mg/dL | Standard Deviation 0.22 |
| PF-04950615 1.50 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 21 | 0.21 mg/dL | Standard Deviation 0.364 |
| PF-04950615 1.50 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 15 | 0.20 mg/dL | Standard Deviation 0.293 |
| PF-04950615 1.50 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 78 | 0.15 mg/dL | Standard Deviation 0.141 |
| PF-04950615 1.50 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 36 | 0.26 mg/dL | Standard Deviation 0.541 |
| PF-04950615 1.50 mg/kg | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | Day 8 | 0.16 mg/dL | Standard Deviation 0.191 |
Secondary
High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Time frame: Day 8, 15, 22, 36, 50, 64 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 8.73 nm | Standard Deviation 0.454 |
| Placebo | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 8.75 nm | Standard Deviation 0.406 |
| Placebo | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 8.73 nm | Standard Deviation 0.379 |
| Placebo | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 8.68 nm | Standard Deviation 0.339 |
| Placebo | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 8.75 nm | Standard Deviation 0.303 |
| Placebo | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 8.73 nm | Standard Deviation 0.398 |
| Placebo | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 8.72 nm | Standard Deviation 0.356 |
| PF-04950615 0.25 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 8.85 nm | Standard Deviation 0.369 |
| PF-04950615 0.25 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 8.81 nm | Standard Deviation 0.359 |
| PF-04950615 0.25 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 8.75 nm | Standard Deviation 0.364 |
| PF-04950615 0.25 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 8.84 nm | Standard Deviation 0.331 |
| PF-04950615 0.25 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 8.77 nm | Standard Deviation 0.384 |
| PF-04950615 0.25 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 8.77 nm | Standard Deviation 0.307 |
| PF-04950615 0.25 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 8.76 nm | Standard Deviation 0.263 |
| PF-04950615 0.50 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 9.05 nm | Standard Deviation 0.484 |
| PF-04950615 0.50 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 8.98 nm | Standard Deviation 0.419 |
| PF-04950615 0.50 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 9.06 nm | Standard Deviation 0.371 |
| PF-04950615 0.50 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 9.02 nm | Standard Deviation 0.421 |
| PF-04950615 0.50 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 9.05 nm | Standard Deviation 0.47 |
| PF-04950615 0.50 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 8.99 nm | Standard Deviation 0.362 |
| PF-04950615 0.50 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 9.01 nm | Standard Deviation 0.441 |
| PF-04950615 1.0 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 8.92 nm | Standard Deviation 0.471 |
| PF-04950615 1.0 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 9.03 nm | Standard Deviation 0.479 |
| PF-04950615 1.0 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 8.95 nm | Standard Deviation 0.547 |
| PF-04950615 1.0 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 8.88 nm | Standard Deviation 0.513 |
| PF-04950615 1.0 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 8.99 nm | Standard Deviation 0.507 |
| PF-04950615 1.0 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 8.96 nm | Standard Deviation 0.571 |
| PF-04950615 1.0 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 8.95 nm | Standard Deviation 0.427 |
| PF-04950615 1.50 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 9.08 nm | Standard Deviation 0.395 |
| PF-04950615 1.50 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 8.96 nm | Standard Deviation 0.386 |
| PF-04950615 1.50 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 9.01 nm | Standard Deviation 0.427 |
| PF-04950615 1.50 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 9.04 nm | Standard Deviation 0.403 |
| PF-04950615 1.50 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 9.04 nm | Standard Deviation 0.425 |
| PF-04950615 1.50 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 9.07 nm | Standard Deviation 0.412 |
| PF-04950615 1.50 mg/kg | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 9.09 nm | Standard Deviation 0.342 |
Secondary
Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Time frame: Day 8, 15, 22, 36, 50, 64 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 5.88 umol/L | Standard Deviation 3.636 |
| Placebo | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 5.17 umol/L | Standard Deviation 2.934 |
| Placebo | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 5.78 umol/L | Standard Deviation 3.155 |
| Placebo | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 6.23 umol/L | Standard Deviation 3.497 |
| Placebo | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 5.90 umol/L | Standard Deviation 3.514 |
| Placebo | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 5.70 umol/L | Standard Deviation 2.763 |
| Placebo | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 5.95 umol/L | Standard Deviation 3.293 |
| PF-04950615 0.25 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 5.98 umol/L | Standard Deviation 3.452 |
| PF-04950615 0.25 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 6.97 umol/L | Standard Deviation 4.091 |
| PF-04950615 0.25 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 6.11 umol/L | Standard Deviation 3.684 |
| PF-04950615 0.25 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 6.81 umol/L | Standard Deviation 3.963 |
| PF-04950615 0.25 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 5.98 umol/L | Standard Deviation 2.471 |
| PF-04950615 0.25 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 6.85 umol/L | Standard Deviation 3.152 |
| PF-04950615 0.25 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 5.61 umol/L | Standard Deviation 2.271 |
| PF-04950615 0.50 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 8.25 umol/L | Standard Deviation 4.123 |
| PF-04950615 0.50 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 7.97 umol/L | Standard Deviation 3.491 |
| PF-04950615 0.50 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 9.05 umol/L | Standard Deviation 3.604 |
| PF-04950615 0.50 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 7.93 umol/L | Standard Deviation 3.943 |
| PF-04950615 0.50 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 7.58 umol/L | Standard Deviation 4.065 |
| PF-04950615 0.50 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 7.47 umol/L | Standard Deviation 3.564 |
| PF-04950615 0.50 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 7.74 umol/L | Standard Deviation 3.788 |
| PF-04950615 1.0 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 6.75 umol/L | Standard Deviation 3.544 |
| PF-04950615 1.0 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 7.90 umol/L | Standard Deviation 4.608 |
| PF-04950615 1.0 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 7.03 umol/L | Standard Deviation 3.833 |
| PF-04950615 1.0 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 7.16 umol/L | Standard Deviation 4.958 |
| PF-04950615 1.0 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 7.41 umol/L | Standard Deviation 5.359 |
| PF-04950615 1.0 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 6.87 umol/L | Standard Deviation 4.608 |
| PF-04950615 1.0 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 7.74 umol/L | Standard Deviation 4.124 |
| PF-04950615 1.50 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 8.88 umol/L | Standard Deviation 4.919 |
| PF-04950615 1.50 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 8.56 umol/L | Standard Deviation 3.747 |
| PF-04950615 1.50 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 7.65 umol/L | Standard Deviation 2.848 |
| PF-04950615 1.50 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 9.06 umol/L | Standard Deviation 4.073 |
| PF-04950615 1.50 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 8.36 umol/L | Standard Deviation 3.815 |
| PF-04950615 1.50 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 8.08 umol/L | Standard Deviation 4.144 |
| PF-04950615 1.50 mg/kg | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 8.94 umol/L | Standard Deviation 3.656 |
Secondary
Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Time frame: Day 8, 15, 22, 36, 50, 64 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 4.66 nmol/L | Standard Deviation 7.571 |
| Placebo | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 9.00 nmol/L | Standard Deviation 15.067 |
| Placebo | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 8.41 nmol/L | Standard Deviation 12.714 |
| Placebo | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 4.07 nmol/L | Standard Deviation 4.367 |
| Placebo | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 2.84 nmol/L | Standard Deviation 3.086 |
| Placebo | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 6.72 nmol/L | Standard Deviation 7.795 |
| Placebo | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 5.93 nmol/L | Standard Deviation 6.572 |
| PF-04950615 0.25 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 3.25 nmol/L | Standard Deviation 2.712 |
| PF-04950615 0.25 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 3.85 nmol/L | Standard Deviation 3.261 |
| PF-04950615 0.25 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 3.69 nmol/L | Standard Deviation 3.202 |
| PF-04950615 0.25 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 3.91 nmol/L | Standard Deviation 3.291 |
| PF-04950615 0.25 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 3.42 nmol/L | Standard Deviation 3.224 |
| PF-04950615 0.25 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 3.65 nmol/L | Standard Deviation 3.692 |
| PF-04950615 0.25 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 4.08 nmol/L | Standard Deviation 3.494 |
| PF-04950615 0.50 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 2.17 nmol/L | Standard Deviation 2.615 |
| PF-04950615 0.50 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 2.43 nmol/L | Standard Deviation 3.119 |
| PF-04950615 0.50 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 2.36 nmol/L | Standard Deviation 2.425 |
| PF-04950615 0.50 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 2.52 nmol/L | Standard Deviation 3.384 |
| PF-04950615 0.50 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 2.47 nmol/L | Standard Deviation 3.347 |
| PF-04950615 0.50 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 2.13 nmol/L | Standard Deviation 3.096 |
| PF-04950615 0.50 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 2.34 nmol/L | Standard Deviation 2.993 |
| PF-04950615 1.0 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 2.75 nmol/L | Standard Deviation 2.821 |
| PF-04950615 1.0 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 5.57 nmol/L | Standard Deviation 7.217 |
| PF-04950615 1.0 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 5.58 nmol/L | Standard Deviation 6.071 |
| PF-04950615 1.0 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 6.68 nmol/L | Standard Deviation 9.279 |
| PF-04950615 1.0 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 6.33 nmol/L | Standard Deviation 8.829 |
| PF-04950615 1.0 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 5.18 nmol/L | Standard Deviation 5.91 |
| PF-04950615 1.0 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 4.27 nmol/L | Standard Deviation 3.359 |
| PF-04950615 1.50 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 4.01 nmol/L | Standard Deviation 7.348 |
| PF-04950615 1.50 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 2.89 nmol/L | Standard Deviation 3.806 |
| PF-04950615 1.50 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 2.51 nmol/L | Standard Deviation 3.305 |
| PF-04950615 1.50 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 3.31 nmol/L | Standard Deviation 4.728 |
| PF-04950615 1.50 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 3.19 nmol/L | Standard Deviation 4.364 |
| PF-04950615 1.50 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 4.63 nmol/L | Standard Deviation 8.128 |
| PF-04950615 1.50 mg/kg | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 3.91 nmol/L | Standard Deviation 6.648 |
Secondary
Maximum Observed Plasma Concentration (Cmax) of PF-04950615
Time frame: Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | Day 1 | 8077 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 19 |
| Placebo | Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | Day 22 | 10170 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 11 |
| PF-04950615 0.25 mg/kg | Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | Day 22 | 23680 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 50 |
| PF-04950615 0.25 mg/kg | Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | Day 1 | 15080 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 20 |
| PF-04950615 0.50 mg/kg | Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | Day 1 | 31380 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 13 |
| PF-04950615 0.50 mg/kg | Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | Day 22 | 45820 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 17 |
| PF-04950615 1.0 mg/kg | Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | Day 1 | 45110 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 15 |
| PF-04950615 1.0 mg/kg | Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | Day 22 | 76180 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 15 |
Secondary
Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Time frame: Day 8, 15, 22, 36, 50, 64 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 1.90 umol/L | Standard Deviation 2.158 |
| Placebo | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 3.65 umol/L | Standard Deviation 3.592 |
| Placebo | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 3.50 umol/L | Standard Deviation 3.254 |
| Placebo | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 3.26 umol/L | Standard Deviation 2.394 |
| Placebo | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 2.80 umol/L | Standard Deviation 2.888 |
| Placebo | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 4.29 umol/L | Standard Deviation 3.516 |
| Placebo | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 3.68 umol/L | Standard Deviation 3.615 |
| PF-04950615 0.25 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 3.48 umol/L | Standard Deviation 2.869 |
| PF-04950615 0.25 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 4.75 umol/L | Standard Deviation 3.583 |
| PF-04950615 0.25 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 4.88 umol/L | Standard Deviation 2.467 |
| PF-04950615 0.25 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 4.24 umol/L | Standard Deviation 3.086 |
| PF-04950615 0.25 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 2.82 umol/L | Standard Deviation 2.722 |
| PF-04950615 0.25 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 5.60 umol/L | Standard Deviation 3.836 |
| PF-04950615 0.25 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 3.28 umol/L | Standard Deviation 3.006 |
| PF-04950615 0.50 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 5.31 umol/L | Standard Deviation 3.738 |
| PF-04950615 0.50 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 5.12 umol/L | Standard Deviation 3.778 |
| PF-04950615 0.50 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 4.82 umol/L | Standard Deviation 3.408 |
| PF-04950615 0.50 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 6.81 umol/L | Standard Deviation 5.102 |
| PF-04950615 0.50 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 3.28 umol/L | Standard Deviation 3.059 |
| PF-04950615 0.50 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 3.74 umol/L | Standard Deviation 3.358 |
| PF-04950615 0.50 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 2.88 umol/L | Standard Deviation 3.098 |
| PF-04950615 1.0 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 5.71 umol/L | Standard Deviation 3.563 |
| PF-04950615 1.0 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 4.94 umol/L | Standard Deviation 3.596 |
| PF-04950615 1.0 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 8.69 umol/L | Standard Deviation 5.054 |
| PF-04950615 1.0 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 4.19 umol/L | Standard Deviation 4.274 |
| PF-04950615 1.0 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 4.73 umol/L | Standard Deviation 3.772 |
| PF-04950615 1.0 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 6.24 umol/L | Standard Deviation 4.067 |
| PF-04950615 1.0 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 8.34 umol/L | Standard Deviation 6.035 |
| PF-04950615 1.50 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 7.08 umol/L | Standard Deviation 6.606 |
| PF-04950615 1.50 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 5.37 umol/L | Standard Deviation 6.117 |
| PF-04950615 1.50 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 7.04 umol/L | Standard Deviation 6.034 |
| PF-04950615 1.50 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 7.50 umol/L | Standard Deviation 7.664 |
| PF-04950615 1.50 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 5.84 umol/L | Standard Deviation 6.642 |
| PF-04950615 1.50 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 5.29 umol/L | Standard Deviation 5.057 |
| PF-04950615 1.50 mg/kg | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 6.06 umol/L | Standard Deviation 4.5 |
Secondary
Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Time frame: Day 8, 15, 22, 36, 50, 64 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 43.84 nmol/L | Standard Deviation 31.72 |
| Placebo | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 31.68 nmol/L | Standard Deviation 26.579 |
| Placebo | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 46.29 nmol/L | Standard Deviation 48.067 |
| Placebo | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 42.08 nmol/L | Standard Deviation 30.055 |
| Placebo | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 45.18 nmol/L | Standard Deviation 33.883 |
| Placebo | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 54.42 nmol/L | Standard Deviation 43.631 |
| Placebo | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 40.91 nmol/L | Standard Deviation 29.614 |
| PF-04950615 0.25 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 39.62 nmol/L | Standard Deviation 26.49 |
| PF-04950615 0.25 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 38.26 nmol/L | Standard Deviation 25.474 |
| PF-04950615 0.25 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 29.93 nmol/L | Standard Deviation 12.067 |
| PF-04950615 0.25 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 31.89 nmol/L | Standard Deviation 16.142 |
| PF-04950615 0.25 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 35.02 nmol/L | Standard Deviation 23.457 |
| PF-04950615 0.25 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 32.32 nmol/L | Standard Deviation 16.184 |
| PF-04950615 0.25 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 33.54 nmol/L | Standard Deviation 19.946 |
| PF-04950615 0.50 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 19.35 nmol/L | Standard Deviation 9.353 |
| PF-04950615 0.50 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 21.82 nmol/L | Standard Deviation 12.659 |
| PF-04950615 0.50 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 31.38 nmol/L | Standard Deviation 25.58 |
| PF-04950615 0.50 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 35.10 nmol/L | Standard Deviation 20.188 |
| PF-04950615 0.50 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 25.31 nmol/L | Standard Deviation 19.813 |
| PF-04950615 0.50 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 21.05 nmol/L | Standard Deviation 16.456 |
| PF-04950615 0.50 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 30.74 nmol/L | Standard Deviation 24.781 |
| PF-04950615 1.0 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 39.47 nmol/L | Standard Deviation 22.121 |
| PF-04950615 1.0 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 34.01 nmol/L | Standard Deviation 20.44 |
| PF-04950615 1.0 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 34.84 nmol/L | Standard Deviation 26.305 |
| PF-04950615 1.0 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 38.25 nmol/L | Standard Deviation 33.529 |
| PF-04950615 1.0 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 38.27 nmol/L | Standard Deviation 28.436 |
| PF-04950615 1.0 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 32.02 nmol/L | Standard Deviation 20.966 |
| PF-04950615 1.0 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 29.31 nmol/L | Standard Deviation 18.029 |
| PF-04950615 1.50 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 30.62 nmol/L | Standard Deviation 17.768 |
| PF-04950615 1.50 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 30.55 nmol/L | Standard Deviation 35.729 |
| PF-04950615 1.50 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 24.48 nmol/L | Standard Deviation 15.117 |
| PF-04950615 1.50 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 25.04 nmol/L | Standard Deviation 19.77 |
| PF-04950615 1.50 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 33.91 nmol/L | Standard Deviation 26.636 |
| PF-04950615 1.50 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 34.56 nmol/L | Standard Deviation 28.586 |
| PF-04950615 1.50 mg/kg | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 26.48 nmol/L | Standard Deviation 18.798 |
Secondary
Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL)
Time frame: Day 15, 22, 29 and 36
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 15 | 0 Participants |
| Placebo | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 29 | 0 Participants |
| Placebo | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 36 | 0 Participants |
| Placebo | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 22 | 0 Participants |
| PF-04950615 0.25 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 22 | 12 Participants |
| PF-04950615 0.25 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 29 | 12 Participants |
| PF-04950615 0.25 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 15 | 13 Participants |
| PF-04950615 0.25 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 36 | 2 Participants |
| PF-04950615 0.50 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 15 | 10 Participants |
| PF-04950615 0.50 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 22 | 11 Participants |
| PF-04950615 0.50 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 29 | 11 Participants |
| PF-04950615 0.50 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 36 | 11 Participants |
| PF-04950615 1.0 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 22 | 12 Participants |
| PF-04950615 1.0 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 29 | 12 Participants |
| PF-04950615 1.0 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 15 | 11 Participants |
| PF-04950615 1.0 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 36 | 12 Participants |
| PF-04950615 1.50 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 22 | 12 Participants |
| PF-04950615 1.50 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 36 | 12 Participants |
| PF-04950615 1.50 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 29 | 13 Participants |
| PF-04950615 1.50 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | Day 15 | 12 Participants |
Comparison: Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.001395% CI: [9.95, 12528.19]Regression, Logistic
Comparison: Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.004795% CI: [4.44, 3808.21]Regression, Logistic
Comparison: Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.001895% CI: [8.35, 10787.45]Regression, Logistic
Comparison: Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.002595% CI: [6.34, 5743.12]Regression, Logistic
Comparison: Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.001895% CI: [7.87, 8290.22]Regression, Logistic
Comparison: Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.003495% CI: [5.28, 4291.89]Regression, Logistic
Comparison: Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.001895% CI: [11.6, 47929.45]Regression, Logistic
Comparison: Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.003195% CI: [5.4, 3963.01]Regression, Logistic
Comparison: Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.00295% CI: [7.13, 6396.64]Regression, Logistic
Comparison: Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.003895% CI: [4.73, 3277.13]Regression, Logistic
Comparison: Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.00295% CI: [10.51, 36846.03]Regression, Logistic
Comparison: Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.001795% CI: [7.63, 6598]Regression, Logistic
Comparison: Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.275195% CI: [0.24, 161.08]Regression, Logistic
Comparison: Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.003895% CI: [5.05, 4633.92]Regression, Logistic
Comparison: Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.00295% CI: [11.18, 51133.53]Regression, Logistic
Comparison: Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.002195% CI: [7.53, 8902.61]Regression, Logistic
Secondary
Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL)
Time frame: Day 15, 22, 29 and 36
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 15 | 0 Participants |
| Placebo | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 22 | 0 Participants |
| Placebo | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 29 | 0 Participants |
| Placebo | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 36 | 0 Participants |
| PF-04950615 0.25 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 15 | 6 Participants |
| PF-04950615 0.25 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 36 | 0 Participants |
| PF-04950615 0.25 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 22 | 8 Participants |
| PF-04950615 0.25 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 29 | 6 Participants |
| PF-04950615 0.50 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 36 | 7 Participants |
| PF-04950615 0.50 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 22 | 8 Participants |
| PF-04950615 0.50 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 29 | 6 Participants |
| PF-04950615 0.50 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 15 | 3 Participants |
| PF-04950615 1.0 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 15 | 7 Participants |
| PF-04950615 1.0 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 22 | 8 Participants |
| PF-04950615 1.0 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 36 | 8 Participants |
| PF-04950615 1.0 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 29 | 9 Participants |
| PF-04950615 1.50 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 36 | 8 Participants |
| PF-04950615 1.50 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 29 | 10 Participants |
| PF-04950615 1.50 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 22 | 10 Participants |
| PF-04950615 1.50 mg/kg | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | Day 15 | 8 Participants |
Comparison: Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.047295% CI: [1.04, 599.65]Regression, Logistic
Comparison: Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.136895% CI: [0.46, 305.54]Regression, Logistic
Comparison: Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.01995% CI: [1.89, 1198.29]Regression, Logistic
Comparison: Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.019295% CI: [1.86, 1103.73]Regression, Logistic
Comparison: Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.010595% CI: [2.74, 2014.67]Regression, Logistic
Comparison: Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.008695% CI: [3.1, 2389.27]Regression, Logistic
Comparison: Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.008495% CI: [3.14, 2449.11]Regression, Logistic
Comparison: Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.005395% CI: [4.07, 3097.22]Regression, Logistic
Comparison: Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.040395% CI: [1.16, 662.2]Regression, Logistic
Comparison: Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.036195% CI: [1.25, 733.32]Regression, Logistic
Comparison: Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.006995% CI: [3.43, 2326.44]Regression, Logistic
Comparison: Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.008195% CI: [3.08, 1875.15]Regression, Logistic
Comparison: Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.993195% CI: [0.02, 64.41]Regression, Logistic
Comparison: Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.025995% CI: [1.55, 975.84]Regression, Logistic
Comparison: Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.014295% CI: [2.26, 1477.88]Regression, Logistic
Comparison: Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.017995% CI: [1.95, 1216.9]Regression, Logistic
Secondary
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in LDL-C From Baseline
Time frame: Baseline, Day 15, 22, 29 and 36
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in LDL-C From Baseline | 0 Participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in LDL-C From Baseline | 0 Participants |
| PF-04950615 0.50 mg/kg | Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in LDL-C From Baseline | 5 Participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in LDL-C From Baseline | 8 Participants |
| PF-04950615 1.50 mg/kg | Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in LDL-C From Baseline | 8 Participants |
Comparison: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.95895% CI: [0.02, 52.79]Regression, Logistic
Comparison: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.073295% CI: [0.76, 394.65]Regression, Logistic
Comparison: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.015995% CI: [2.07, 1109.11]Regression, Logistic
Comparison: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.p-value: 0.026495% CI: [1.51, 733.62]Regression, Logistic
Secondary
Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78
Time frame: Day 8, 15, 22, 29 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -2.62 percent change | Standard Deviation 8.538 |
| Placebo | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -2.15 percent change | Standard Deviation 10.895 |
| Placebo | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -5.85 percent change | Standard Deviation 7.27 |
| Placebo | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -0.18 percent change | Standard Deviation 10.362 |
| Placebo | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -3.38 percent change | Standard Deviation 8.315 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 5.82 percent change | Standard Deviation 8.244 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 4.01 percent change | Standard Deviation 9.735 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | 10.03 percent change | Standard Deviation 10.615 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -4.61 percent change | Standard Deviation 15.035 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | 1.38 percent change | Standard Deviation 6.508 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 1.90 percent change | Standard Deviation 10.085 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | 0.55 percent change | Standard Deviation 8.065 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | 5.67 percent change | Standard Deviation 8.409 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 1.80 percent change | Standard Deviation 8.623 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -3.48 percent change | Standard Deviation 9.082 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -3.77 percent change | Standard Deviation 10.868 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -1.17 percent change | Standard Deviation 7.549 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 1.20 percent change | Standard Deviation 7.435 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -1.61 percent change | Standard Deviation 6.994 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | 4.99 percent change | Standard Deviation 9.45 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 4.92 percent change | Standard Deviation 9.366 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 3.51 percent change | Standard Deviation 11.179 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -0.19 percent change | Standard Deviation 9.462 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | 3.20 percent change | Standard Deviation 11.505 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | 6.11 percent change | Standard Deviation 14.252 |
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.332695% CI: [-3.49, 10.14]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.296795% CI: [-3.32, 10.7]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.881295% CI: [-6.42, 7.46]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.322795% CI: [-3.45, 10.3]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.02195% CI: [1.56, 18.46]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.119295% CI: [-1.82, 15.49]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.252995% CI: [-3.69, 13.78]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.072595% CI: [-0.73, 16.25]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.040595% CI: [0.3, 13.18]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.059395% CI: [-0.25, 12.8]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.593695% CI: [-4.81, 8.33]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.003495% CI: [3.38, 16.17]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.030595% CI: [0.74, 14.46]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.125295% CI: [-1.55, 12.37]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.292395% CI: [-3.28, 10.71]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.029795% CI: [0.78, 14.43]ANCOVA
Secondary
Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78
Time frame: Day 8, 15, 22, 29 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -6.61 percent change | Standard Deviation 10.206 |
| Placebo | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -5.78 percent change | Standard Deviation 12.548 |
| Placebo | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -6.24 percent change | Standard Deviation 10.119 |
| Placebo | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -7.08 percent change | Standard Deviation 7.974 |
| Placebo | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -5.17 percent change | Standard Deviation 9.548 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -44.37 percent change | Standard Deviation 10.311 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -42.06 percent change | Standard Deviation 8.865 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -39.63 percent change | Standard Deviation 11.339 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -6.11 percent change | Standard Deviation 13.75 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -31.37 percent change | Standard Deviation 7.019 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -43.87 percent change | Standard Deviation 10.909 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -27.78 percent change | Standard Deviation 9.784 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -38.94 percent change | Standard Deviation 15.373 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -45.51 percent change | Standard Deviation 12.176 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -7.95 percent change | Standard Deviation 11.527 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -8.40 percent change | Standard Deviation 13.819 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -36.61 percent change | Standard Deviation 12.248 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -55.74 percent change | Standard Deviation 15.477 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -51.52 percent change | Standard Deviation 12.657 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -49.03 percent change | Standard Deviation 15.663 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -49.45 percent change | Standard Deviation 13.498 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -53.15 percent change | Standard Deviation 10.682 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -34.71 percent change | Standard Deviation 9.872 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -33.66 percent change | Standard Deviation 17.828 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -47.45 percent change | Standard Deviation 12.424 |
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-34.59, -18.1]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-32.95, -15.63]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-39.58, -22.83]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-38.78, -22.08]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-43.42, -23.19]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-44.65, -23.63]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-52.96, -32.18]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-52.07, -31.67]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-46.46, -29.05]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-50.04, -31.93]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-55.88, -38.08]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-54.52, -37.03]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-47.85, -29.37]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-50.78, -31.6]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-59.2, -40.3]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-57.33, -38.76]ANCOVA
Secondary
Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78
Time frame: Day 8, 15, 22, 29 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 0.02 percent change | Standard Deviation 14.389 |
| Placebo | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -2.75 percent change | Standard Deviation 11.363 |
| Placebo | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -1.40 percent change | Standard Deviation 13.662 |
| Placebo | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -3.98 percent change | Standard Deviation 10.134 |
| Placebo | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 0.48 percent change | Standard Deviation 9.693 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 9.02 percent change | Standard Deviation 14.218 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 8.01 percent change | Standard Deviation 10.268 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | 10.54 percent change | Standard Deviation 14.406 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | 0.24 percent change | Standard Deviation 19.628 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | 1.26 percent change | Standard Deviation 10.469 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 5.49 percent change | Standard Deviation 11.126 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | 0.31 percent change | Standard Deviation 7.401 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | 4.72 percent change | Standard Deviation 8.025 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 4.55 percent change | Standard Deviation 12.03 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -2.24 percent change | Standard Deviation 8.9 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -2.32 percent change | Standard Deviation 11.31 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -2.64 percent change | Standard Deviation 9.055 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 3.56 percent change | Standard Deviation 12.87 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 1.78 percent change | Standard Deviation 9.431 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | 4.39 percent change | Standard Deviation 11.643 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 9.83 percent change | Standard Deviation 14.119 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | 11.44 percent change | Standard Deviation 10.27 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | 0.61 percent change | Standard Deviation 10.217 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | 11.35 percent change | Standard Deviation 13.124 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | 5.56 percent change | Standard Deviation 13.089 |
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.26995% CI: [-3.53, 12.41]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.212295% CI: [-3.07, 13.5]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.895395% CI: [-7.59, 8.67]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.172395% CI: [-2.51, 13.7]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.00195% CI: [6.34, 23.56]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.017995% CI: [1.95, 19.78]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.046295% CI: [0.16, 17.96]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.009195% CI: [3.05, 20.52]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.077495% CI: [-0.83, 15.45]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.090995% CI: [-1.18, 15.5]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.610795% CI: [-6.2, 10.45]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.006295% CI: [3.42, 19.75]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.070295% CI: [-0.74, 18.13]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.169295% CI: [-2.93, 16.32]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.375195% CI: [-5.34, 13.96]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.005395% CI: [4.23, 23.08]ANCOVA
Secondary
Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78
Time frame: Day 8, 15, 22, 29 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -7.45 percent change | Standard Deviation 7.261 |
| Placebo | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -3.85 percent change | Standard Deviation 5.557 |
| Placebo | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -0.13 percent change | Standard Deviation 11.797 |
| Placebo | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -4.33 percent change | Standard Deviation 11.789 |
| Placebo | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -3.27 percent change | Standard Deviation 12.091 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -46.96 percent change | Standard Deviation 8.425 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -47.43 percent change | Standard Deviation 7.666 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -44.54 percent change | Standard Deviation 12.261 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -4.84 percent change | Standard Deviation 14.681 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -33.32 percent change | Standard Deviation 8.161 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -50.15 percent change | Standard Deviation 10.327 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -28.56 percent change | Standard Deviation 8.868 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -40.54 percent change | Standard Deviation 15.915 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -49.29 percent change | Standard Deviation 12.89 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -5.97 percent change | Standard Deviation 10.711 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -6.62 percent change | Standard Deviation 16.96 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -39.11 percent change | Standard Deviation 12.195 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -59.12 percent change | Standard Deviation 15.643 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -57.08 percent change | Standard Deviation 10.801 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -50.81 percent change | Standard Deviation 14.32 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -54.61 percent change | Standard Deviation 11.948 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -56.98 percent change | Standard Deviation 10.994 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -36.85 percent change | Standard Deviation 11.918 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -36.83 percent change | Standard Deviation 24.401 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -50.85 percent change | Standard Deviation 12.789 |
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-38.56, -22.72]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-34.8, -18.44]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-43.29, -27.24]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-41.3, -25.54]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-52.34, -30.42]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-49.36, -26.88]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-58.64, -36.2]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-57.87, -36]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-53.96, -36.77]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-57.58, -39.99]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-63.23, -45.75]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-60.25, -43.26]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-49.58, -32.07]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-52.68, -34.81]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-61.25, -43.48]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-58.58, -41.31]ANCOVA
Secondary
Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78
Time frame: Day 8, 15, 22, 29 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -6.12 percent change | Standard Deviation 7.275 |
| Placebo | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -3.73 percent change | Standard Deviation 5.594 |
| Placebo | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -0.90 percent change | Standard Deviation 8.32 |
| Placebo | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -4.46 percent change | Standard Deviation 10.151 |
| Placebo | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -2.61 percent change | Standard Deviation 9.708 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -35.76 percent change | Standard Deviation 8.855 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -36.44 percent change | Standard Deviation 7.736 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -33.35 percent change | Standard Deviation 9.238 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -4.28 percent change | Standard Deviation 13.04 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -26.43 percent change | Standard Deviation 7.582 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -37.81 percent change | Standard Deviation 9.438 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -22.11 percent change | Standard Deviation 8.292 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -30.59 percent change | Standard Deviation 13.208 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -37.12 percent change | Standard Deviation 11.045 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -5.11 percent change | Standard Deviation 8.907 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -5.49 percent change | Standard Deviation 14.026 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -31.68 percent change | Standard Deviation 11.543 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -46.81 percent change | Standard Deviation 15.606 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -45.23 percent change | Standard Deviation 11.101 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -39.69 percent change | Standard Deviation 13.307 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -40.69 percent change | Standard Deviation 10.542 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -42.24 percent change | Standard Deviation 9.692 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -28.70 percent change | Standard Deviation 10.002 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -26.16 percent change | Standard Deviation 17.561 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -38.77 percent change | Standard Deviation 10.906 |
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-31.06, -14.34]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-27.17, -10.03]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-36.46, -19.49]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-33.24, -16.54]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-37.25, -20.53]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-34.92, -17.79]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-44.46, -27.33]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-42.58, -25.88]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-42.39, -25.53]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-43.98, -26.85]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-51.85, -34.71]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-46.35, -29.65]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-38.19, -21.34]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-39.79, -22.65]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-49.91, -32.78]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-44.39, -27.69]ANCOVA
Secondary
Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78
Time frame: Day 8, 15, 22, 29 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -6.35 percent change | Standard Deviation 24.168 |
| Placebo | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -2.25 percent change | Standard Deviation 30.696 |
| Placebo | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | 35.06 percent change | Standard Deviation 123.074 |
| Placebo | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -1.76 percent change | Standard Deviation 38.074 |
| Placebo | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | 5.29 percent change | Standard Deviation 25.939 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -15.68 percent change | Standard Deviation 17.89 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -9.14 percent change | Standard Deviation 24.192 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -9.97 percent change | Standard Deviation 19.639 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | 4.27 percent change | Standard Deviation 33.925 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | 0.47 percent change | Standard Deviation 36.664 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -2.82 percent change | Standard Deviation 31.72 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -9.47 percent change | Standard Deviation 33.634 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -8.88 percent change | Standard Deviation 29.664 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -13.18 percent change | Standard Deviation 39.826 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -2.18 percent change | Standard Deviation 32.081 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | 4.74 percent change | Standard Deviation 43.369 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -15.52 percent change | Standard Deviation 25.106 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -19.81 percent change | Standard Deviation 34.9 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -13.00 percent change | Standard Deviation 28.724 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -8.87 percent change | Standard Deviation 16.916 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -8.11 percent change | Standard Deviation 31.027 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -18.32 percent change | Standard Deviation 21.062 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -1.90 percent change | Standard Deviation 35.794 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -12.42 percent change | Standard Deviation 28.128 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -8.36 percent change | Standard Deviation 32.603 |
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.978995% CI: [-39.08, 38.04]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.552595% CI: [-51.46, 27.59]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.503595% CI: [-52.73, 25.96]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.830295% CI: [-42.81, 34.39]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.55995% CI: [-50.01, 27.1]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.555895% CI: [-51.36, 27.69]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.683595% CI: [-48.34, 31.74]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.569995% CI: [-49.75, 27.45]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.382695% CI: [-56.64, 21.8]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.523395% CI: [-52.35, 26.7]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.339195% CI: [-59.51, 20.57]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.360695% CI: [-56.55, 20.65]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.536495% CI: [-51.55, 26.89]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.565195% CI: [-51.08, 27.96]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.471995% CI: [-54.69, 25.39]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: 0.399995% CI: [-55.13, 22.07]ANCOVA
Secondary
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78
Time frame: Day 8, 15, 22, 29 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -8.72 percent change | Standard Deviation 11.074 |
| Placebo | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -4.15 percent change | Standard Deviation 6.983 |
| Placebo | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -2.97 percent change | Standard Deviation 13.71 |
| Placebo | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -4.39 percent change | Standard Deviation 12.713 |
| Placebo | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -4.94 percent change | Standard Deviation 12.826 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -52.96 percent change | Standard Deviation 11.416 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -54.66 percent change | Standard Deviation 9.14 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -50.68 percent change | Standard Deviation 14.566 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -5.87 percent change | Standard Deviation 12.391 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -38.53 percent change | Standard Deviation 11.399 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -58.12 percent change | Standard Deviation 13.891 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -31.59 percent change | Standard Deviation 10.032 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -45.47 percent change | Standard Deviation 17.016 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -55.25 percent change | Standard Deviation 15.133 |
| PF-04950615 0.50 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -6.50 percent change | Standard Deviation 9.229 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -6.94 percent change | Standard Deviation 22.385 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -44.24 percent change | Standard Deviation 17.213 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -65.50 percent change | Standard Deviation 17.327 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -64.59 percent change | Standard Deviation 13.826 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -59.42 percent change | Standard Deviation 19.934 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 22 | -62.78 percent change | Standard Deviation 16.665 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 29 | -63.85 percent change | Standard Deviation 14.416 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 8 | -40.72 percent change | Standard Deviation 14.21 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 78 | -40.47 percent change | Standard Deviation 25.797 |
| PF-04950615 1.50 mg/kg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | Change at Day 15 | -58.02 percent change | Standard Deviation 16.265 |
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-43.99, -23.65]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-38.35, -17.51]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-49.89, -29.28]ANCOVA
Comparison: Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-47.75, -27.51]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-58.78, -33.2]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-54.9, -28.74]ANCOVA
Comparison: Day 15: Analysis was performed using ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-69.43, -43.27]ANCOVA
Comparison: Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-66.17, -40.74]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-60.7, -38.64]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-65.14, -42.7]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-71.81, -49.38]ANCOVA
Comparison: Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-68.53, -46.8]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-55.8, -32.57]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-59.06, -35.5]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-69.53, -45.94]ANCOVA
Comparison: Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.p-value: <0.000195% CI: [-66.38, -43.54]ANCOVA
Secondary
Plasma Decay Half-Life (t1/2) of PF-04950615
t1/2 was the time measured for the plasma concentration of PF-04950615 to decrease by one half. t1/2 was calculated as Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Plasma Decay Half-Life (t1/2) of PF-04950615 | Day 1 | 50.39 hour | Standard Deviation 6.4231 |
| Placebo | Plasma Decay Half-Life (t1/2) of PF-04950615 | Day 22 | 94.24 hour | Standard Deviation 57.042 |
| PF-04950615 0.25 mg/kg | Plasma Decay Half-Life (t1/2) of PF-04950615 | Day 22 | 140.4 hour | Standard Deviation 45.61 |
| PF-04950615 0.50 mg/kg | Plasma Decay Half-Life (t1/2) of PF-04950615 | Day 1 | 71.50 hour | — |
| PF-04950615 0.50 mg/kg | Plasma Decay Half-Life (t1/2) of PF-04950615 | Day 22 | 155.6 hour | Standard Deviation 38.503 |
| PF-04950615 1.0 mg/kg | Plasma Decay Half-Life (t1/2) of PF-04950615 | Day 22 | 247.2 hour | Standard Deviation 85.361 |
Secondary
Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78
Time frame: Baseline, Day 8, 15, 22, 36, 50, 64 and 78
Population: Pharmacodynamic analysis population was defined as all enrolled participants who received at least 1 dose of study medication and had atleast 1 pharmacodynamic parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 48.83 ng/mL | Standard Deviation 22.741 |
| Placebo | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 48.53 ng/mL | Standard Deviation 21.549 |
| Placebo | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 50.42 ng/mL | Standard Deviation 22.17 |
| Placebo | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 52.58 ng/mL | Standard Deviation 29.516 |
| Placebo | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 51.80 ng/mL | Standard Deviation 24.231 |
| Placebo | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 48.21 ng/mL | Standard Deviation 19.973 |
| Placebo | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 51.95 ng/mL | Standard Deviation 25.584 |
| Placebo | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 43.75 ng/mL | Standard Deviation 23.686 |
| PF-04950615 0.25 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | NA ng/mL | — |
| PF-04950615 0.25 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | NA ng/mL | — |
| PF-04950615 0.25 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 43.96 ng/mL | Standard Deviation 23.731 |
| PF-04950615 0.25 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | NA ng/mL | — |
| PF-04950615 0.25 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | NA ng/mL | — |
| PF-04950615 0.25 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | NA ng/mL | — |
| PF-04950615 0.25 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | NA ng/mL | — |
| PF-04950615 0.25 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | NA ng/mL | — |
| PF-04950615 0.50 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | NA ng/mL | — |
| PF-04950615 0.50 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | NA ng/mL | — |
| PF-04950615 0.50 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | NA ng/mL | — |
| PF-04950615 0.50 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | NA ng/mL | — |
| PF-04950615 0.50 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | NA ng/mL | — |
| PF-04950615 0.50 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | NA ng/mL | — |
| PF-04950615 0.50 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 43.07 ng/mL | Standard Deviation 23.58 |
| PF-04950615 0.50 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | NA ng/mL | — |
| PF-04950615 1.0 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | NA ng/mL | — |
| PF-04950615 1.0 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | NA ng/mL | — |
| PF-04950615 1.0 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | NA ng/mL | — |
| PF-04950615 1.0 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | NA ng/mL | — |
| PF-04950615 1.0 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | NA ng/mL | — |
| PF-04950615 1.0 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | NA ng/mL | — |
| PF-04950615 1.0 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 34.10 ng/mL | Standard Deviation 20.316 |
| PF-04950615 1.0 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | NA ng/mL | — |
| PF-04950615 1.50 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | NA ng/mL | — |
| PF-04950615 1.50 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | NA ng/mL | — |
| PF-04950615 1.50 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | NA ng/mL | — |
| PF-04950615 1.50 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | NA ng/mL | — |
| PF-04950615 1.50 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Baseline | 44.12 ng/mL | Standard Deviation 24.425 |
| PF-04950615 1.50 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | NA ng/mL | — |
| PF-04950615 1.50 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | NA ng/mL | — |
| PF-04950615 1.50 mg/kg | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | NA ng/mL | — |
Secondary
Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Time frame: Day 8, 15, 22, 36, 50, 64 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had atleast 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 23.26 micromole/liter (umol/L) | Standard Deviation 3.147 |
| Placebo | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 22.79 micromole/liter (umol/L) | Standard Deviation 4.176 |
| Placebo | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 25.13 micromole/liter (umol/L) | Standard Deviation 4.747 |
| Placebo | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 22.74 micromole/liter (umol/L) | Standard Deviation 5.162 |
| Placebo | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 23.13 micromole/liter (umol/L) | Standard Deviation 5.511 |
| Placebo | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 23.16 micromole/liter (umol/L) | Standard Deviation 5.582 |
| Placebo | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 23.25 micromole/liter (umol/L) | Standard Deviation 3.395 |
| PF-04950615 0.25 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 23.73 micromole/liter (umol/L) | Standard Deviation 4.924 |
| PF-04950615 0.25 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 23.33 micromole/liter (umol/L) | Standard Deviation 5.223 |
| PF-04950615 0.25 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 24.04 micromole/liter (umol/L) | Standard Deviation 3.831 |
| PF-04950615 0.25 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 22.79 micromole/liter (umol/L) | Standard Deviation 3.21 |
| PF-04950615 0.25 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 23.02 micromole/liter (umol/L) | Standard Deviation 6.617 |
| PF-04950615 0.25 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 23.67 micromole/liter (umol/L) | Standard Deviation 4.626 |
| PF-04950615 0.25 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 22.25 micromole/liter (umol/L) | Standard Deviation 6.245 |
| PF-04950615 0.50 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 21.72 micromole/liter (umol/L) | Standard Deviation 5.804 |
| PF-04950615 0.50 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 20.64 micromole/liter (umol/L) | Standard Deviation 7.39 |
| PF-04950615 0.50 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 22.39 micromole/liter (umol/L) | Standard Deviation 6.412 |
| PF-04950615 0.50 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 21.60 micromole/liter (umol/L) | Standard Deviation 6.865 |
| PF-04950615 0.50 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 23.37 micromole/liter (umol/L) | Standard Deviation 5.005 |
| PF-04950615 0.50 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 22.89 micromole/liter (umol/L) | Standard Deviation 5.298 |
| PF-04950615 0.50 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 21.85 micromole/liter (umol/L) | Standard Deviation 5.61 |
| PF-04950615 1.0 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 21.57 micromole/liter (umol/L) | Standard Deviation 6.763 |
| PF-04950615 1.0 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 22.83 micromole/liter (umol/L) | Standard Deviation 6.103 |
| PF-04950615 1.0 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 19.04 micromole/liter (umol/L) | Standard Deviation 5.768 |
| PF-04950615 1.0 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 20.16 micromole/liter (umol/L) | Standard Deviation 5.633 |
| PF-04950615 1.0 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 20.73 micromole/liter (umol/L) | Standard Deviation 5.579 |
| PF-04950615 1.0 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 19.74 micromole/liter (umol/L) | Standard Deviation 5.807 |
| PF-04950615 1.0 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 19.18 micromole/liter (umol/L) | Standard Deviation 6.676 |
| PF-04950615 1.50 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 21.02 micromole/liter (umol/L) | Standard Deviation 6.531 |
| PF-04950615 1.50 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 21.11 micromole/liter (umol/L) | Standard Deviation 6.976 |
| PF-04950615 1.50 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 22.92 micromole/liter (umol/L) | Standard Deviation 7.777 |
| PF-04950615 1.50 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 22.61 micromole/liter (umol/L) | Standard Deviation 8.649 |
| PF-04950615 1.50 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 21.87 micromole/liter (umol/L) | Standard Deviation 7.229 |
| PF-04950615 1.50 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 21.49 micromole/liter (umol/L) | Standard Deviation 5.767 |
| PF-04950615 1.50 mg/kg | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 22.59 micromole/liter (umol/L) | Standard Deviation 5.06 |
Secondary
Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Time frame: Day 8, 15, 22, 36, 50, 64 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 48.02 nmol/L | Standard Deviation 19.76 |
| Placebo | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 50.44 nmol/L | Standard Deviation 24.319 |
| Placebo | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 51.82 nmol/L | Standard Deviation 22.057 |
| Placebo | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 50.14 nmol/L | Standard Deviation 17.239 |
| Placebo | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 54.04 nmol/L | Standard Deviation 18.566 |
| Placebo | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 55.32 nmol/L | Standard Deviation 16.242 |
| Placebo | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 50.04 nmol/L | Standard Deviation 19.344 |
| PF-04950615 0.25 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 57.12 nmol/L | Standard Deviation 20.032 |
| PF-04950615 0.25 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 44.25 nmol/L | Standard Deviation 18.962 |
| PF-04950615 0.25 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 30.55 nmol/L | Standard Deviation 13.832 |
| PF-04950615 0.25 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 38.97 nmol/L | Standard Deviation 17.319 |
| PF-04950615 0.25 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 57.12 nmol/L | Standard Deviation 22.475 |
| PF-04950615 0.25 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 28.86 nmol/L | Standard Deviation 11.54 |
| PF-04950615 0.25 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 48.44 nmol/L | Standard Deviation 15.108 |
| PF-04950615 0.50 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 24.22 nmol/L | Standard Deviation 15.588 |
| PF-04950615 0.50 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 36.84 nmol/L | Standard Deviation 16.561 |
| PF-04950615 0.50 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 29.98 nmol/L | Standard Deviation 22.143 |
| PF-04950615 0.50 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 20.91 nmol/L | Standard Deviation 14.011 |
| PF-04950615 0.50 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 34.65 nmol/L | Standard Deviation 14.144 |
| PF-04950615 0.50 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 42.09 nmol/L | Standard Deviation 12.78 |
| PF-04950615 0.50 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 46.30 nmol/L | Standard Deviation 90.153 |
| PF-04950615 1.0 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 23.23 nmol/L | Standard Deviation 10.315 |
| PF-04950615 1.0 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 28.56 nmol/L | Standard Deviation 16.992 |
| PF-04950615 1.0 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 26.65 nmol/L | Standard Deviation 12.759 |
| PF-04950615 1.0 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 39.72 nmol/L | Standard Deviation 18.003 |
| PF-04950615 1.0 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 35.91 nmol/L | Standard Deviation 16.296 |
| PF-04950615 1.0 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 36.69 nmol/L | Standard Deviation 18.98 |
| PF-04950615 1.0 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 25.43 nmol/L | Standard Deviation 14.978 |
| PF-04950615 1.50 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 20.94 nmol/L | Standard Deviation 14.117 |
| PF-04950615 1.50 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 27.71 nmol/L | Standard Deviation 17.448 |
| PF-04950615 1.50 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 18.81 nmol/L | Standard Deviation 12.118 |
| PF-04950615 1.50 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 24.69 nmol/L | Standard Deviation 14.503 |
| PF-04950615 1.50 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 23.56 nmol/L | Standard Deviation 12.336 |
| PF-04950615 1.50 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 28.94 nmol/L | Standard Deviation 18.74 |
| PF-04950615 1.50 mg/kg | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 21.39 nmol/L | Standard Deviation 12.817 |
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615
Tmax is the time at which maximum plasma concentration (Cmax) occurred.
Time frame: Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | Day 1 | 6.00 hour |
| Placebo | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | Day 22 | 6.00 hour |
| PF-04950615 0.25 mg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | Day 22 | 1.30 hour |
| PF-04950615 0.25 mg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | Day 1 | 3.61 hour |
| PF-04950615 0.50 mg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | Day 1 | 1.00 hour |
| PF-04950615 0.50 mg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | Day 22 | 6.00 hour |
| PF-04950615 1.0 mg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | Day 1 | 1.00 hour |
| PF-04950615 1.0 mg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | Day 22 | 6.00 hour |
Secondary
Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Time frame: Day 8, 15, 22, 36, 50, 64 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 31.07 umol/L | Standard Deviation 5.339 |
| Placebo | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 31.61 umol/L | Standard Deviation 4.44 |
| Placebo | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 34.41 umol/L | Standard Deviation 6.21 |
| Placebo | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 32.20 umol/L | Standard Deviation 5.874 |
| Placebo | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 31.83 umol/L | Standard Deviation 6.791 |
| Placebo | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 33.13 umol/L | Standard Deviation 6.369 |
| Placebo | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 32.88 umol/L | Standard Deviation 4.38 |
| PF-04950615 0.25 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 33.21 umol/L | Standard Deviation 3.305 |
| PF-04950615 0.25 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 35.04 umol/L | Standard Deviation 4.876 |
| PF-04950615 0.25 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 35.03 umol/L | Standard Deviation 5.08 |
| PF-04950615 0.25 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 33.84 umol/L | Standard Deviation 4.326 |
| PF-04950615 0.25 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 31.84 umol/L | Standard Deviation 4.979 |
| PF-04950615 0.25 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 36.13 umol/L | Standard Deviation 4.392 |
| PF-04950615 0.25 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 31.14 umol/L | Standard Deviation 5.035 |
| PF-04950615 0.50 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 35.27 umol/L | Standard Deviation 4.077 |
| PF-04950615 0.50 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 33.72 umol/L | Standard Deviation 5.344 |
| PF-04950615 0.50 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 36.27 umol/L | Standard Deviation 5.541 |
| PF-04950615 0.50 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 36.32 umol/L | Standard Deviation 5.852 |
| PF-04950615 0.50 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 34.22 umol/L | Standard Deviation 4.704 |
| PF-04950615 0.50 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 34.08 umol/L | Standard Deviation 3.93 |
| PF-04950615 0.50 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 32.48 umol/L | Standard Deviation 4.043 |
| PF-04950615 1.0 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 34.02 umol/L | Standard Deviation 6.845 |
| PF-04950615 1.0 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 35.69 umol/L | Standard Deviation 6.808 |
| PF-04950615 1.0 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 34.77 umol/L | Standard Deviation 7.503 |
| PF-04950615 1.0 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 31.51 umol/L | Standard Deviation 6.288 |
| PF-04950615 1.0 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 32.88 umol/L | Standard Deviation 5.865 |
| PF-04950615 1.0 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 32.85 umol/L | Standard Deviation 7.554 |
| PF-04950615 1.0 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 35.28 umol/L | Standard Deviation 7.642 |
| PF-04950615 1.50 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 36.97 umol/L | Standard Deviation 5.193 |
| PF-04950615 1.50 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 35.01 umol/L | Standard Deviation 2.773 |
| PF-04950615 1.50 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 37.59 umol/L | Standard Deviation 4.62 |
| PF-04950615 1.50 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 39.16 umol/L | Standard Deviation 5.797 |
| PF-04950615 1.50 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 36.09 umol/L | Standard Deviation 7.021 |
| PF-04950615 1.50 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 34.83 umol/L | Standard Deviation 5.854 |
| PF-04950615 1.50 mg/kg | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 37.59 umol/L | Standard Deviation 4.453 |
Secondary
Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Time frame: Day 8, 15, 22, 36, 50, 64 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 96.56 nmol/L | Standard Deviation 37.874 |
| Placebo | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 91.11 nmol/L | Standard Deviation 38.064 |
| Placebo | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 106.51 nmol/L | Standard Deviation 66.108 |
| Placebo | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 96.27 nmol/L | Standard Deviation 42.925 |
| Placebo | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 102.08 nmol/L | Standard Deviation 40.769 |
| Placebo | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 116.48 nmol/L | Standard Deviation 59.693 |
| Placebo | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 96.89 nmol/L | Standard Deviation 39.372 |
| PF-04950615 0.25 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 100.00 nmol/L | Standard Deviation 44.554 |
| PF-04950615 0.25 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 86.36 nmol/L | Standard Deviation 40.242 |
| PF-04950615 0.25 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 64.16 nmol/L | Standard Deviation 24.573 |
| PF-04950615 0.25 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 74.79 nmol/L | Standard Deviation 27.473 |
| PF-04950615 0.25 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 95.55 nmol/L | Standard Deviation 40.252 |
| PF-04950615 0.25 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 64.85 nmol/L | Standard Deviation 23.841 |
| PF-04950615 0.25 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 86.06 nmol/L | Standard Deviation 31.763 |
| PF-04950615 0.50 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 45.72 nmol/L | Standard Deviation 20.487 |
| PF-04950615 0.50 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 61.11 nmol/L | Standard Deviation 26.738 |
| PF-04950615 0.50 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 63.68 nmol/L | Standard Deviation 44.34 |
| PF-04950615 0.50 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 58.53 nmol/L | Standard Deviation 26.727 |
| PF-04950615 0.50 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 62.46 nmol/L | Standard Deviation 29.705 |
| PF-04950615 0.50 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 65.25 nmol/L | Standard Deviation 27.024 |
| PF-04950615 0.50 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 79.37 nmol/L | Standard Deviation 39.806 |
| PF-04950615 1.0 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 65.47 nmol/L | Standard Deviation 29.936 |
| PF-04950615 1.0 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 68.13 nmol/L | Standard Deviation 29.699 |
| PF-04950615 1.0 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 67.07 nmol/L | Standard Deviation 36.861 |
| PF-04950615 1.0 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 84.64 nmol/L | Standard Deviation 50.216 |
| PF-04950615 1.0 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 80.51 nmol/L | Standard Deviation 45.939 |
| PF-04950615 1.0 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 73.92 nmol/L | Standard Deviation 40.221 |
| PF-04950615 1.0 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 58.99 nmol/L | Standard Deviation 29.746 |
| PF-04950615 1.50 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 55.53 nmol/L | Standard Deviation 23.928 |
| PF-04950615 1.50 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 61.16 nmol/L | Standard Deviation 42.496 |
| PF-04950615 1.50 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 45.81 nmol/L | Standard Deviation 24.781 |
| PF-04950615 1.50 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 53.04 nmol/L | Standard Deviation 31.259 |
| PF-04950615 1.50 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 60.66 nmol/L | Standard Deviation 33.367 |
| PF-04950615 1.50 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 68.14 nmol/L | Standard Deviation 37.104 |
| PF-04950615 1.50 mg/kg | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 51.76 nmol/L | Standard Deviation 26.621 |
Secondary
Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Time frame: Day 8, 15, 22, 36, 50, 64 and 78
Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 48.57 nm | Standard Deviation 6.907 |
| Placebo | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 51.42 nm | Standard Deviation 7.249 |
| Placebo | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 52.42 nm | Standard Deviation 6.876 |
| Placebo | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 52.17 nm | Standard Deviation 11.873 |
| Placebo | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 50.51 nm | Standard Deviation 9.062 |
| Placebo | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 51.57 nm | Standard Deviation 9.261 |
| Placebo | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 48.13 nm | Standard Deviation 4.918 |
| PF-04950615 0.25 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 47.62 nm | Standard Deviation 4.463 |
| PF-04950615 0.25 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 51.21 nm | Standard Deviation 5.29 |
| PF-04950615 0.25 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 52.85 nm | Standard Deviation 5.284 |
| PF-04950615 0.25 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 54.09 nm | Standard Deviation 6.152 |
| PF-04950615 0.25 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 51.81 nm | Standard Deviation 6.03 |
| PF-04950615 0.25 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 46.58 nm | Standard Deviation 6.099 |
| PF-04950615 0.25 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 48.95 nm | Standard Deviation 4.82 |
| PF-04950615 0.50 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 48.60 nm | Standard Deviation 7.661 |
| PF-04950615 0.50 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 53.62 nm | Standard Deviation 15.032 |
| PF-04950615 0.50 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 53.57 nm | Standard Deviation 10.417 |
| PF-04950615 0.50 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 49.41 nm | Standard Deviation 7.249 |
| PF-04950615 0.50 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 53.69 nm | Standard Deviation 10.745 |
| PF-04950615 0.50 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 54.28 nm | Standard Deviation 9.695 |
| PF-04950615 0.50 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 50.15 nm | Standard Deviation 8.341 |
| PF-04950615 1.0 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 50.22 nm | Standard Deviation 4.799 |
| PF-04950615 1.0 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 55.33 nm | Standard Deviation 9.556 |
| PF-04950615 1.0 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 52.48 nm | Standard Deviation 9.738 |
| PF-04950615 1.0 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 51.37 nm | Standard Deviation 6.934 |
| PF-04950615 1.0 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 50.99 nm | Standard Deviation 8.967 |
| PF-04950615 1.0 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 52.95 nm | Standard Deviation 8.965 |
| PF-04950615 1.0 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 53.47 nm | Standard Deviation 8.371 |
| PF-04950615 1.50 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 78 | 49.63 nm | Standard Deviation 6.762 |
| PF-04950615 1.50 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 64 | 51.74 nm | Standard Deviation 5.163 |
| PF-04950615 1.50 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 36 | 52.40 nm | Standard Deviation 9.08 |
| PF-04950615 1.50 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 50 | 54.14 nm | Standard Deviation 10.801 |
| PF-04950615 1.50 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 15 | 50.54 nm | Standard Deviation 5.837 |
| PF-04950615 1.50 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 22 | 53.95 nm | Standard Deviation 8.878 |
| PF-04950615 1.50 mg/kg | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | Day 8 | 50.07 nm | Standard Deviation 6.934 |
Secondary
Volume of Distribution at Steady State (Vss) of PF-04950615
Vss was calculated as CL\*MRT. CL was calculated as Dose/AUCtau, where AUCtau was area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau=168 hours. MRT was mean residence time (predicted) extrapolated to infinity.
Time frame: Day 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Volume of Distribution at Steady State (Vss) of PF-04950615 | 3815 milliliter (mL) | Geometric Coefficient of Variation 111 |
| PF-04950615 0.25 mg/kg | Volume of Distribution at Steady State (Vss) of PF-04950615 | 3221 milliliter (mL) | Geometric Coefficient of Variation 20 |
| PF-04950615 0.50 mg/kg | Volume of Distribution at Steady State (Vss) of PF-04950615 | 4035 milliliter (mL) | Geometric Coefficient of Variation 19 |
| PF-04950615 1.0 mg/kg | Volume of Distribution at Steady State (Vss) of PF-04950615 | 5285 milliliter (mL) | Geometric Coefficient of Variation 25 |