| 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. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Baseline up to Follow-up period (Day 78) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. | | OG004 | 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. |
| | Units | Counts |
|---|
| Participants | - OG00012
- OG00114
- OG00214
- OG003
|
| | Title | Denominators | Categories |
|---|
| With dose limiting treatment related AEs | | |
| |
| 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. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Baseline up to Follow-up period (Day 78) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 |
|
| 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. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Baseline up to Follow-up period (Day 78) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | PF-04950615 0.50 mg/kg | |
|
| 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. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Baseline up to Follow-up period (Day 78) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | PF-04950615 0.25 mg/kg | |
|
| 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. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Baseline up to Follow-up period (Day 78) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Baseline up to Follow-up period (Day 78) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg |
|
| 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. | 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. | Posted | | Number | | participants | | Baseline up to Follow-up period (Day 78) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 |
|
| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/ milliliter (ng*h/mL) | | Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | Tmax is the time at which maximum plasma concentration (Cmax) occurred. | 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. | Posted | | Median | Full Range | hour | | Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.50 mg/kg |
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | | Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.50 mg/kg | |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | hour | | Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter per hour (mL/hr) | | Day 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter (mL) | | Day 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Day 22: pre-dose and 1, 6, 9, 24 and 72 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| Secondary | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | | 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. | Posted | | Mean | Standard Deviation | milligram per deciliter (mg/dL) | | Baseline, Day 8, 15, 22, 29 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78 | | 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. | Posted | | Mean | Standard Deviation | percent change | | Day 8, 15, 22, 29 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL) | | 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. | Posted | | Count of Participants | | Participants | | Day 15, 22, 29 and 36 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
|
| Secondary | Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL) | | 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. | Posted | | Count of Participants | | Participants | | Day 15, 22, 29 and 36 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
|
| Secondary | Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in LDL-C From Baseline | | 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. | Posted | | Count of Participants | | Participants | | Baseline, Day 15, 22, 29 and 36 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
|
| Secondary | Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | | 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. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Day 8, 15, 22, 29 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
|
| Secondary | Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | | 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. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Day 8, 15, 22, 29 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
|
| Secondary | Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | | 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. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Day 8, 15, 22, 29 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
|
| Secondary | Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | | 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. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Day 8, 15, 22, 29 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | | 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. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Day 8, 15, 22, 29 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | | 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. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Day 8, 15, 22, 29 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
|
| Secondary | Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78 | | 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. | Posted | | Mean | Standard Deviation | percent change | | Day 8, 15, 22, 29 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78 | | 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. | Posted | | Mean | Standard Deviation | percent change | | Day 8, 15, 22, 29 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78 | | 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. | Posted | | Mean | Standard Deviation | percent change | | Day 8, 15, 22, 29 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
|
| Secondary | Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78 | | Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. | Posted | | Mean | Standard Deviation | percent change | | Day 8, 15, 22, 29 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
|
| Secondary | Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78 | | 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. | Posted | | Mean | Standard Deviation | percent change | | Day 8, 15, 22, 29 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78 | | 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. | Posted | | Mean | Standard Deviation | percent change | | Day 8, 15, 22, 29 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
|
| Secondary | Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | | 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. | Posted | | Mean | Standard Deviation | nanometer (nm) | | Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | | 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. | Posted | | Mean | Standard Deviation | nanomoles per liter (nmol/L) | | Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | | 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. | Posted | | Mean | Standard Deviation | nmol/L | | Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | | 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. | Posted | | Mean | Standard Deviation | nmol/L | | Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | | 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. | Posted | | Mean | Standard Deviation | nmol/L | | Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | | Pharmacodynamic analysis population was defined as all enrolled participants who received at least 1 dose of study medication and had atleast 1 pharmacodynamic parameter. | Posted | | Mean | Standard Deviation | ng/mL | | Baseline, Day 8, 15, 22, 36, 50, 64 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
|
| Secondary | C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78 | | 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. | Posted | | Mean | Standard Deviation | mg/dL | | Day 8, 15, 21, 36, 57 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
|
| Secondary | Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | | 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. | Posted | | Mean | Standard Deviation | micromole/liter (umol/L) | | Day 8, 15, 22, 36, 50, 64 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | | 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. | Posted | | Mean | Standard Deviation | umol/L | | Day 8, 15, 22, 36, 50, 64 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | | 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. | Posted | | Mean | Standard Deviation | umol/L | | Day 8, 15, 22, 36, 50, 64 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | | 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. | Posted | | Mean | Standard Deviation | umol/L | | Day 8, 15, 22, 36, 50, 64 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | | 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. | Posted | | Mean | Standard Deviation | nmol/L | | Day 8, 15, 22, 36, 50, 64 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | | 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. | Posted | | Mean | Standard Deviation | nmol/L | | Day 8, 15, 22, 36, 50, 64 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | | 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. | Posted | | Mean | Standard Deviation | nmol/L | | Day 8, 15, 22, 36, 50, 64 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78 | | 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. | Posted | | Mean | Standard Deviation | nmol/L | | Day 8, 15, 22, 36, 50, 64 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-04950615 1.0 mg/kg | |
|
| Secondary | High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | | 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. | Posted | | Mean | Standard Deviation | nm | | Day 8, 15, 22, 36, 50, 64 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
|
| Secondary | Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78 | | 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. | Posted | | Mean | Standard Deviation | nm | | Day 8, 15, 22, 36, 50, 64 and 78 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
|