Dyslipidemia, Hypercholesterolemia
Conditions
Keywords
PF-04950615, RN316
Brief summary
This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.
Interventions
BIOLOGICALPlacebo
Intravenous placebo monthly during treatment phase.
DRUGStatin
Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
BIOLOGICALPF-04950615 (RN316)
Intravenous 10mg/mL based on weight monthly during treatment phase.
DRUGSatin
Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* On a stable daily dose of atorvastatin, rosuvastatin or simvastatin. * Lipids meet the following criteria at screening and prior to dosing: Fasting LDL-C greater than 100 mg/dL and fasting TG less than 400 mg/dL
Exclusion criteria
* History of a cardiovascular or cerebrovascular event or procedure during the past year. * Poorly controlled type 1 or type 2 diabetes mellitus. * Poorly controlled hypertension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 | Baseline, Day 85 | Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 29, 57, 85 | — |
| Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 29, 57, 85 | — |
| Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline, Day 29, 57, 85 | Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. |
| Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline, Day 29, 57, 85 | Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 1 up to Day 141 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, SAEs and treatment-related TEAEs were reported. |
| Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Day 1 up to Day 141 | Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (\>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of \>=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of \>=25 percent (%) for baseline value of \>200 millisecond (msec) and maximum increase of \>=50% for baseline value of less than or equal to (\<=) 200 msec for PR and QRS interval; maximum increase from baseline of \>30 to \<=60 msec and maximum increase from baseline of \>60 msec for QT interval corrected using the Fridericia's formula (QTCF). |
| Number of Participants With Anti-drug Antibody (ADA) | Day 1 up to Day 141 | Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value \>=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure. |
| Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Day 1 up to Day 141 | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Investigator assessed TEAEs as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) or severe (interfered significantly with participant's usual function). TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. |
| Number of Participants With Clinically Relevant Laboratory Abnormalities | Day 1 up to Day 141 | Hematology (hemoglobin\[hgb\],hematocrit,red blood cell\[RBC\]\<0.8\*lower limit of normal\[LLN\],mean cell\[MC\] volume,MC hgb,MC hg concentration \<0.9\*LLN, greater than\[\>\] 1.1\*upper limit of normal\[ULN\], platelet \<0.5\*LLN,\>1.75\*ULN, white blood cell\[WBC\]\<0.6\*LLN,\>1.5\*ULN,neutrophil,lymphocyte \<0.8\*LLN,\>1.2\*ULN,eosinophil,basophil,monocyte \>1.2\*ULN);chemistry(total, direct, indirect bilirubin\[BR\]\>1.5\*ULN,aspartate aminotransferase\[AT\],alanine AT,alkaline phosphatase,gamma-glutyl transferase\>3.0\*ULN,protein,lactate dehydrogenase \<0.8\*LLN,\>1.2\*ULN,creatinine,blood urea nitrogen\>1.3\*ULN,uric acid \>1.2\*ULN,potassium,chloride,calcium,bicarbonate\<0.9\*LLN,\>1.1\*ULN, sodium\<0.95\*LLN,\>1.05\*ULN,glucose\[GL\]\<0.6\*LLN,\>1.5\*ULN,amylase,lipase \>1.5\*ULN,creatinine kinase\>2.0\*ULN);urinalysis(pH \<4.5,\>8,specific gravity\<1.003 , \>1.030, GL,ketone,protein,hgb,BR,nitrite,leukocyte greater than or equal to \[\>=\]1, RBC, WBC \>=20);coagulation(prothrombin\[PT\],PT international ratio,partial thromboplastin time\>1.1\*ULN). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Baseline, Day 29, 57, 71, 85, 99, 127, 141 | Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. |
| Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Baseline, Day 29, 57, 71, 85, 99, 127, 141 | Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram \[mg\]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. | 19 |
| PF-04950615 0.25 mg/kg Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. | 17 |
| PF-04950615 1.0 mg/kg Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. | 18 |
| PF-04950615 3.0 mg/kg Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. | 19 |
| PF-04950615 6.0 mg/kg Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. | 17 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Randomized, but not Treated | 0 | 2 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | PF-04950615 0.25 mg/kg | PF-04950615 1.0 mg/kg | PF-04950615 3.0 mg/kg | PF-04950615 6.0 mg/kg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 12.4 | 57.9 years STANDARD_DEVIATION 10.3 | 56.3 years STANDARD_DEVIATION 9.1 | 58.0 years STANDARD_DEVIATION 10.6 | 60.8 years STANDARD_DEVIATION 5.7 | 58.4 years STANDARD_DEVIATION 9.9 |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 11 Participants | 11 Participants | 8 Participants | 45 Participants |
| Sex: Female, Male Male | 13 Participants | 8 Participants | 7 Participants | 8 Participants | 9 Participants | 45 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 | 14 / 19 | 13 / 17 | 13 / 18 | 11 / 19 | 11 / 17 |
| serious Total, serious adverse events | 0 / 19 | 1 / 17 | 1 / 18 | 0 / 19 | 0 / 17 |
Outcome results
Primary
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Time frame: Baseline, Day 85
Population: Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. Here 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 | -8.91 percent change | Standard Deviation 20.075 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 | -13.11 percent change | Standard Deviation 20.786 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 | -8.63 percent change | Standard Deviation 30.394 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 | -47.20 percent change | Standard Deviation 31.021 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 | -56.48 percent change | Standard Deviation 35.289 |
Comparison: Analysis was performed using analysis of covariance (ANCOVA) model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.p-value: 0.566195% CI: [-25.09, 13.83]ANCOVA
Comparison: Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.p-value: 0.80895% CI: [-21.08, 16.49]ANCOVA
Comparison: Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.p-value: 0.000195% CI: [-56.47, -18.97]ANCOVA
Comparison: Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.p-value: <0.000195% CI: [-68.08, -30.14]ANCOVA
Secondary
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Time frame: Baseline, Day 29, 57, 85
Population: Efficacy analysis set. 'number analyzed' = participants who were evaluable at specified time points for each arm. Results for change at Day 85 in lipid parameters ApoB and ApoA1 were not reported because data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: ApoA1 | 1.68 milligram per deciliter (mg/dL) | Standard Deviation 10.546 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: TG | 8.66 milligram per deciliter (mg/dL) | Standard Deviation 46.865 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: Non-HDL-C | -11.06 milligram per deciliter (mg/dL) | Standard Deviation 26.14 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: HDL-C | -0.74 milligram per deciliter (mg/dL) | Standard Deviation 5.31 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: ApoB | -5.05 milligram per deciliter (mg/dL) | Standard Deviation 16.119 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: Non-HDL-C | 156.63 milligram per deciliter (mg/dL) | Standard Deviation 30.61 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: TC | -13.97 milligram per deciliter (mg/dL) | Standard Deviation 28.37 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: TC | -10.97 milligram per deciliter (mg/dL) | Standard Deviation 24.41 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: TG | 136.18 milligram per deciliter (mg/dL) | Standard Deviation 58.82 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: TG | 2.97 milligram per deciliter (mg/dL) | Standard Deviation 59.087 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: HDL-C | 0.08 milligram per deciliter (mg/dL) | Standard Deviation 5.219 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: ApoB | 106.74 milligram per deciliter (mg/dL) | Standard Deviation 19.86 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: TC | 202.82 milligram per deciliter (mg/dL) | Standard Deviation 27.96 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: ApoA1 | -2.59 milligram per deciliter (mg/dL) | Standard Deviation 15.5 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: ApoA1 | 140.32 milligram per deciliter (mg/dL) | Standard Deviation 21.71 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: ApoB | -8.94 milligram per deciliter (mg/dL) | Standard Deviation 14.355 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: HDL-C | 0.87 milligram per deciliter (mg/dL) | Standard Deviation 5.627 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: TG | -1.24 milligram per deciliter (mg/dL) | Standard Deviation 61.405 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29:TC | -10.66 milligram per deciliter (mg/dL) | Standard Deviation 31.13 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: Non-HDL-C | -13.24 milligram per deciliter (mg/dL) | Standard Deviation 29.52 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: Non-HDL-C | -11.53 milligram per deciliter (mg/dL) | Standard Deviation 33.16 |
| Placebo | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: HDL-C | 46.18 milligram per deciliter (mg/dL) | Standard Deviation 10.235 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: Non-HDL-C | -13.56 milligram per deciliter (mg/dL) | Standard Deviation 28.17 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: ApoA1 | -0.13 milligram per deciliter (mg/dL) | Standard Deviation 14.02 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: TG | -3.72 milligram per deciliter (mg/dL) | Standard Deviation 31.384 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: TC | -5.67 milligram per deciliter (mg/dL) | Standard Deviation 18.777 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: HDL-C | 2.23 milligram per deciliter (mg/dL) | Standard Deviation 8.113 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29:TC | -9.97 milligram per deciliter (mg/dL) | Standard Deviation 29.104 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: ApoA1 | 153.76 milligram per deciliter (mg/dL) | Standard Deviation 22.73 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: ApoB | -9.56 milligram per deciliter (mg/dL) | Standard Deviation 18.155 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: TC | 202.03 milligram per deciliter (mg/dL) | Standard Deviation 27.1 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: ApoA1 | 2.06 milligram per deciliter (mg/dL) | Standard Deviation 17.117 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: ApoB | -1.07 milligram per deciliter (mg/dL) | Standard Deviation 12.384 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: Non-HDL-C | 150.50 milligram per deciliter (mg/dL) | Standard Deviation 29.03 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: TG | -25.97 milligram per deciliter (mg/dL) | Standard Deviation 49.96 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: TC | -20.56 milligram per deciliter (mg/dL) | Standard Deviation 31.99 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: Non-HDL-C | -22.38 milligram per deciliter (mg/dL) | Standard Deviation 34.45 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: Non-HDL-C | -7.90 milligram per deciliter (mg/dL) | Standard Deviation 21.123 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: TG | 137.62 milligram per deciliter (mg/dL) | Standard Deviation 87.56 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: HDL-C | 3.59 milligram per deciliter (mg/dL) | Standard Deviation 7.265 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: HDL-C | 1.81 milligram per deciliter (mg/dL) | Standard Deviation 9.377 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: HDL-C | 51.53 milligram per deciliter (mg/dL) | Standard Deviation 14.084 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: TG | -11.37 milligram per deciliter (mg/dL) | Standard Deviation 36.99 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: ApoB | 105.76 milligram per deciliter (mg/dL) | Standard Deviation 18.21 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: Non-HDL-C | -22.74 milligram per deciliter (mg/dL) | Standard Deviation 14.91 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: HDL-C | 49.11 milligram per deciliter (mg/dL) | Standard Deviation 13.291 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: TC | 205.11 milligram per deciliter (mg/dL) | Standard Deviation 22.64 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: Non-HDL-C | 156.00 milligram per deciliter (mg/dL) | Standard Deviation 24.08 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: TG | 162.83 milligram per deciliter (mg/dL) | Standard Deviation 85.68 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: ApoB | 109.83 milligram per deciliter (mg/dL) | Standard Deviation 23.61 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: ApoA1 | 146.44 milligram per deciliter (mg/dL) | Standard Deviation 20.35 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: HDL-C | 0.79 milligram per deciliter (mg/dL) | Standard Deviation 5.041 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29:TC | -21.94 milligram per deciliter (mg/dL) | Standard Deviation 15.93 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: TG | -37.03 milligram per deciliter (mg/dL) | Standard Deviation 66.12 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: ApoB | -13.24 milligram per deciliter (mg/dL) | Standard Deviation 15.63 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: ApoA1 | 4.29 milligram per deciliter (mg/dL) | Standard Deviation 11.751 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: HDL-C | 2.83 milligram per deciliter (mg/dL) | Standard Deviation 8.004 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: TC | -8.20 milligram per deciliter (mg/dL) | Standard Deviation 39.052 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: Non-HDL-C | -11.03 milligram per deciliter (mg/dL) | Standard Deviation 39.49 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: TG | -15.73 milligram per deciliter (mg/dL) | Standard Deviation 95.34 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: ApoB | -3.87 milligram per deciliter (mg/dL) | Standard Deviation 27.302 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: ApoA1 | 8.47 milligram per deciliter (mg/dL) | Standard Deviation 18.917 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: HDL-C | 1.44 milligram per deciliter (mg/dL) | Standard Deviation 5.739 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: TC | -11.56 milligram per deciliter (mg/dL) | Standard Deviation 43.45 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: Non-HDL-C | -13.00 milligram per deciliter (mg/dL) | Standard Deviation 40.28 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: TG | -9.39 milligram per deciliter (mg/dL) | Standard Deviation 63.159 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: HDL-C | 4.50 milligram per deciliter (mg/dL) | Standard Deviation 4.624 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: TC | 202.66 milligram per deciliter (mg/dL) | Standard Deviation 37.98 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: TC | -51.33 milligram per deciliter (mg/dL) | Standard Deviation 52.08 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29:TC | -81.00 milligram per deciliter (mg/dL) | Standard Deviation 49.61 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: TG | -6.58 milligram per deciliter (mg/dL) | Standard Deviation 58.104 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: Non-HDL-C | -54.50 milligram per deciliter (mg/dL) | Standard Deviation 55.71 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: Non-HDL-C | -85.50 milligram per deciliter (mg/dL) | Standard Deviation 48.59 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: Non-HDL-C | -68.39 milligram per deciliter (mg/dL) | Standard Deviation 54.01 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: TG | -4.47 milligram per deciliter (mg/dL) | Standard Deviation 74.402 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: ApoA1 | 143.11 milligram per deciliter (mg/dL) | Standard Deviation 20.31 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: ApoB | -29.07 milligram per deciliter (mg/dL) | Standard Deviation 31.83 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: ApoB | 102.84 milligram per deciliter (mg/dL) | Standard Deviation 22.06 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: ApoA1 | 8.39 milligram per deciliter (mg/dL) | Standard Deviation 20.448 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: TG | 118.05 milligram per deciliter (mg/dL) | Standard Deviation 47.08 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: HDL-C | 50.24 milligram per deciliter (mg/dL) | Standard Deviation 11.724 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: HDL-C | 5.50 milligram per deciliter (mg/dL) | Standard Deviation 7.31 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: Non-HDL-C | 152.42 milligram per deciliter (mg/dL) | Standard Deviation 38.89 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: TC | -62.89 milligram per deciliter (mg/dL) | Standard Deviation 52.73 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: ApoB | -47.13 milligram per deciliter (mg/dL) | Standard Deviation 23.85 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: ApoA1 | 11.67 milligram per deciliter (mg/dL) | Standard Deviation 14.892 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: TG | -18.97 milligram per deciliter (mg/dL) | Standard Deviation 48.88 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: HDL-C | 3.17 milligram per deciliter (mg/dL) | Standard Deviation 7.462 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: TC | 206.91 milligram per deciliter (mg/dL) | Standard Deviation 35.96 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: ApoA1 | 10.12 milligram per deciliter (mg/dL) | Standard Deviation 14.168 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: TG | 172.47 milligram per deciliter (mg/dL) | Standard Deviation 86.49 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: TC | -79.21 milligram per deciliter (mg/dL) | Standard Deviation 52.81 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29:TC | -111.68 milligram per deciliter (mg/dL) | Standard Deviation 28.7 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: TC | -79.97 milligram per deciliter (mg/dL) | Standard Deviation 55.39 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: Non-HDL-C | -117.68 milligram per deciliter (mg/dL) | Standard Deviation 25.9 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: ApoA1 | 7.29 milligram per deciliter (mg/dL) | Standard Deviation 12.875 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: Non-HDL-C | -84.09 milligram per deciliter (mg/dL) | Standard Deviation 54.92 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: HDL-C | 6.00 milligram per deciliter (mg/dL) | Standard Deviation 6.072 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: HDL-C | 4.82 milligram per deciliter (mg/dL) | Standard Deviation 7.671 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: Non-HDL-C | 162.15 milligram per deciliter (mg/dL) | Standard Deviation 37.82 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: TG | -46.94 milligram per deciliter (mg/dL) | Standard Deviation 65.2 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: TG | -26.71 milligram per deciliter (mg/dL) | Standard Deviation 49.54 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: ApoA1 | 141.29 milligram per deciliter (mg/dL) | Standard Deviation 16.25 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: TG | -40.12 milligram per deciliter (mg/dL) | Standard Deviation 73.83 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 85: Non-HDL-C | -84.79 milligram per deciliter (mg/dL) | Standard Deviation 52.95 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: HDL-C | 4.88 milligram per deciliter (mg/dL) | Standard Deviation 7.167 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 57: ApoB | -45.90 milligram per deciliter (mg/dL) | Standard Deviation 36.6 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: ApoB | 109.06 milligram per deciliter (mg/dL) | Standard Deviation 29.49 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Change at Day 29: ApoB | -67.40 milligram per deciliter (mg/dL) | Standard Deviation 22.03 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Baseline: HDL-C | 44.76 milligram per deciliter (mg/dL) | Standard Deviation 8.189 |
Secondary
Number of Participants With Anti-drug Antibody (ADA)
Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value \>=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.
Time frame: Day 1 up to Day 141
Population: Analysis set included all participants who received at least 1 dose of PF-04950615 (RN316).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Anti-drug Antibody (ADA) | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Anti-drug Antibody (ADA) | 3 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Anti-drug Antibody (ADA) | 1 participants |
| PF-04950615 3.0 mg/kg | Number of Participants With Anti-drug Antibody (ADA) | 1 participants |
Secondary
Number of Participants With Clinically Relevant Laboratory Abnormalities
Hematology (hemoglobin\[hgb\],hematocrit,red blood cell\[RBC\]\<0.8\*lower limit of normal\[LLN\],mean cell\[MC\] volume,MC hgb,MC hg concentration \<0.9\*LLN, greater than\[\>\] 1.1\*upper limit of normal\[ULN\], platelet \<0.5\*LLN,\>1.75\*ULN, white blood cell\[WBC\]\<0.6\*LLN,\>1.5\*ULN,neutrophil,lymphocyte \<0.8\*LLN,\>1.2\*ULN,eosinophil,basophil,monocyte \>1.2\*ULN);chemistry(total, direct, indirect bilirubin\[BR\]\>1.5\*ULN,aspartate aminotransferase\[AT\],alanine AT,alkaline phosphatase,gamma-glutyl transferase\>3.0\*ULN,protein,lactate dehydrogenase \<0.8\*LLN,\>1.2\*ULN,creatinine,blood urea nitrogen\>1.3\*ULN,uric acid \>1.2\*ULN,potassium,chloride,calcium,bicarbonate\<0.9\*LLN,\>1.1\*ULN, sodium\<0.95\*LLN,\>1.05\*ULN,glucose\[GL\]\<0.6\*LLN,\>1.5\*ULN,amylase,lipase \>1.5\*ULN,creatinine kinase\>2.0\*ULN);urinalysis(pH \<4.5,\>8,specific gravity\<1.003 , \>1.030, GL,ketone,protein,hgb,BR,nitrite,leukocyte greater than or equal to \[\>=\]1, RBC, WBC \>=20);coagulation(prothrombin\[PT\],PT international ratio,partial thromboplastin time\>1.1\*ULN).
Time frame: Day 1 up to Day 141
Population: Safety analysis set included all participants who received at least 1 dose of study drug. Here 'N' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Clinically Relevant Laboratory Abnormalities | 18 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Relevant Laboratory Abnormalities | 15 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Relevant Laboratory Abnormalities | 17 participants |
| PF-04950615 3.0 mg/kg | Number of Participants With Clinically Relevant Laboratory Abnormalities | 18 participants |
| PF-04950615 6.0 mg/kg | Number of Participants With Clinically Relevant Laboratory Abnormalities | 14 participants |
Secondary
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (\>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of \>=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of \>=25 percent (%) for baseline value of \>200 millisecond (msec) and maximum increase of \>=50% for baseline value of less than or equal to (\<=) 200 msec for PR and QRS interval; maximum increase from baseline of \>30 to \<=60 msec and maximum increase from baseline of \>60 msec for QT interval corrected using the Fridericia's formula (QTCF).
Time frame: Day 1 up to Day 141
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 Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine systolic BP: Maximum increase >=30mmHg | 2 participants |
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine diastolic BP: Maximum increase >=20mmHg | 2 participants |
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine systolic BP: Maximum decrease >=30mmHg | 1 participants |
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine diastolic BP: Maximum decrease >=20mmHg | 1 participants |
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | PR interval: >=25/50% increase | 0 participants |
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QRS interval: >=25/50% increase | 0 participants |
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QTCF: Maximum increase >30 to <=60 msec | 1 participants |
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QTCF: Maximum increase >60 msec | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine systolic BP: Maximum decrease >=30mmHg | 3 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QRS interval: >=25/50% increase | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine systolic BP: Maximum increase >=30mmHg | 4 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine diastolic BP: Maximum decrease >=20mmHg | 4 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine diastolic BP: Maximum increase >=20mmHg | 2 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QTCF: Maximum increase >60 msec | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | PR interval: >=25/50% increase | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QTCF: Maximum increase >30 to <=60 msec | 3 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QTCF: Maximum increase >30 to <=60 msec | 3 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QTCF: Maximum increase >60 msec | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine diastolic BP: Maximum decrease >=20mmHg | 1 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QRS interval: >=25/50% increase | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine systolic BP: Maximum decrease >=30mmHg | 0 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine diastolic BP: Maximum increase >=20mmHg | 2 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine systolic BP: Maximum increase >=30mmHg | 3 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | PR interval: >=25/50% increase | 0 participants |
| PF-04950615 3.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine diastolic BP: Maximum increase >=20mmHg | 2 participants |
| PF-04950615 3.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine systolic BP: Maximum decrease >=30mmHg | 2 participants |
| PF-04950615 3.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine diastolic BP: Maximum decrease >=20mmHg | 4 participants |
| PF-04950615 3.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | PR interval: >=25/50% increase | 0 participants |
| PF-04950615 3.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QRS interval: >=25/50% increase | 0 participants |
| PF-04950615 3.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QTCF: Maximum increase >60 msec | 0 participants |
| PF-04950615 3.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine systolic BP: Maximum increase >=30mmHg | 3 participants |
| PF-04950615 3.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QTCF: Maximum increase >30 to <=60 msec | 1 participants |
| PF-04950615 6.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine diastolic BP: Maximum decrease >=20mmHg | 2 participants |
| PF-04950615 6.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QTCF: Maximum increase >60 msec | 0 participants |
| PF-04950615 6.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine systolic BP: Maximum decrease >=30mmHg | 3 participants |
| PF-04950615 6.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QTCF: Maximum increase >30 to <=60 msec | 2 participants |
| PF-04950615 6.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine systolic BP: Maximum increase >=30mmHg | 0 participants |
| PF-04950615 6.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | QRS interval: >=25/50% increase | 0 participants |
| PF-04950615 6.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Supine diastolic BP: Maximum increase >=20mmHg | 0 participants |
| PF-04950615 6.0 mg/kg | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | PR interval: >=25/50% increase | 0 participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, SAEs and treatment-related TEAEs were reported.
Time frame: Day 1 up to Day 141
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs | 14 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment related TEAEs | 3 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TESAEs | 0 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TESAEs | 1 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs | 13 participants |
| PF-04950615 0.25 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment related TEAEs | 4 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TESAEs | 1 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs | 13 participants |
| PF-04950615 1.0 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment related TEAEs | 2 participants |
| PF-04950615 3.0 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs | 11 participants |
| PF-04950615 3.0 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment related TEAEs | 2 participants |
| PF-04950615 3.0 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TESAEs | 0 participants |
| PF-04950615 6.0 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TESAEs | 0 participants |
| PF-04950615 6.0 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs | 11 participants |
| PF-04950615 6.0 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment related TEAEs | 3 participants |
Secondary
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Investigator assessed TEAEs as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) or severe (interfered significantly with participant's usual function). TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Day 1 up to Day 141
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Mild | 24 adverse events |
| Placebo | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Severe | 0 adverse events |
| Placebo | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Moderate | 2 adverse events |
| PF-04950615 0.25 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Moderate | 16 adverse events |
| PF-04950615 0.25 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Mild | 18 adverse events |
| PF-04950615 0.25 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Severe | 1 adverse events |
| PF-04950615 1.0 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Moderate | 13 adverse events |
| PF-04950615 1.0 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Mild | 30 adverse events |
| PF-04950615 1.0 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Severe | 1 adverse events |
| PF-04950615 3.0 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Mild | 18 adverse events |
| PF-04950615 3.0 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Severe | 0 adverse events |
| PF-04950615 3.0 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Moderate | 12 adverse events |
| PF-04950615 6.0 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Moderate | 10 adverse events |
| PF-04950615 6.0 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Mild | 17 adverse events |
| PF-04950615 6.0 mg/kg | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | Severe | 0 adverse events |
Secondary
Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: Day 29, 57, 85
Population: Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. 'N' = participants who were evaluable for this outcome measure and 'number analyzed' = participants who were evaluable at specified time points for each arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 57 | 11.8 percentage of participants |
| Placebo | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 29 | 15.8 percentage of participants |
| Placebo | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 85 | 16.7 percentage of participants |
| PF-04950615 0.25 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 57 | 0 percentage of participants |
| PF-04950615 0.25 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 29 | 25.0 percentage of participants |
| PF-04950615 0.25 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 85 | 18.8 percentage of participants |
| PF-04950615 1.0 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 57 | 26.7 percentage of participants |
| PF-04950615 1.0 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 29 | 11.8 percentage of participants |
| PF-04950615 1.0 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 85 | 22.2 percentage of participants |
| PF-04950615 3.0 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 29 | 88.9 percentage of participants |
| PF-04950615 3.0 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 85 | 66.7 percentage of participants |
| PF-04950615 3.0 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 57 | 55.6 percentage of participants |
| PF-04950615 6.0 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 57 | 76.5 percentage of participants |
| PF-04950615 6.0 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 29 | 100 percentage of participants |
| PF-04950615 6.0 mg/kg | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Day 85 | 82.4 percentage of participants |
Comparison: Day 29: The standard logistic regression model was used to assess treatment effect.p-value: 0.543695% CI: [0.32, 8.83]Regression, Logistic
Comparison: Day 29: The standard logistic regression model was used to assess treatment effect.p-value: 0.74295% CI: [0.12, 4.63]Regression, Logistic
Comparison: Day 29: The standard logistic regression model was used to assess treatment effect.p-value: 0.000295% CI: [4.73, 167.62]Regression, Logistic
Comparison: Day 29: The standard logistic regression model was used to assess treatment effect.p-value: 0.000195% CI: [7.88, 643.42]Regression, Logistic
Comparison: Day 57: The standard logistic regression model was used to assess treatment effect.p-value: 0.32195% CI: [0.01, 4.74]Regression, Logistic
Comparison: Day 57: The standard logistic regression model was used to assess treatment effect.p-value: 0.378695% CI: [0.39, 12.27]Regression, Logistic
Comparison: Day 57: The standard logistic regression model was used to assess treatment effect.p-value: 0.014495% CI: [1.5, 38.38]Regression, Logistic
Comparison: Day 57: The standard logistic regression model was used to assess treatment effect.p-value: 0.000795% CI: [3.59, 116.6]Regression, Logistic
Comparison: Day 85: The standard logistic regression model was used to assess treatment effect.p-value: 0.862695% CI: [0.21, 6.3]Regression, Logistic
Comparison: Day 85: The standard logistic regression model was used to assess treatment effect.p-value: 0.623795% CI: [0.3, 7.51]Regression, Logistic
Comparison: Day 85: The standard logistic regression model was used to assess treatment effect.p-value: 0.007295% CI: [1.76, 36.65]Regression, Logistic
Comparison: Day 85: The standard logistic regression model was used to assess treatment effect.p-value: 0.000595% CI: [3.73, 113.2]Regression, Logistic
Secondary
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL)
Time frame: Day 29, 57, 85
Population: Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. 'N' = participants who were evaluable for this outcome measure and 'number analyzed' = participants who were evaluable at specified time points for each arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 29 <70 mg/dL | 5.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 29 <100 mg/dL | 47.4 percentage of participants |
| Placebo | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 57 <70 mg/dL | 0 percentage of participants |
| Placebo | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 57 <100 mg/dL | 47.1 percentage of participants |
| Placebo | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 85 <70 mg/dL | 5.6 percentage of participants |
| Placebo | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 85 <100 mg/dL | 33.3 percentage of participants |
| PF-04950615 0.25 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 85 <70 mg/dL | 0 percentage of participants |
| PF-04950615 0.25 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 85 <100 mg/dL | 50.0 percentage of participants |
| PF-04950615 0.25 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 29 <70 mg/dL | 6.3 percentage of participants |
| PF-04950615 0.25 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 57 <70 mg/dL | 0 percentage of participants |
| PF-04950615 0.25 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 57 <100 mg/dL | 13.3 percentage of participants |
| PF-04950615 0.25 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 29 <100 mg/dL | 18.8 percentage of participants |
| PF-04950615 1.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 57 <100 mg/dL | 53.3 percentage of participants |
| PF-04950615 1.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 85 <70 mg/dL | 11.1 percentage of participants |
| PF-04950615 1.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 29 <70 mg/dL | 11.8 percentage of participants |
| PF-04950615 1.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 57 <70 mg/dL | 0 percentage of participants |
| PF-04950615 1.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 29 <100 mg/dL | 35.3 percentage of participants |
| PF-04950615 1.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 85 <100 mg/dL | 33.3 percentage of participants |
| PF-04950615 3.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 57 <100 mg/dL | 66.7 percentage of participants |
| PF-04950615 3.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 29 <100 mg/dL | 94.4 percentage of participants |
| PF-04950615 3.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 57 <70 mg/dL | 44.4 percentage of participants |
| PF-04950615 3.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 85 <100 mg/dL | 88.9 percentage of participants |
| PF-04950615 3.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 85 <70 mg/dL | 66.7 percentage of participants |
| PF-04950615 3.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 29 <70 mg/dL | 77.8 percentage of participants |
| PF-04950615 6.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 85 <70 mg/dL | 64.7 percentage of participants |
| PF-04950615 6.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 57 <70 mg/dL | 76.5 percentage of participants |
| PF-04950615 6.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 29 <100 mg/dL | 100 percentage of participants |
| PF-04950615 6.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 85 <100 mg/dL | 76.5 percentage of participants |
| PF-04950615 6.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 57 <100 mg/dL | 88.2 percentage of participants |
| PF-04950615 6.0 mg/kg | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 29 <70 mg/dL | 100 percentage of participants |
Comparison: Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.899895% CI: [0.1, 13.92]Regression, Logistic
Comparison: Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.527395% CI: [0.22, 19.48]Regression, Logistic
Comparison: Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.000495% CI: [5.93, 490.67]Regression, Logistic
Comparison: Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: <0.000195% CI: [18.65, 4214.35]Regression, Logistic
Comparison: Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.08695% CI: [0.06, 1.21]Regression, Logistic
Comparison: Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.430895% CI: [0.15, 2.25]Regression, Logistic
Comparison: Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.012795% CI: [1.57, 43.56]Regression, Logistic
Comparison: Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.009695% CI: [1.89, 97]Regression, Logistic
Comparison: Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.951995% CI: [0.02, 61.54]Regression, Logistic
Comparison: Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.97495% CI: [0.02, 58]Regression, Logistic
Comparison: Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.027395% CI: [1.46, 549.78]Regression, Logistic
Comparison: Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.002295% CI: [5.5, 2384.03]Regression, Logistic
Comparison: Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.068495% CI: [0.04, 1.12]Regression, Logistic
Comparison: Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.906895% CI: [0.29, 3.99]Regression, Logistic
Comparison: Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.223595% CI: [0.61, 8.31]Regression, Logistic
Comparison: Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.01295% CI: [1.59, 42.82]Regression, Logistic
Comparison: Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.544995% CI: [0.01, 9.92]Regression, Logistic
Comparison: Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.558595% CI: [0.22, 16.85]Regression, Logistic
Comparison: Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.002295% CI: [3, 147.65]Regression, Logistic
Comparison: Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.00295% CI: [3.15, 165.99]Regression, Logistic
Comparison: Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.37595% CI: [0.48, 7.12]Regression, Logistic
Comparison: Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.91495% CI: [0.28, 4.23]Regression, Logistic
Comparison: Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.003695% CI: [2.09, 43.57]Regression, Logistic
Comparison: Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.p-value: 0.014995% CI: [1.42, 26.1]Regression, Logistic
Secondary
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Time frame: Baseline, Day 29, 57, 85
Population: Efficacy analysis set. 'number analyzed' = participants who were evaluable at specified time points for each arm. Results for percent change at Day 85 for ApoB and ApoA1 were not reported because data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: ApoB | -4.09 percent change | Standard Deviation 14.429 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: TC | -5.03 percent change | Standard Deviation 15.148 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29:Non-HDL-C | -7.14 percent change | Standard Deviation 20.758 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: TG | 9.83 percent change | Standard Deviation 35.146 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: HDL-C | 1.98 percent change | Standard Deviation 11.164 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: ApoA1 | 1.24 percent change | Standard Deviation 7.493 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: HDL-C | -1.09 percent change | Standard Deviation 10.708 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: TC | -6.91 percent change | Standard Deviation 13.742 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: Non-HDL-C | -8.34 percent change | Standard Deviation 18.789 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: TG | 5.90 percent change | Standard Deviation 42.384 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: ApoB | -8.32 percent change | Standard Deviation 13.214 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: ApoA1 | -1.70 percent change | Standard Deviation 11.575 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: HDL-C | 0.87 percent change | Standard Deviation 10.121 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: TC | -5.44 percent change | Standard Deviation 12.468 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: Non-HDL-C | -6.78 percent change | Standard Deviation 17.417 |
| Placebo | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: TG | 6.16 percent change | Standard Deviation 42.923 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: TC | -9.45 percent change | Standard Deviation 14.947 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: TG | -2.62 percent change | Standard Deviation 21.43 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: Non-HDL-C | -4.26 percent change | Standard Deviation 12.999 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: Non-HDL-C | -13.11 percent change | Standard Deviation 20.428 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: TC | -2.27 percent change | Standard Deviation 8.829 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: ApoB | -7.67 percent change | Standard Deviation 15.315 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: TG | -0.50 percent change | Standard Deviation 26.358 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: TC | -3.88 percent change | Standard Deviation 14.148 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: HDL-C | 5.88 percent change | Standard Deviation 12.764 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: HDL-C | 3.58 percent change | Standard Deviation 19.489 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: ApoA1 | 1.50 percent change | Standard Deviation 10.896 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29:Non-HDL-C | -7.57 percent change | Standard Deviation 17.933 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: TG | -8.14 percent change | Standard Deviation 37.105 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: ApoA1 | 0.57 percent change | Standard Deviation 9.918 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: ApoB | -0.61 percent change | Standard Deviation 12.068 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: HDL-C | 4.96 percent change | Standard Deviation 17.618 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: TC | -5.52 percent change | Standard Deviation 20.658 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: TG | -15.79 percent change | Standard Deviation 27.131 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: ApoB | -11.27 percent change | Standard Deviation 14.177 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: ApoA1 | 2.88 percent change | Standard Deviation 7.949 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: HDL-C | 6.01 percent change | Standard Deviation 15.077 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: TC | -3.85 percent change | Standard Deviation 18.857 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: Non-HDL-C | -8.48 percent change | Standard Deviation 24.291 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: Non-HDL-C | -6.97 percent change | Standard Deviation 23.977 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: TG | 1.66 percent change | Standard Deviation 53.893 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: ApoB | -1.51 percent change | Standard Deviation 23.582 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: ApoA1 | 5.31 percent change | Standard Deviation 11.15 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: HDL-C | 3.00 percent change | Standard Deviation 12.481 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: HDL-C | 0.27 percent change | Standard Deviation 9.02 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: TG | -1.90 percent change | Standard Deviation 37.939 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: TC | -10.62 percent change | Standard Deviation 7.813 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29:Non-HDL-C | -14.75 percent change | Standard Deviation 10.32 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: TG | -5.70 percent change | Standard Deviation 53.271 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: TG | -4.22 percent change | Standard Deviation 42.18 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: ApoB | -27.25 percent change | Standard Deviation 28.265 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: TC | -28.78 percent change | Standard Deviation 22.023 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: ApoA1 | 6.81 percent change | Standard Deviation 15.094 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: ApoA1 | 8.75 percent change | Standard Deviation 11.114 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: HDL-C | 10.67 percent change | Standard Deviation 13.967 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: TG | -15.94 percent change | Standard Deviation 34.219 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: HDL-C | 9.34 percent change | Standard Deviation 10.291 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29:Non-HDL-C | -54.06 percent change | Standard Deviation 23.588 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: TC | -24.17 percent change | Standard Deviation 22.496 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: ApoB | -44.93 percent change | Standard Deviation 18.32 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: Non-HDL-C | -34.84 percent change | Standard Deviation 31.588 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: Non-HDL-C | -41.28 percent change | Standard Deviation 27.815 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: HDL-C | 6.78 percent change | Standard Deviation 15.755 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: TC | -38.54 percent change | Standard Deviation 19.844 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: HDL-C | 10.70 percent change | Standard Deviation 17.738 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: TG | -10.76 percent change | Standard Deviation 32.71 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: Non-HDL-C | -50.16 percent change | Standard Deviation 32.255 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: ApoB | -61.17 percent change | Standard Deviation 9.142 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: TC | -53.52 percent change | Standard Deviation 7.45 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: TC | -37.36 percent change | Standard Deviation 21.167 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: ApoB | -40.06 percent change | Standard Deviation 29.448 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: TG | -14.11 percent change | Standard Deviation 40.324 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: ApoA1 | 5.55 percent change | Standard Deviation 9.613 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: Non-HDL-C | -50.78 percent change | Standard Deviation 26.254 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: HDL-C | 12.96 percent change | Standard Deviation 12.116 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: ApoA1 | 7.81 percent change | Standard Deviation 12.152 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 57: HDL-C | 11.06 percent change | Standard Deviation 15.39 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 85: TC | -36.55 percent change | Standard Deviation 26.15 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29: TG | -22.55 percent change | Standard Deviation 31.973 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Percent change at Day 29:Non-HDL-C | -73.23 percent change | Standard Deviation 9.029 |
Other Pre-specified
Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Time frame: Baseline, Day 29, 57, 71, 85, 99, 127, 141
Population: Efficacy analysis set. 'number analyzed' = participants who were evaluable for specified time points for each arm. Results for change at Day 85 in Lp(a) was not reported because data was not collected for Lp(a) at Day 85 due to an inadvertent omission in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Baseline | 37.46 mg/dL | Standard Deviation 34.809 |
| Placebo | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 141 | 2.48 mg/dL | Standard Deviation 13.753 |
| Placebo | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 127 | -3.25 mg/dL | Standard Deviation 28.197 |
| Placebo | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 57 | 1.50 mg/dL | Standard Deviation 11.677 |
| Placebo | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 29 | 3.30 mg/dL | Standard Deviation 9.837 |
| Placebo | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 71 | 1.27 mg/dL | Standard Deviation 13.458 |
| Placebo | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 99 | 2.22 mg/dL | Standard Deviation 14.847 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 99 | 4.71 mg/dL | Standard Deviation 15.625 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 71 | -0.84 mg/dL | Standard Deviation 10.351 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 29 | 2.49 mg/dL | Standard Deviation 17.63 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Baseline | 61.05 mg/dL | Standard Deviation 50.109 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 127 | 2.11 mg/dL | Standard Deviation 11.218 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 57 | -2.11 mg/dL | Standard Deviation 7.274 |
| PF-04950615 0.25 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 141 | -0.72 mg/dL | Standard Deviation 15.353 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 71 | -9.26 mg/dL | Standard Deviation 24.021 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Baseline | 63.66 mg/dL | Standard Deviation 50.594 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 29 | 2.79 mg/dL | Standard Deviation 21.729 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 57 | 0.86 mg/dL | Standard Deviation 22.192 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 99 | -1.70 mg/dL | Standard Deviation 10.73 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 127 | -0.59 mg/dL | Standard Deviation 19.654 |
| PF-04950615 1.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 141 | 0.84 mg/dL | Standard Deviation 12.11 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 57 | -3.44 mg/dL | Standard Deviation 19.032 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 99 | 4.89 mg/dL | Standard Deviation 24.93 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 29 | -5.42 mg/dL | Standard Deviation 17.801 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 141 | 3.93 mg/dL | Standard Deviation 14.947 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 127 | -6.45 mg/dL | Standard Deviation 37.106 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Baseline | 66.29 mg/dL | Standard Deviation 79.992 |
| PF-04950615 3.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 71 | -4.57 mg/dL | Standard Deviation 16.857 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 57 | -11.70 mg/dL | Standard Deviation 23.474 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 141 | -5.52 mg/dL | Standard Deviation 36.935 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 127 | -8.11 mg/dL | Standard Deviation 31.751 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 99 | -17.52 mg/dL | Standard Deviation 37.185 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 29 | -14.08 mg/dL | Standard Deviation 15.693 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Baseline | 59.73 mg/dL | Standard Deviation 72.611 |
| PF-04950615 6.0 mg/kg | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Change at Day 71 | -15.45 mg/dL | Standard Deviation 34.324 |
Other Pre-specified
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Time frame: Baseline, Day 29, 57, 71, 85, 99, 127, 141
Population: Efficacy analysis set. 'number analyzed' = participants who were evaluable for specified time points for each arm. Results for percent change at Day 85 in Lp(a) was not reported because data was not collected for Lp(a) at Day 85 due to an inadvertent omission in the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 29 | 11.56 percent change | Standard Deviation 25.846 |
| Placebo | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 57 | 5.13 percent change | Standard Deviation 20.258 |
| Placebo | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 71 | -3.14 percent change | Standard Deviation 27.897 |
| Placebo | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 99 | 0.20 percent change | Standard Deviation 23.623 |
| Placebo | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 127 | -0.08 percent change | Standard Deviation 42.026 |
| Placebo | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 141 | 7.37 percent change | Standard Deviation 28.842 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 127 | 1.84 percent change | Standard Deviation 15.518 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 141 | -2.41 percent change | Standard Deviation 20.15 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 29 | 14.10 percent change | Standard Deviation 42.815 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 71 | -3.43 percent change | Standard Deviation 14.579 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 99 | 2.66 percent change | Standard Deviation 19.043 |
| PF-04950615 0.25 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 57 | -0.02 percent change | Standard Deviation 14.398 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 99 | -3.46 percent change | Standard Deviation 19.6 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 127 | -0.14 percent change | Standard Deviation 28.16 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 29 | 4.23 percent change | Standard Deviation 22.161 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 71 | -21.42 percent change | Standard Deviation 26.676 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 57 | 1.38 percent change | Standard Deviation 21.771 |
| PF-04950615 1.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 141 | -1.27 percent change | Standard Deviation 19.554 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 99 | -6.58 percent change | Standard Deviation 5.693 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 57 | -10.60 percent change | Standard Deviation 22.427 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 71 | -18.77 percent change | Standard Deviation 23.309 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 141 | 0.50 percent change | Standard Deviation 22.445 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 127 | -11.44 percent change | Standard Deviation 31.828 |
| PF-04950615 3.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 29 | -21.34 percent change | Standard Deviation 25.694 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 127 | -12.93 percent change | Standard Deviation 27.915 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 71 | -25.95 percent change | Standard Deviation 29.676 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 57 | -23.43 percent change | Standard Deviation 27.739 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 141 | -2.41 percent change | Standard Deviation 31.08 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 99 | -25.39 percent change | Standard Deviation 22.064 |
| PF-04950615 6.0 mg/kg | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Percent change at Day 29 | -29.90 percent change | Standard Deviation 22.427 |