Hyperlipidemia
Conditions
Keywords
Hyperlipidemia, statin intolerance
Brief summary
This study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are statin intolerant.
Interventions
150 mg every 2 weeks by subcutaneous injection for 24 weeks
DRUGAtorvastatin
Atorvastatin PO QD
OTHERPlacebo for Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks by subcutaneous injection for 24 weeks
PO QD
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hyperlipidemia * Statin Intolerant * Fasting LDL-C \> = 70 mg/dL Fasting TG \< = 400 mg/dL
Exclusion criteria
* Pregnant or breastfeeding females * Cardiovascular or cerebrovascular event or procedure within 90 days * Severe or life-threatening adverse events with past use of statins * Poorly controlled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline, Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24 | Baseline, Week 12, 24 | — |
| Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24 | Baseline, Week 12, 24 | — |
| Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24 | Baseline, Week 12, 24 | — |
| Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24 | Baseline, Week 12, 24 | — |
| Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 | Baseline, Week 24 | — |
| Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24 | Baseline, Week 12, 24 | — |
| Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24 | Baseline, Week 12, 24 | — |
| Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24 | Baseline, Week 12, 24 | — |
| Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24 | Baseline, Week 12, 24 | — |
| Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline, Week 12 | — |
| Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 | Baseline, Week 12 | — |
| Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline, Week 12 | — |
| Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24 | Baseline, Week 12, 24 | — |
| Absolute Change From Baseline in Fasting Triglycerides (TG) at Week 12 | Baseline, Week 12 | — |
| Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | Baseline, Week 12 | — |
| Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12 | Baseline, Week 12 | — |
| Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 | Baseline, Week 12, 24 | — |
| Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 | Baseline, Week 12, 24 | — |
| Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 | Week 12, 24 | — |
| Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 | Week 12, 24 | — |
| Plasma PF-04950615 Concentrations at Weeks 12 and 24 | Week 12 and 24 | Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.4 micrograms per milliliter \[mcg/mL\]) to zero. Participants who received PF-04950615 150 mg were evaluable for this outcome measure. |
| Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Baseline (Day 1) up to Week 30 | — |
| Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb) | Baseline up to Week 30 | Participants with at least one positive ADA titer greater than or equal to (\>=) 6.23 or positive nAb titer \>=4.32 were reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint. |
| Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively | Week 4, 12, 24 and 30 (Follow-up) | Titer levels of participants who tested positive for ADA and nAb are reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint. |
| Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Baseline (Day 1) up to Week 30 | — |
| Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | Baseline, Week 12 | — |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received single dose of placebo matched to PF-04950615 subcutaneous (SC) injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks. | 73 |
| PF-04950615 150 Milligram (mg) + Placebo Participants received single dose of PF-04950615 150 mg SC injection every 2 weeks along with placebo matched to Atorvastatin tablet once daily for up to 24 weeks. | 74 |
| Atorvastatin 40 mg + Placebo Participants received single dose of Atorvastatin 40 mg tablet once daily along with placebo matched to PF-04950615 SC injection every 2 weeks for up to 24 weeks. | 37 |
| Total | 184 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 2 |
| Overall Study | Death | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Other | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | PF-04950615 150 Milligram (mg) + Placebo | Atorvastatin 40 mg + Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 8.4 | 64 years STANDARD_DEVIATION 9.2 | 65.1 years STANDARD_DEVIATION 7.6 | 63.9 years STANDARD_DEVIATION 8.5 |
| Sex: Female, Male Female | 38 Participants | 40 Participants | 21 Participants | 99 Participants |
| Sex: Female, Male Male | 35 Participants | 34 Participants | 16 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 44 / 73 | 41 / 74 | 20 / 36 |
| serious Total, serious adverse events | 7 / 73 | 8 / 74 | 1 / 36 |
Outcome results
Primary
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | 2.4 percent (%) change | Standard Deviation 12.86 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -52.0 percent (%) change | Standard Deviation 22.75 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -32.6 percent (%) change | Standard Deviation 20.98 |
p-value: <0.00195% CI: [-60.1, -49]MMRM
Secondary
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | Baseline | 133.3 mg/dL | Standard Deviation 27 |
| Placebo | Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | Change at Week 12 | 1.1 mg/dL | Standard Deviation 15.08 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | Baseline | 125.8 mg/dL | Standard Deviation 31.43 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | Change at Week 12 | -57.5 mg/dL | Standard Deviation 28.57 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | Baseline | 124.6 mg/dL | Standard Deviation 29.82 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | Change at Week 12 | -35.3 mg/dL | Standard Deviation 25.66 |
Comparison: Week 1295% CI: [-66, -52.4]
Secondary
Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24
Time frame: Baseline, Week 12, 24
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 | Absolute change at Week 12 | -0.0 ratio | Standard Deviation 0.1 |
| Placebo | Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 | Baseline | 0.9 ratio | Standard Deviation 0.25 |
| Placebo | Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 | Absolute change at Week 24 | -0.0 ratio | Standard Deviation 0.12 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 | Absolute change at Week 12 | -0.4 ratio | Standard Deviation 0.21 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 | Baseline | 0.9 ratio | Standard Deviation 0.24 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 | Absolute change at Week 24 | -0.4 ratio | Standard Deviation 0.25 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 | Baseline | 0.8 ratio | Standard Deviation 0.21 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 | Absolute change at Week 24 | -0.2 ratio | Standard Deviation 0.18 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 | Absolute change at Week 12 | -0.2 ratio | Standard Deviation 0.17 |
Comparison: Week 1295% CI: [-0.5, -0.4]
Comparison: Week 2495% CI: [-0.4, -0.3]
Secondary
Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline | 51.6 mg/dL | Standard Deviation 13.92 |
| Placebo | Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Change at Week 12 | 0.1 mg/dL | Standard Deviation 6.31 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline | 51.1 mg/dL | Standard Deviation 15.02 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Change at Week 12 | 6.0 mg/dL | Standard Deviation 8.01 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline | 55.7 mg/dL | Standard Deviation 13.5 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Change at Week 12 | -0.5 mg/dL | Standard Deviation 7.07 |
Comparison: Week 1295% CI: [3.7, 8]
Secondary
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline | 182.1 milligrams per deciliter (mg/dL) | Standard Deviation 46.96 |
| Placebo | Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Change at Week 12 | 3.1 milligrams per deciliter (mg/dL) | Standard Deviation 21.12 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline | 168.8 milligrams per deciliter (mg/dL) | Standard Deviation 47.31 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Change at Week 12 | -88.0 milligrams per deciliter (mg/dL) | Standard Deviation 43.82 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline | 169.9 milligrams per deciliter (mg/dL) | Standard Deviation 46.44 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Change at Week 12 | -56.5 milligrams per deciliter (mg/dL) | Standard Deviation 40.68 |
Comparison: Week 1295% CI: [-103.5, -84.1]
Secondary
Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified timepoint for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | Baseline | 210.7 mg/dL | Standard Deviation 49.75 |
| Placebo | Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | Change at Week 12 | 2.2 mg/dL | Standard Deviation 22.69 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | Baseline | 199.2 mg/dL | Standard Deviation 50.4 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | Change at Week 12 | -99.8 mg/dL | Standard Deviation 46.99 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | Baseline | 200.5 mg/dL | Standard Deviation 50.16 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | Change at Week 12 | -67.1 mg/dL | Standard Deviation 45.59 |
Comparison: Week 1295% CI: [-114.6, -92.7]
Secondary
Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 | Baseline | 262.3 mg/dL | Standard Deviation 51.2 |
| Placebo | Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 | Change at Week 12 | 3.2 mg/dL | Standard Deviation 25.46 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 | Baseline | 250.1 mg/dL | Standard Deviation 54.5 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 | Change at Week 12 | -93.8 mg/dL | Standard Deviation 47.94 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 | Baseline | 256.2 mg/dL | Standard Deviation 53.55 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 | Change at Week 12 | -67.7 mg/dL | Standard Deviation 46.85 |
Comparison: Week 1295% CI: [-109.9, -87.5]
Secondary
Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24
Time frame: Baseline, Week 12, 24
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 | Absolute change at Week 12 | 0.1 ratio | Standard Deviation 0.76 |
| Placebo | Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 | Baseline | 5.4 ratio | Standard Deviation 1.53 |
| Placebo | Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 | Absolute change at Week 24 | 0.0 ratio | Standard Deviation 0.77 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 | Absolute change at Week 12 | -2.3 ratio | Standard Deviation 1.13 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 | Baseline | 5.2 ratio | Standard Deviation 1.45 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 | Absolute change at Week 24 | -2.0 ratio | Standard Deviation 1.35 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 | Baseline | 4.8 ratio | Standard Deviation 1.27 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 | Absolute change at Week 24 | -1.3 ratio | Standard Deviation 1.13 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 | Absolute change at Week 12 | -1.3 ratio | Standard Deviation 1.13 |
Comparison: Week 1295% CI: [-2.7, -2.1]
Comparison: Week 2495% CI: [-2.4, -1.7]
Secondary
Absolute Change From Baseline in Fasting Triglycerides (TG) at Week 12
Time frame: Baseline, Week 12
Population: Due to changes in planned analyses the data was not collected for this outcome measure.
Secondary
Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12 | Baseline | 32.0 mg/dL | Standard Deviation 38.46 |
| Placebo | Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12 | Change at Week 12 | 0.7 mg/dL | Standard Deviation 5.19 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12 | Baseline | 27.1 mg/dL | Standard Deviation 36.31 |
| PF-04950615 150 Milligram (mg) + Placebo | Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12 | Change at Week 12 | -5.8 mg/dL | Standard Deviation 7.93 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12 | Baseline | 31.7 mg/dL | Standard Deviation 38.26 |
| Atorvastatin 40 mg + Placebo | Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12 | Change at Week 12 | 1.9 mg/dL | Standard Deviation 5.27 |
Comparison: Week 1295% CI: [-8.7, -4.5]
Secondary
Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively
Titer levels of participants who tested positive for ADA and nAb are reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.
Time frame: Week 4, 12, 24 and 30 (Follow-up)
Population: Safety analysis set: all participants who received at least 1 dose of study treatment. Here, 'N' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time point for the arm. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively | ADA Titer: Week 30 | 10.12 titer | Standard Deviation 2.981 |
| Placebo | Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively | ADA Titer: Week 4 | 9.94 titer | Standard Deviation 1.181 |
| Placebo | Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively | ADA Titer: Week 12 | 9.49 titer | Standard Deviation 1.646 |
| Placebo | Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively | ADA Titer: Week 24 | 9.46 titer | Standard Deviation 2.196 |
| Placebo | Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively | nAb Titer: Week 12 | 6.05 titer | Standard Deviation 2.44 |
| Placebo | Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively | nAb Titer: Week 24 | 5.28 titer | Standard Deviation 1.358 |
| Placebo | Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively | nAb Titer: Week 30 | 6.09 titer | Standard Deviation 2.135 |
Secondary
Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations
Time frame: Baseline (Day 1) up to Week 30
Population: Safety analysis set included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | CK Elevations | 0 participants |
| Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Type 1 and 3 hypersensitivity reactions | 1 participants |
| Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Injection site reactions | 4 participants |
| Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Myalgia | 13 participants |
| Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Myopathy | 0 participants |
| Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | LFT Elevations | 1 participants |
| PF-04950615 150 Milligram (mg) + Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Myalgia | 13 participants |
| PF-04950615 150 Milligram (mg) + Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | CK Elevations | 1 participants |
| PF-04950615 150 Milligram (mg) + Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | LFT Elevations | 2 participants |
| PF-04950615 150 Milligram (mg) + Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Myopathy | 0 participants |
| PF-04950615 150 Milligram (mg) + Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Type 1 and 3 hypersensitivity reactions | 0 participants |
| PF-04950615 150 Milligram (mg) + Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Injection site reactions | 16 participants |
| Atorvastatin 40 mg + Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Type 1 and 3 hypersensitivity reactions | 0 participants |
| Atorvastatin 40 mg + Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Injection site reactions | 0 participants |
| Atorvastatin 40 mg + Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | CK Elevations | 0 participants |
| Atorvastatin 40 mg + Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Myalgia | 7 participants |
| Atorvastatin 40 mg + Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | LFT Elevations | 1 participants |
| Atorvastatin 40 mg + Placebo | Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Myopathy | 0 participants |
Secondary
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Participants with at least one positive ADA titer greater than or equal to (\>=) 6.23 or positive nAb titer \>=4.32 were reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.
Time frame: Baseline up to Week 30
Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Here, 'N' signifies those participants who were evaluable for this outcome measure. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb) | ADA | 35 participants |
| Placebo | Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb) | nAb | 21 participants |
Secondary
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24
Time frame: Week 12, 24
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 | Week 12 | 1.4 percentage of participants |
| Placebo | Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 | Week 24 | 0 percentage of participants |
| PF-04950615 150 Milligram (mg) + Placebo | Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 | Week 12 | 71.8 percentage of participants |
| PF-04950615 150 Milligram (mg) + Placebo | Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 | Week 24 | 61.4 percentage of participants |
| Atorvastatin 40 mg + Placebo | Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 | Week 12 | 42.9 percentage of participants |
| Atorvastatin 40 mg + Placebo | Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 | Week 24 | 45.5 percentage of participants |
Secondary
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24
Time frame: Week 12, 24
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 | Week 12 | 0 percentage of participants |
| Placebo | Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 | Week 24 | 0 percentage of participants |
| PF-04950615 150 Milligram (mg) + Placebo | Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 | Week 12 | 45.1 percentage of participants |
| PF-04950615 150 Milligram (mg) + Placebo | Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 | Week 24 | 41.4 percentage of participants |
| Atorvastatin 40 mg + Placebo | Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 | Week 12 | 14.3 percentage of participants |
| Atorvastatin 40 mg + Placebo | Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 | Week 24 | 15.2 percentage of participants |
Secondary
Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations
Time frame: Baseline (Day 1) up to Week 30
Population: Safety analysis set included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | LFT Elevations | 0 percentage of participants | — |
| Placebo | Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Myalgia | 9.6 percentage of participants | 0.1 |
| Placebo | Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Myopathy | 0 percentage of participants | 0.12 |
| Placebo | Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | CK Elevations | 0 percentage of participants | — |
| PF-04950615 150 Milligram (mg) + Placebo | Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Myalgia | 10.8 percentage of participants | 0.21 |
| PF-04950615 150 Milligram (mg) + Placebo | Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Myopathy | 0 percentage of participants | 0.25 |
| PF-04950615 150 Milligram (mg) + Placebo | Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | CK Elevations | 0 percentage of participants | — |
| PF-04950615 150 Milligram (mg) + Placebo | Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | LFT Elevations | 0 percentage of participants | — |
| Atorvastatin 40 mg + Placebo | Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | CK Elevations | 0 percentage of participants | — |
| Atorvastatin 40 mg + Placebo | Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Myopathy | 0 percentage of participants | 0.18 |
| Atorvastatin 40 mg + Placebo | Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | LFT Elevations | 0 percentage of participants | — |
| Atorvastatin 40 mg + Placebo | Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | Myalgia | 16.7 percentage of participants | 0.17 |
Secondary
Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24
Time frame: Baseline, Week 12, 24
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24 | Percent change at Week 12 | 1.9 percent change | Standard Deviation 11.38 |
| Placebo | Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24 | Percent change at Week 24 | 2.3 percent change | Standard Deviation 11.91 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24 | Percent change at Week 12 | 8.0 percent change | Standard Deviation 14.94 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24 | Percent change at Week 24 | 8.0 percent change | Standard Deviation 14.66 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24 | Percent change at Week 12 | -2.8 percent change | Standard Deviation 11.66 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24 | Percent change at Week 24 | -2.2 percent change | Standard Deviation 11.66 |
Comparison: Week 1295% CI: [2.2, 10.1]
Comparison: Week 2495% CI: [1.5, 9.7]
Secondary
Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24
Time frame: Baseline, Week 12, 24
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24 | Percent change at Week 12 | -0.4 percent change | Standard Deviation 10.83 |
| Placebo | Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24 | Percent change at Week 24 | -2.2 percent change | Standard Deviation 12.8 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24 | Percent change at Week 12 | 4.1 percent change | Standard Deviation 13.45 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24 | Percent change at Week 24 | 3.9 percent change | Standard Deviation 13.21 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24 | Percent change at Week 12 | -3.2 percent change | Standard Deviation 12.78 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24 | Percent change at Week 24 | -0.6 percent change | Standard Deviation 19.96 |
Comparison: Week 1295% CI: [0.8, 8.7]
Comparison: Week 2495% CI: [2.4, 10.5]
Secondary
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24
Time frame: Baseline, Week 12, 24
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24 | Percent change at Week 12 | 0.9 percent change | Standard Deviation 11.64 |
| Placebo | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24 | Percent change at Week 24 | 0.1 percent change | Standard Deviation 13.34 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24 | Percent change at Week 12 | -46.0 percent change | Standard Deviation 22.19 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24 | Percent change at Week 24 | -39.1 percent change | Standard Deviation 26.85 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24 | Percent change at Week 12 | -27.2 percent change | Standard Deviation 18.75 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24 | Percent change at Week 24 | -28.1 percent change | Standard Deviation 20.2 |
Comparison: Week 12p-value: <0.00195% CI: [-51.9, -41.1]MMRM
Comparison: Week 2495% CI: [-45.4, -33.2]
Secondary
Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24
Time frame: Baseline, Week 12, 24
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24 | Percent change at Week 12 | 0.4 percent change | Standard Deviation 12.31 |
| Placebo | Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24 | Percent change at Week 24 | -0.3 percent change | Standard Deviation 12.34 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24 | Percent change at Week 12 | 13.2 percent change | Standard Deviation 19.73 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24 | Percent change at Week 24 | 11.5 percent change | Standard Deviation 18.84 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24 | Percent change at Week 12 | 0.4 percent change | Standard Deviation 13.51 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24 | Percent change at Week 24 | 0.2 percent change | Standard Deviation 14.02 |
Comparison: Week 12p-value: <0.00195% CI: [7.8, 17]MMRM
Comparison: Week 2495% CI: [6.7, 16.4]
Secondary
Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24
Time frame: Baseline, Week 12, 24
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24 | Percent change at Week 12 | 2.0 percent change | Standard Deviation 33.13 |
| Placebo | Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24 | Percent change at Week 24 | 0.8 percent change | Standard Deviation 34.59 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24 | Percent change at Week 24 | -16.6 percent change | Standard Deviation 31.71 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24 | Percent change at Week 12 | -21.5 percent change | Standard Deviation 39.77 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24 | Percent change at Week 24 | 4.1 percent change | Standard Deviation 31.33 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24 | Percent change at Week 12 | 5.1 percent change | Standard Deviation 29.77 |
Comparison: Week 12p-value: <0.00195% CI: [-35.7, -10.8]MMRM
Comparison: Week 2495% CI: [-29.6, -5.1]
Secondary
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24
Time frame: Baseline, Week 24
Population: FAS included all participants who were randomized. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 | 1.6 percent change | Standard Deviation 15.62 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 | -42.7 percent change | Standard Deviation 29.5 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 | -33.3 percent change | Standard Deviation 20.91 |
Comparison: Week 2495% CI: [-51.3, -38.2]
Secondary
Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24
Time frame: Baseline, Week 12, 24
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24 | Percent change at Week 24 | -0.3 percent change | Standard Deviation 14.46 |
| Placebo | Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24 | Percent change at Week 12 | 1.1 percent change | Standard Deviation 11.16 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24 | Percent change at Week 12 | -50.0 percent change | Standard Deviation 21.06 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24 | Percent change at Week 24 | -41.9 percent change | Standard Deviation 26 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24 | Percent change at Week 12 | -32.5 percent change | Standard Deviation 21.24 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24 | Percent change at Week 24 | -34.0 percent change | Standard Deviation 21.14 |
Comparison: Week 12p-value: <0.00195% CI: [-56.3, -46]MMRM
Comparison: Week 2495% CI: [-47.7, -35.8]
Secondary
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24
Time frame: Baseline, Week 12, 24
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24 | Percent change at Week 12 | 1.3 percent change | Standard Deviation 9.92 |
| Placebo | Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24 | Percent change at Week 24 | -0.5 percent change | Standard Deviation 11.77 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24 | Percent change at Week 12 | -37.0 percent change | Standard Deviation 17.08 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24 | Percent change at Week 24 | -31.2 percent change | Standard Deviation 21.31 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24 | Percent change at Week 12 | -25.7 percent change | Standard Deviation 16.98 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24 | Percent change at Week 24 | -26.8 percent change | Standard Deviation 16.64 |
Comparison: Week 12p-value: <0.00195% CI: [-42.6, -34.2]MMRM
Comparison: Week 2495% CI: [-35.9, -26.2]
Secondary
Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24
Time frame: Baseline, Week 12, 24
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24 | Percent change at Week 12 | 2.2 percent change | Standard Deviation 26.77 |
| Placebo | Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24 | Percent change at Week 24 | -3.3 percent change | Standard Deviation 30.01 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24 | Percent change at Week 12 | -12.5 percent change | Standard Deviation 27.42 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24 | Percent change at Week 24 | -13.6 percent change | Standard Deviation 40.58 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24 | Percent change at Week 12 | -20.7 percent change | Standard Deviation 23.96 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24 | Percent change at Week 24 | -21.9 percent change | Standard Deviation 30.19 |
Comparison: Week 1295% CI: [-23.5, -5.2]
Comparison: Week 2495% CI: [-19.8, 0.4]
Secondary
Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24
Time frame: Baseline, Week 12, 24
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24 | Percent change at Week 12 | 2.2 percent change | Standard Deviation 26.77 |
| Placebo | Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24 | Percent change at Week 24 | -3.3 percent change | Standard Deviation 30.01 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24 | Percent change at Week 12 | -12.5 percent change | Standard Deviation 27.42 |
| PF-04950615 150 Milligram (mg) + Placebo | Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24 | Percent change at Week 24 | -13.6 percent change | Standard Deviation 40.58 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24 | Percent change at Week 12 | -20.7 percent change | Standard Deviation 23.96 |
| Atorvastatin 40 mg + Placebo | Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24 | Percent change at Week 24 | -21.9 percent change | Standard Deviation 30.19 |
Comparison: Week 1295% CI: [-23.5, -5.2]
Comparison: Week 2495% CI: [-19.8, 0.4]
Secondary
Plasma PF-04950615 Concentrations at Weeks 12 and 24
Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.4 micrograms per milliliter \[mcg/mL\]) to zero. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.
Time frame: Week 12 and 24
Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Here, 'N' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time point for the arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Plasma PF-04950615 Concentrations at Weeks 12 and 24 | Week 12 | 10.21 mcg/mL | Standard Deviation 9.309 |
| Placebo | Plasma PF-04950615 Concentrations at Weeks 12 and 24 | Week 24 | 7.38 mcg/mL | Standard Deviation 7.89 |