| Primary | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | | FAS included all participants who were randomized. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | percent (%) change | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0002.4± 12.86
- OG001-52.0± 22.75
- OG002-32.6± 20.98
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | MMRM | Mixed Model Repeated Measures (MMRM) | <0.001 | | Least Square (LS) Mean Difference | -54.5 | Standard Error of the Mean | 2.82 | 2-Sided | 95 | -60.1 | -49.0 | | | LS-mean differences,associated 95% confidence interval (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit,treatment group*visit interaction,baseline value, baseline value*visit*group interaction, country. | | Superiority or Other | | |
|
| Secondary | Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Week 12, 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Week 12, 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Week 12, 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Week 12, 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Week 12, 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 | | FAS included all participants who were randomized. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Week 12, 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Week 12, 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Week 12, 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | percent change | | Baseline, Week 12, 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified timepoint for each arm, respectively. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Absolute Change From Baseline in Fasting Triglycerides (TG) at Week 12 | | Due to changes in planned analyses the data was not collected for this outcome measure. | Posted | | | | | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | ratio | | Baseline, Week 12, 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Mean | Standard Deviation | ratio | | Baseline, Week 12, 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| 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 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Number | | percentage of participants | | Week 12, 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| 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 | | FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively. | Posted | | Number | | percentage of participants | | Week 12, 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mcg/mL | | Week 12 and 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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 | | Safety analysis set included all participants who received at least 1 dose of study treatment. | Posted | | Number | | participants | | Baseline (Day 1) up to Week 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| 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. | 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. | Posted | | Number | | participants | | Baseline up to Week 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | titer | | Week 4, 12, 24 and 30 (Follow-up) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations | | Safety analysis set included all participants who received at least 1 dose of study treatment. | Posted | | Number | | percentage of participants | | Baseline (Day 1) up to Week 30 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |