Heterozygous Familial Hypercholesterolemia
Conditions
Keywords
High Risk of cardiovascular events, Heterozygous familial hypercholesterolemia
Brief summary
This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.
Interventions
150 mg every 2 weeks, subcutaneous injection, 12 months
OTHERPlacebo
subcutaneous injection every 2 weeks for 12 months
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
* Treated with a statin. * Fasting LDL-C \> 70 mg/dL and triglyceride \<=400 mg/dL. * High or very high risk of incurring a cardiovascular event. * Heterozygous familial hypercholesterolemia.
Exclusion criteria
* Pregnant or breastfeeding females. * Cardiovascular or cerebrovascular event of procedures during the past 30 days. * Congestive heart failure NYHA class IV. * Poorly controlled hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline, Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Total Cholesterol (TC) at Week 12 | Baseline, Week 12 | — |
| Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | Baseline, Week 12 | — |
| Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | Baseline, Week 12 | — |
| Percent Change From Baseline in Lipoprotein (a) at Week 12 | Baseline, Week 12 | — |
| Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline, Week 12 | — |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 | Baseline, Week 24, 52 | — |
| Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52 | Baseline, Week 24, 52 | — |
| Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52 | Baseline, Week 24, 52 | — |
| Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52 | Baseline, Week 24, 52 | — |
| Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52 | Baseline, Week 24, 52 | — |
| Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52 | Baseline, Week 24, 52 | — |
| Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | — |
| Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | — |
| Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | — |
| Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | — |
| Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 | Baseline, Week 12 | — |
| Absolute Change From Baseline in Total Cholesterol (TC) at Week 12 | Baseline, Week 12 | — |
| Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) 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) at Week 12 | Baseline, Week 12 | — |
| Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline, Week 12 | — |
| Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | — |
| Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 | Baseline, Week 12, 24, 52 | — |
| Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52 | Week 12, 24, 52 | — |
| Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52 | Week 12, 24, 52 | — |
| Plasma PF-04950615 Concentrations at Week 12, 24 and 52 | Week 12, 24, 52 | — |
| Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions | Baseline up to the end of study (up to 58 weeks) | Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reaction is a reaction at the site of the subcutaneous injection and characterized by the symptoms of erythema, swelling, tenderness and warmth. Participants with any of the above type 1 or type 3 hypersensitivity reactions and participants with any of the above injection site reactions were reported in this outcome measure. |
| Percentage of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) | Baseline up to the end of study (up to 58 weeks) | Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported in this outcome measure. ADA titer greater than or equal to (\>=) 6.23 were considered as ADA positive and nAb titer level \>=1.58 were considered as nAb positive. |
Countries
Bulgaria, Canada, Finland, Italy, Netherlands, Norway, Poland, South Africa, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks. | 185 |
| PF--04950615 Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks. | 185 |
| Total | 370 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Does not meet entry criteria | 1 | 3 |
| Overall Study | Other unspecified | 1 | 2 |
| Overall Study | Withdrawal by Subject | 13 | 5 |
Baseline characteristics
| Characteristic | Placebo | PF--04950615 | Total |
|---|---|---|---|
| Age, Continuous | 55.7 years STANDARD_DEVIATION 11.2 | 56.5 years STANDARD_DEVIATION 10.5 | 56.1 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 82 Participants | 73 Participants | 155 Participants |
| Sex: Female, Male Male | 103 Participants | 112 Participants | 215 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 36 / 185 | 70 / 185 |
| serious Total, serious adverse events | 22 / 185 | 24 / 185 |
Outcome results
Primary
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized. Here, 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 Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -0.3 percent change | Standard Deviation 18.3 |
| PF--04950615 | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -54.2 percent change | Standard Deviation 29.34 |
Comparison: LS-mean difference,associated 95 percent (%) confidence intervals (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 interaction and geographical region.p-value: <0.00195% CI: [-59.5, -49.5]Mixed Model Repeated Measures (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 (n= 185, 185) | 115.9 mg/dL | Standard Deviation 35.25 |
| Placebo | Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | Change at Week 12 (n= 175, 166) | -0.9 mg/dL | Standard Deviation 20.51 |
| PF--04950615 | Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | Baseline (n= 185, 185) | 112.8 mg/dL | Standard Deviation 26.26 |
| PF--04950615 | Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | Change at Week 12 (n= 175, 166) | -53.7 mg/dL | Standard Deviation 33.07 |
Comparison: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-59.2, -48.5]
Secondary
Absolute Change From Baseline in 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 High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline (n= 185, 185) | 48.6 mg/dL | Standard Deviation 11.84 |
| Placebo | Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Change at Week 12 (n= 175, 166) | -0.6 mg/dL | Standard Deviation 6.31 |
| PF--04950615 | Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline (n= 185, 185) | 50.3 mg/dL | Standard Deviation 11.4 |
| PF--04950615 | Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Change at Week 12 (n= 175, 166) | 2.8 mg/dL | Standard Deviation 7.89 |
Comparison: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [2, 4.9]
Secondary
Absolute Change From Baseline in Lipoprotein (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) at Week 12 | Baseline (n= 184, 185) | 58.8 mg/dL | Standard Deviation 69.88 |
| Placebo | Absolute Change From Baseline in Lipoprotein (a) at Week 12 | Change at Week 12 (n= 172, 166) | -1.4 mg/dL | Standard Deviation 14.02 |
| PF--04950615 | Absolute Change From Baseline in Lipoprotein (a) at Week 12 | Baseline (n= 184, 185) | 59.7 mg/dL | Standard Deviation 63.38 |
| PF--04950615 | Absolute Change From Baseline in Lipoprotein (a) at Week 12 | Change at Week 12 (n= 172, 166) | -14.0 mg/dL | Standard Deviation 17.91 |
Comparison: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-14.7, -8.9]
Secondary
Absolute Change From Baseline in Low Density Lipoprotein (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 Low Density Lipoprotein (LDL-C) at Week 12 | Change at Week 12 (n= 175, 166) | -3.0 milligram per deciliter (mg/dL) | Standard Deviation 30.47 |
| Placebo | Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 | Baseline (n= 185, 185) | 150.0 milligram per deciliter (mg/dL) | Standard Deviation 59.75 |
| PF--04950615 | Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 | Baseline (n= 185, 185) | 144.2 milligram per deciliter (mg/dL) | Standard Deviation 41.96 |
| PF--04950615 | Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 | Change at Week 12 (n= 175, 166) | -79.1 milligram per deciliter (mg/dL) | Standard Deviation 46.97 |
Comparison: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-86.2, -71.4]
Secondary
Absolute Change From Baseline in 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 time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | Baseline (n= 185, 185) | 178.6 mg/dL | Standard Deviation 66.64 |
| Placebo | Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | Change at Week 12 (n= 175, 166) | -2.3 mg/dL | Standard Deviation 36.24 |
| PF--04950615 | Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | Baseline (n= 185, 185) | 170.4 mg/dL | Standard Deviation 45.12 |
| PF--04950615 | Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | Change at Week 12 (n= 175, 166) | -86.0 mg/dL | Standard Deviation 51.09 |
Comparison: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-95.4, -78.7]
Secondary
Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52
Time frame: Baseline, Week 12, 24, 52
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 | Baseline (n =185, 185) | 0.8 ratio | Standard Deviation 0.31 |
| Placebo | Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 | Change at Week 12 (n =175, 166) | 0.0 ratio | Standard Deviation 0.18 |
| Placebo | Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 | Change at Week 24 (n =176, 171) | 0.0 ratio | Standard Deviation 0.17 |
| Placebo | Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 | Change at Week 52 (n =169, 171) | 0.0 ratio | Standard Deviation 0.17 |
| PF--04950615 | Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 | Change at Week 52 (n =169, 171) | -0.3 ratio | Standard Deviation 0.25 |
| PF--04950615 | Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 | Baseline (n =185, 185) | 0.8 ratio | Standard Deviation 0.23 |
| PF--04950615 | Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 | Change at Week 24 (n =176, 171) | -0.4 ratio | Standard Deviation 0.25 |
| PF--04950615 | Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 | Change at Week 12 (n =175, 166) | -0.4 ratio | Standard Deviation 0.25 |
Comparison: Week 12: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-0.5, -0.4]
Comparison: Week 24:LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-0.4, -0.4]
Comparison: Week 52: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-0.4, -0.3]
Secondary
Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52
Time frame: Baseline, Week 12, 24, 52
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 | Baseline (n =185, 185) | 4.9 ratio | Standard Deviation 1.81 |
| Placebo | Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 | Change at Week 12 (n =175, 166) | 0.0 ratio | Standard Deviation 1 |
| Placebo | Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 | Change at Week 24 (n =174, 173) | 0.0 ratio | Standard Deviation 1.2 |
| Placebo | Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 | Change at Week 52 (n =169, 171) | -0.0 ratio | Standard Deviation 1 |
| PF--04950615 | Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 | Change at Week 52 (n =169, 171) | -1.5 ratio | Standard Deviation 1.35 |
| PF--04950615 | Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 | Baseline (n =185, 185) | 4.6 ratio | Standard Deviation 1.32 |
| PF--04950615 | Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 | Change at Week 24 (n =174, 173) | -1.7 ratio | Standard Deviation 1.29 |
| PF--04950615 | Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 | Change at Week 12 (n =175, 166) | -1.8 ratio | Standard Deviation 1.29 |
Comparison: Week 12: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-2.2, -1.8]
Comparison: Week 24: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-2.1, -1.6]
Comparison: Week 52: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-1.8, -1.3]
Secondary
Absolute Change From Baseline in 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 Total Cholesterol (TC) at Week 12 | Baseline (n= 185, 185) | 227.2 mg/dL | Standard Deviation 67.31 |
| Placebo | Absolute Change From Baseline in Total Cholesterol (TC) at Week 12 | Change at Week 12 (n= 175, 166) | -2.8 mg/dL | Standard Deviation 36.43 |
| PF--04950615 | Absolute Change From Baseline in Total Cholesterol (TC) at Week 12 | Baseline (n= 185, 185) | 220.7 mg/dL | Standard Deviation 46.26 |
| PF--04950615 | Absolute Change From Baseline in Total Cholesterol (TC) at Week 12 | Change at Week 12 (n= 175, 166) | -83.2 mg/dL | Standard Deviation 49.51 |
Comparison: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-91.3, -75]
Secondary
Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reaction is a reaction at the site of the subcutaneous injection and characterized by the symptoms of erythema, swelling, tenderness and warmth. Participants with any of the above type 1 or type 3 hypersensitivity reactions and participants with any of the above injection site reactions were reported in this outcome measure.
Time frame: Baseline up to the end of study (up to 58 weeks)
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 or 3 Hypersensitivity Reactions and Injection Site Reactions | With Type 1 or 3 hypersensitivity reactions | 0 participants |
| Placebo | Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions | With Injection site reactions | 1 participants |
| PF--04950615 | Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions | With Type 1 or 3 hypersensitivity reactions | 0 participants |
| PF--04950615 | Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions | With Injection site reactions | 38 participants |
Secondary
Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52
Time frame: Week 12, 24, 52
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52 | Week 24 (n =175, 173) | 13.1 percentage of participants |
| Placebo | Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52 | Week 52 (n =169, 171) | 16.6 percentage of participants |
| Placebo | Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52 | Week 12 (n =175, 166) | 13.1 percentage of participants |
| PF--04950615 | Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52 | Week 12 (n =175, 166) | 83.1 percentage of participants |
| PF--04950615 | Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52 | Week 24 (n =175, 173) | 80.9 percentage of participants |
| PF--04950615 | Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52 | Week 52 (n =169, 171) | 70.8 percentage of participants |
Comparison: Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.95% CI: [25.24, 106.1]
Comparison: Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.95% CI: [30.32, 147.43]
Comparison: Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.95% CI: [11.85, 44.01]
Secondary
Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52
Time frame: Week 12, 24, 52
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52 | Week 12 (n =175, 166) | 1.1 percentage of participants |
| Placebo | Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52 | Week 24 (n =175, 173) | 1.1 percentage of participants |
| Placebo | Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52 | Week 52 (n =169, 171) | 0.6 percentage of participants |
| PF--04950615 | Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52 | Week 12 (n =175, 166) | 66.3 percentage of participants |
| PF--04950615 | Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52 | Week 24 (n =175, 173) | 60.7 percentage of participants |
| PF--04950615 | Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52 | Week 52 (n =169, 171) | 53.2 percentage of participants |
Comparison: Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.95% CI: [47.16, 854.6]
Comparison: Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.95% CI: [51.95, 1000.39]
Comparison: Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.95% CI: [34.87, 1937.06]
Secondary
Percentage of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported in this outcome measure. ADA titer greater than or equal to (\>=) 6.23 were considered as ADA positive and nAb titer level \>=1.58 were considered as nAb positive.
Time frame: Baseline up to the end of study (up to 58 weeks)
Population: Analysis was performed on all participants who received at least 1 dose of PF-04950615.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) | With positive ADA | 49.7 percentage of participants |
| Placebo | Percentage of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) | With positive nAb | 33 percentage of participants |
Secondary
Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Time frame: Baseline, Week 12, 24, 52
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 | Week 12 (n =175, 166) | -0.5 percent change | Standard Deviation 11.7 |
| Placebo | Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 | Week 24 (n =176, 172) | -0.6 percent change | Standard Deviation 10.69 |
| Placebo | Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 | Week 52 (n =169, 171) | 0.3 percent change | Standard Deviation 12.02 |
| PF--04950615 | Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 | Week 12 (n =175, 166) | 4.8 percent change | Standard Deviation 12.15 |
| PF--04950615 | Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 | Week 24 (n =176, 172) | 3.9 percent change | Standard Deviation 10.72 |
| PF--04950615 | Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 | Week 52 (n =169, 171) | 3.0 percent change | Standard Deviation 11.53 |
Comparison: Week 12: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [2.9, 7.8]
Comparison: Week 24: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [2.5, 6.8]
Comparison: Week 52: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [0.5, 5.4]
Secondary
Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52
Time frame: Baseline, Week 12, 24, 52
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 | Week 12 (n =175, 166) | -2.6 percent change | Standard Deviation 13.34 |
| Placebo | Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 | Week 24 (n =175, 170) | -2.8 percent change | Standard Deviation 11.88 |
| Placebo | Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 | Week 52 (n =167, 171) | -3.5 percent change | Standard Deviation 11.9 |
| PF--04950615 | Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 | Week 12 (n =175, 166) | -1.6 percent change | Standard Deviation 15.68 |
| PF--04950615 | Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 | Week 24 (n =175, 170) | -1.8 percent change | Standard Deviation 13.45 |
| PF--04950615 | Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 | Week 52 (n =167, 171) | -2.4 percent change | Standard Deviation 14.5 |
Comparison: Week 12: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-2.3, 3.6]
Comparison: Week 24: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-1.9, 3.2]
Comparison: Week 52: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-1.9, 3.6]
Secondary
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized. Here, 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 Apolipoprotein B (ApoB) at Week 12 | 0.4 percent change | Standard Deviation 15.96 |
| PF--04950615 | Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 | -47.5 percent change | Standard Deviation 28.89 |
Comparison: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.p-value: <0.00195% CI: [-52.8, -43.2]MMRM
Secondary
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52
Time frame: Baseline, Week 24, 52
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52 | Week 24 (n =176, 171) | 2.6 percent change | Standard Deviation 19.29 |
| Placebo | Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52 | Week 52 (n =169, 171) | 1.7 percent change | Standard Deviation 16.45 |
| PF--04950615 | Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52 | Week 24 (n =176, 171) | -44.8 percent change | Standard Deviation 30.4 |
| PF--04950615 | Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52 | Week 52 (n =169, 171) | -39.3 percent change | Standard Deviation 28.89 |
Comparison: Week 24: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-52.1, -41.6]
Comparison: Week 52: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-45.5, -35.5]
Secondary
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized. Here, 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 High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | -0.3 percent change | Standard Deviation 12.99 |
| PF--04950615 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | 6.3 percent change | Standard Deviation 15.11 |
Comparison: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.p-value: <0.00195% CI: [4.1, 9.9]MMRM
Secondary
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52
Time frame: Baseline, Week 24, 52
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 High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52 | Week 24 (n =174, 173) | 0.9 percent change | Standard Deviation 14.19 |
| Placebo | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52 | Week 52 (n =169, 171) | 2.2 percent change | Standard Deviation 14.51 |
| PF--04950615 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52 | Week 24 (n =174, 173) | 6.6 percent change | Standard Deviation 12.85 |
| PF--04950615 | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52 | Week 52 (n =169, 171) | 4.7 percent change | Standard Deviation 14.3 |
Comparison: Week 24: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [3.1, 8.7]
Comparison: Week 52: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-0.1, 5.9]
Secondary
Percent Change From Baseline in Lipoprotein (a) at Week 12
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized. Here, 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 Lipoprotein (a) at Week 12 | 2.2 percent change | Standard Deviation 27.21 |
| PF--04950615 | Percent Change From Baseline in Lipoprotein (a) at Week 12 | -26.4 percent change | Standard Deviation 23.63 |
Comparison: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.p-value: <0.00195% CI: [-33.9, -23.2]MMRM
Secondary
Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52
Time frame: Baseline, Week 24, 52
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52 | Week 24 (n =175, 172) | 14.6 percent change | Standard Deviation 157.93 |
| Placebo | Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52 | Week 52 (n =168, 171) | 1.3 percent change | Standard Deviation 30.5 |
| PF--04950615 | Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52 | Week 24 (n =175, 172) | -21.2 percent change | Standard Deviation 48.77 |
| PF--04950615 | Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52 | Week 52 (n =168, 171) | -15.1 percent change | Standard Deviation 68.22 |
Comparison: Week 24: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-59.8, -10.3]
Comparison: Week 52: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-26.3, -4.4]
Secondary
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52
Time frame: Baseline, Week 24, 52
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 | Week 24 (n =175, 173) | 2.7 percent change | Standard Deviation 25.38 |
| Placebo | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 | Week 52 (n =169, 171) | 3.5 percent change | Standard Deviation 21.49 |
| PF--04950615 | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 | Week 24 (n =175, 173) | -50.1 percent change | Standard Deviation 32.94 |
| PF--04950615 | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 | Week 52 (n =169, 171) | -45.3 percent change | Standard Deviation 30.87 |
Comparison: Week 24: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-58.2, -46]
Comparison: Week 52: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-53.6, -42.3]
Secondary
Percent Change From Baseline in 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, 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 Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | 0.4 percent change | Standard Deviation 17.89 |
| PF--04950615 | Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 | -49.9 percent change | Standard Deviation 26.8 |
Comparison: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.p-value: <0.00195% CI: [-55.7, -46.4]MMRM
Secondary
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52
Time frame: Baseline, Week 24, 52
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52 | Week 24 (n =174, 173) | 2.4 percent change | Standard Deviation 24.06 |
| Placebo | Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52 | Week 52 (n =169, 171) | 1.2 percent change | Standard Deviation 19.25 |
| PF--04950615 | Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52 | Week 52 (n =169, 171) | -41.8 percent change | Standard Deviation 29.99 |
| PF--04950615 | Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52 | Week 24 (n =174, 173) | -46.7 percent change | Standard Deviation 29.88 |
Comparison: Week 24: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-54.1, -42.8]
Comparison: Week 52: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-47.5, -36.9]
Secondary
Percent Change From Baseline in Total Cholesterol (TC) at Week 12
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized. Here, 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 Total Cholesterol (TC) at Week 12 | -0.0 percent change | Standard Deviation 14.45 |
| PF--04950615 | Percent Change From Baseline in Total Cholesterol (TC) at Week 12 | -37.0 percent change | Standard Deviation 19.82 |
Comparison: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.p-value: <0.00195% CI: [-41.1, -34.1]MMRM
Secondary
Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52
Time frame: Baseline, Week 24, 52
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52 | Week 24 (n =176, 173) | 1.6 percent change | Standard Deviation 19.1 |
| Placebo | Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52 | Week 52 (n =169, 171) | 1.2 percent change | Standard Deviation 15.82 |
| PF--04950615 | Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52 | Week 24 (n =176, 173) | -34.4 percent change | Standard Deviation 21.44 |
| PF--04950615 | Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52 | Week 52 (n =169, 171) | -31.0 percent change | Standard Deviation 21.5 |
Comparison: Week 24: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-40, -31.6]
Comparison: Week 52: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-35.8, -27.8]
Secondary
Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52
Time frame: Baseline, Week 12, 24, 52
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52 | Week 12 (n =175, 166) | 7.1 percent change | Standard Deviation 41.23 |
| Placebo | Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52 | Week 24 (n =176, 173) | 7.6 percent change | Standard Deviation 51.97 |
| Placebo | Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52 | Week 52 (n =169, 171) | 4.9 percent change | Standard Deviation 33.03 |
| PF--04950615 | Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52 | Week 12 (n =175, 166) | -8.7 percent change | Standard Deviation 38.07 |
| PF--04950615 | Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52 | Week 24 (n =176, 173) | -9.0 percent change | Standard Deviation 40.01 |
| PF--04950615 | Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52 | Week 52 (n =169, 171) | -3.4 percent change | Standard Deviation 58.27 |
Comparison: Week 12: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-25.3, -8.7]
Comparison: Week 24: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-27, -7.8]
Comparison: Week 52: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-19.4, 0.4]
Secondary
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52
Time frame: Baseline, Week 12, 24, 52
Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 | Week 12 (n =175, 166) | 7.1 percent change | Standard Deviation 41.23 |
| Placebo | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 | Week 24 (n =176, 173) | 7.6 percent change | Standard Deviation 51.97 |
| Placebo | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 | Week 52 (n =169, 171) | 4.9 percent change | Standard Deviation 33.03 |
| PF--04950615 | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 | Week 12 (n =175, 166) | -8.7 percent change | Standard Deviation 38.07 |
| PF--04950615 | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 | Week 24 (n =176, 173) | -9.0 percent change | Standard Deviation 40.01 |
| PF--04950615 | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 | Week 52 (n =169, 171) | -3.4 percent change | Standard Deviation 58.27 |
Comparison: Week 12: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-25.3, -8.7]
Comparison: Week 24: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-27, -7.8]
Comparison: Week 52: LS-mean difference,associated 95% confidence intervals (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 interaction and geographical region.95% CI: [-19.4, 0.4]
Secondary
Plasma PF-04950615 Concentrations at Week 12, 24 and 52
Time frame: Week 12, 24, 52
Population: Analysis was performed on all participants who received at least 1 dose of PF-04950615. Here, 'n' signifies those participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Plasma PF-04950615 Concentrations at Week 12, 24 and 52 | Week 12 (n =163) | 6.23 microgram per milliliter | Standard Deviation 5.657 |
| Placebo | Plasma PF-04950615 Concentrations at Week 12, 24 and 52 | Week 24 (n =167) | 7.00 microgram per milliliter | Standard Deviation 6.351 |
| Placebo | Plasma PF-04950615 Concentrations at Week 12, 24 and 52 | Week 52 (n =171) | 4.84 microgram per milliliter | Standard Deviation 5.384 |