Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events (SPIRE-HR)

• ClinicalTrials.gov Identifier: NCT01968954
• Recruitment Status: Completed
• First Posted: October 24, 2013
• Results First Posted: May 17, 2017
• Last Update Posted: May 17, 2017
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hyperlipidemia
• Interventions: Drug: Bococizumab (PF-04950615;RN316); Other: Placebo
• Enrollment: 711

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Period Title: Overall Study
Started	354	357
Treated	353	356
Completed	314	314
Not Completed	40	43
Reason Not Completed
Adverse Event	6	3
Death	1	2
Lost to Follow-up	6	4
Withdrawal by Subject	20	23
Other	7	8
Protocol Violation	0	1
Did not met inclusion criteria	0	2

Baseline Characteristics

Arm/Group Title		Placebo	PF-04950615 150 mg	Total
Arm/Group Description		Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		354	357	711
Baseline Analysis Population Description		Full analysis set (FAS) included all participants who were randomized.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	354 participants	357 participants	711 participants
		61.5 (9.7)	61.1 (10.2)	61.3 (10.0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	354 participants	357 participants	711 participants
	Female	130 36.7%	136 38.1%	266 37.4%
	Male	224 63.3%	221 61.9%	445 62.6%

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12
Description	[Not Specified]
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	329	336
Mean (Standard Deviation); Unit of Measure: percent change
	1.0 (20.89)	-55.6 (29.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Model Repeated Measures (MMRM)
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Square (LS) Mean Difference
	Estimated Value	-57.0
	Confidence Interval	(2-Sided) 95%; -61.0 to -53.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.00
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: percent change
Week 12 (n =330, 340)	1.0 (14.85)	-35.1 (19.23)
Week 24 (n =331, 337)	3.2 (19.35)	-31.7 (20.47)
Week 52 (n =313, 315)	1.8 (18.50)	-27.3 (23.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-36.2
	Confidence Interval	(2-Sided) 95%; -38.8 to -33.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.33
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-34.7
	Confidence Interval	(2-Sided) 95%; -37.7 to -31.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.52
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-29.0
	Confidence Interval	(2-Sided) 95%; -32.3 to -25.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.69
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: percent change
Week 12 (n =330, 339)	1.3 (19.53)	-50.0 (26.28)
Week 24 (n =329, 336)	4.7 (27.81)	-46.2 (28.52)
Week 52 (n =312, 314)	2.3 (25.22)	-38.9 (33.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-51.6
	Confidence Interval	(2-Sided) 95%; -55.2 to -48.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.80
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean Difference
	Estimated Value	-50.6
	Confidence Interval	(2-Sided) 95%; -54.9 to -46.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.15
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 52:LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-41.2
	Confidence Interval	(2-Sided) 95%; -45.8 to -36.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.38
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: percent change
Week 12 (n =330, 339)	0.3 (19.10)	-51.1 (27.62)
Week 24 (n =331, 335)	3.5 (22.39)	-47.3 (30.43)
Week 52 (n =313, 313)	1.9 (22.25)	-39.1 (33.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-51.5
	Confidence Interval	(2-Sided) 95%; -55.1 to -47.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.84
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-50.6
	Confidence Interval	(2-Sided) 95%; -54.6 to -46.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.05
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-40.8
	Confidence Interval	(2-Sided) 95%; -45.2 to -36.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.26
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: percent change
Week 12 (n =330, 339)	4.7 (84.86)	1.9 (508.44)
Week 24 (n =331, 336)	1.9 (51.82)	4.4 (465.24)
Week 52 (n =311, 311)	1.1 (42.47)	17.3 (562.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.860
	Comments	[Not Specified]
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-2.9
	Confidence Interval	(2-Sided) 95%; -35.4 to 29.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 16.55
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	2.1
	Confidence Interval	(2-Sided) 95%; -47.2 to 51.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 25.11
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	12.9
	Confidence Interval	(2-Sided) 95%; -44.5 to 70.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 29.25
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: percent change
Week 12 (n= 330, 339)	1.9 (17.24)	6.6 (14.24)
Week 24 (n =329, 336)	1.0 (15.78)	7.8 (15.91)
Week 52 (n =312, 314)	2.0 (15.73)	5.3 (16.59)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	4.7
	Confidence Interval	(2-Sided) 95%; 2.4 to 7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.19
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	6.8
	Confidence Interval	(2-Sided) 95%; 4.5 to 9.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.18
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	3.3
	Confidence Interval	(2-Sided) 95%; 0.9 to 5.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.25
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia
Description	Participants with primary hyperlipidemia are defined as participants with triglycerides (TG) level less than (<) 200 milligram per decilitre (mg/dL) (2.26 millimoles per litre [mmol/L]) at pre-randomization.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	262	266
Mean (Standard Deviation); Unit of Measure: percent change
	1.5 (20.89)	-56.8 (27.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-59.1
	Confidence Interval	(2-Sided) 95%; -63.4 to -54.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.19
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia
Description	Participants with mixed dyslipidemia are defined as TG level greater than or equal to (>=) 200 mg/dL (2.26 mmol/L) at pre-randomization.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	67	70
Mean (Standard Deviation); Unit of Measure: percent change
	-1.0 (20.95)	-50.9 (33.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-48.7
	Confidence Interval	(2-Sided) 95%; -58.0 to -39.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.72
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: percent change
Week 24 (n =331, 336)	6.3 (32.52)	-50.0 (31.36)
Week 52 (n =311, 313)	5.2 (29.69)	-40.9 (38.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-56.0
	Confidence Interval	(2-Sided) 95%; -60.8 to -51.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.45
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-46.4
	Confidence Interval	(2-Sided) 95%; -51.8 to -41.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.77
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off
Description	Percent change from baseline in fasting LDL-C among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.
Time Frame	Baseline, Week 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: percent change
TG <200 mg/dL: Week 24 (n =261, 265)	7.2 (34.38)	-50.8 (30.90)
TG <200 mg/dL: Week 52(n =243, 248)	6.2 (29.95)	-41.1 (38.35)
TG >=200 mg/dL: Week 24(n =70, 71)	3.0 (24.30)	-46.9 (33.05)
TG >=200 mg/dL: Week 52(n =68, 65)	2.0 (28.74)	-40.1 (37.01)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	TG <200 mg/dL (Week 24): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-57.6
	Confidence Interval	(2-Sided) 95%; -63.1 to -52.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.82
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	TG <200 mg/dL (Week 52): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-47.7
	Confidence Interval	(2-Sided) 95%; -53.9 to -41.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.16
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	TG >=200 mg/dL (Week 24): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-49.3
	Confidence Interval	(2-Sided) 95%; -58.9 to -39.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.83
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	TG >=200 mg/dL (Week 52): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-41.2
	Confidence Interval	(2-Sided) 95%; -52.2 to -30.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.60
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: percent change
Week 12 (n =330, 340)	5.9 (34.90)	-9.4 (42.00)
Week 24 (n =331, 336)	7.0 (37.79)	-13.8 (33.24)
Week 52 (n =313, 315)	0.6 (38.33)	-9.3 (48.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-14.2
	Confidence Interval	(2-Sided) 95%; -19.9 to -8.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.88
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-19.9
	Confidence Interval	(2-Sided) 95%; -25.1 to -14.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.65
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-9.2
	Confidence Interval	(2-Sided) 95%; -15.7 to -2.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.31
	Estimation Comments	[Not Specified]

12. Secondary Outcome

Title	Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: percent change
Week 12 (n =330, 339)	-0.3 (14.05)	3.7 (12.56)
Week 24 (n =331, 336)	-0.8 (12.77)	4.3 (12.25)
Week 52 (n =313, 313)	0.4 (13.13)	3.3 (13.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	3.7
	Confidence Interval	(2-Sided) 95%; 1.8 to 5.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.00
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	4.9
	Confidence Interval	(2-Sided) 95%; 3.1 to 6.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.91
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	2.6
	Confidence Interval	(2-Sided) 95%; 0.7 to 4.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.98
	Estimation Comments	[Not Specified]

13. Secondary Outcome

Title	Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: percent change
Week 12 (n =327, 339)	-1.8 (12.92)	-1.9 (12.10)
Week 24 (n =331, 335)	-3.7 (14.40)	-1.9 (13.25)
Week 52 (n =310, 310)	-3.0 (14.76)	-1.6 (12.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -1.9 to 1.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.93
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; -0.1 to 3.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.02
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; -1.0 to 3.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.03
	Estimation Comments	[Not Specified]

14. Secondary Outcome

Title	Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: percent change
Week 12 (n =330, 340)	5.9 (34.90)	-9.4 (42.00)
Week 24 (n =331, 336)	7.0 (37.79)	-13.8 (33.24)
Week 52 (n =313, 315)	0.6 (38.33)	-9.3 (48.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS-Mean Difference
	Estimated Value	-14.2
	Confidence Interval	(2-Sided) 95%; -19.9 to -8.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.88
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-19.9
	Confidence Interval	(2-Sided) 95%; -25.1 to -14.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.65
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-9.2
	Confidence Interval	(2-Sided) 95%; -15.7 to -2.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.31
	Estimation Comments	[Not Specified]

15. Secondary Outcome

Title	Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off
Description	Absolute change from baseline among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized.'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	353	357
Mean (Standard Deviation); Unit of Measure: mg/dL
TG <200 mg/dL: Baseline (n =282, 282)	111.2 (31.28)	112.8 (36.42)
TG <200 mg/dL: Change at Week12 (n =262, 266)	0.4 (22.60)	-63.4 (37.38)
TG >=200 mg/dL: Baseline (n =71, 75)	126.5 (42.07)	125.7 (42.10)
TG >=200 mg/dL: Change at Week 12 (n =67, 70)	-2.6 (26.98)	-63.1 (44.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	TG <200 mg/dL (Week 12): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-64.2
	Confidence Interval	(2-Sided) 95%; -69.1 to -59.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.51
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	TG >=200 mg/dL (Week 12): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-59.6
	Confidence Interval	(2-Sided) 95%; -71.4 to -47.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.99
	Estimation Comments	[Not Specified]

16. Secondary Outcome

Title	Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: mg/dL
Baseline (n =353, 357)	114.3 (34.22)	115.5 (37.99)
Change at Week 12 (n =329, 336)	-0.2 (23.55)	-63.3 (39.00)
Change at Week 24 (n =331, 336)	5.5 (33.14)	-56.0 (39.34)
Change at Week 52 (n =311, 313)	3.9 (32.17)	-45.9 (46.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-63.4
	Confidence Interval	(2-Sided) 95%; -68.0 to -58.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.35
	Estimation Comments	[Not Specified]

17. Secondary Outcome

Title	Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: mg/dL
Baseline (n =354, 357)	186.0 (40.04)	189.0 (44.68)
Change at Week 12 (n =330, 340)	0.6 (27.64)	-66.8 (42.38)
Change at Week 24 (n =331, 337)	5.1 (35.83)	-60.1 (43.33)
Change at Week 52 (n =313, 315)	1.8 (35.18)	-51.9 (49.68)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-67.1
	Confidence Interval	(2-Sided) 95%; -72.2 to -62.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.59
	Estimation Comments	[Not Specified]

18. Secondary Outcome

Title	Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: mg/dL
Baseline (n =354, 357)	137.2 (37.38)	140.1 (43.48)
Change at Week 12 (n =330, 339)	0.3 (26.53)	-69.8 (43.53)
Change at Week 24 (n =329, 336)	5.2 (35.91)	-63.6 (44.37)
Change at Week 52 (n =312, 314)	1.3 (33.93)	-53.9 (51.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-69.7
	Confidence Interval	(2-Sided) 95%; -74.7 to -64.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.57
	Estimation Comments	[Not Specified]

19. Secondary Outcome

Title	Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: mg/dL
Baseline (n =354, 357)	94.0 (21.51)	95.1 (25.57)
Change at Week 12 (n =330, 339)	-0.5 (17.32)	-47.9 (28.40)
Change at Week 24 (n =331, 335)	2.5 (19.87)	-43.9 (29.95)
Change at Week 52 (n =313, 313)	0.9 (20.59)	-36.4 (32.23)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-47.3
	Confidence Interval	(2-Sided) 95%; -50.7 to -43.8
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.74
	Estimation Comments	[Not Specified]

20. Secondary Outcome

Title	Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: mg/dL
Baseline (n =353, 356)	44.0 (45.93)	45.1 (52.30)
Change at Week 12 (n =330, 339)	-0.6 (10.42)	-11.4 (22.19)
Change at Week 24 (n =331, 336)	-1.2 (12.62)	-10.6 (20.16)
Change at Week 52 (n =311, 311)	-1.0 (10.71)	-8.6 (23.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-10.6
	Confidence Interval	(2-Sided) 95%; -12.9 to -8.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.17
	Estimation Comments	[Not Specified]

21. Secondary Outcome

Title	Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: mg/dL
Baseline (n =354, 357)	48.7 (12.52)	49.0 (13.23)
Change at Week 12 (n =330, 339)	0.4 (7.50)	2.9 (6.92)
Change at Week 24 (n =329, 336)	-0.0 (7.90)	3.3 (7.41)
Change at Week 52 (n =312, 314)	0.6 (7.59)	2.1 (8.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	2.4
	Confidence Interval	(2-Sided) 95%; 1.4 to 3.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.55
	Estimation Comments	[Not Specified]

22. Secondary Outcome

Title	Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: ratio
Baseline (n =354, 357)	4.0 (1.10)	4.1 (1.26)
Change at Week 12 (n =330, 339)	-0.0 (0.71)	-1.6 (1.17)
Change at Week 24 (n =329, 336)	0.1 (0.93)	-1.5 (1.21)
Change at Week 52 (n =312, 314)	0.0 (0.85)	-1.2 (1.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.6
	Confidence Interval	(2-Sided) 95%; -1.7 to -1.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.5
	Confidence Interval	(2-Sided) 95%; -1.7 to -1.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-1.2
	Confidence Interval	(2-Sided) 95%; -1.4 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.08
	Estimation Comments	[Not Specified]

23. Secondary Outcome

Title	Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: ratio
Baseline (n =354, 357)	0.7 (0.18)	0.7 (0.21)
Change at Week 12 (n =330, 339)	0.0 (0.12)	-0.3 (0.21)
Change at Week 24 (n =331, 335)	0.0 (0.16)	-0.3 (0.24)
Change at Week 52 (n =313, 313)	0.0 (0.14)	-0.3 (0.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -0.4 to -0.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.01
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -0.4 to -0.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.01
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -0.3 to -0.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.02
	Estimation Comments	[Not Specified]

24. Secondary Outcome

Title	Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Litre) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Week 12, 24 and 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Measure Type: Number; Unit of Measure: percentage of participants
Week 12 (n =330, 336)	41.5	87.5
Week 24 (n =332, 336)	37.3	82.1
Week 52 (n =312, 313)	36.9	77.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	24.0
	Confidence Interval	(2-Sided) 95%; 13.86 to 41.64
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 24
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	14.8
	Confidence Interval	(2-Sided) 95%; 9.32 to 23.56
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 52
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	9.8
	Confidence Interval	(2-Sided) 95%; 6.36 to 15.24
	Estimation Comments	[Not Specified]

25. Secondary Outcome

Title	Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Litre) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Week 12, 24 and 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Measure Type: Number; Unit of Measure: percentage of participants
Week 12 (n =330, 336)	5.5	76.8
Week 24 (n =332, 336)	3.3	69.6
Week 52 (n =312, 313)	6.4	61.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	95.2
	Confidence Interval	(2-Sided) 95%; 52.09 to 173.91
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 24
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	112.2
	Confidence Interval	(2-Sided) 95%; 55.81 to 225.52
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 150 mg
	Comments	Week 52
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	29.1
	Confidence Interval	(2-Sided) 95%; 17.13 to 49.49
	Estimation Comments	[Not Specified]

26. Secondary Outcome

Title	Plasma PF-04950615 Concentrations at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

Analysis set included participants who received at least 1 dose of PF-04950615. Here, 'n' signifies those participants who were evaluable at specified time points.

Arm/Group Title	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	356
Mean (Standard Deviation); Unit of Measure: microgram per milliliter
Week 12 (n =332)	5.53 (5.666)
Week 24 (n =327)	5.36 (6.029)
Week 52 (n =306)	4.07 (4.947)

27. Secondary Outcome

Title	Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
Description	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's, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, pain, pruritus and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.
Time Frame	Baseline up to the end of study (up to 58 weeks)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of study treatment.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	353	356
Measure Type: Number; Unit of Measure: participants
Type 1 or 3 hypersensitivity reactions	2	1
Injection site reactions	5	42

28. Secondary Outcome

Title	Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Description	Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer >=6.23 were considered to be ADA positive and participants with their nAb titer >=1.58 were considered to be nAb positive.
Time Frame	Baseline up to the end of study (up to 58 weeks)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of study treatment. Participants who received at least 1 dose of PF-04950615 were evaluable for this outcome measure. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	352
Measure Type: Number; Unit of Measure: percentage of participants
ADA	44
nAb	27

29. Other Pre-specified Outcome

Title	Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: mg/dL
Baseline (n =354, 357)	149.5 (66.83)	156.2 (78.75)
Change at Week 12 (n =330, 340)	3.8 (57.04)	-23.0 (71.52)
Change at Week 24 (n =331, 336)	5.0 (64.34)	-28.9 (68.41)
Change at Week 52 (n =313, 315)	-7.7 (64.14)	-24.3 (82.21)

30. Other Pre-specified Outcome

Title	Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: mg/dL
Baseline (n =354, 357)	147.5 (24.25)	147.2 (24.96)
Change at Week 12 (n =330, 339)	-1.2 (19.46)	4.6 (18.32)
Change at Week 24 (n =331, 336)	-2.3 (19.33)	5.6 (17.53)
Change at Week 52 (n =313, 313)	-0.2 (19.56)	3.8 (18.86)

31. Other Pre-specified Outcome

Title	Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52
Description	[Not Specified]
Time Frame	Baseline, Week 12, 24, 52

Outcome Measure Data

Analysis Population Description

FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description:	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
Overall Number of Participants Analyzed	354	357
Mean (Standard Deviation); Unit of Measure: mg/dL
Baseline (n =353, 356)	38.1 (6.46)	38.2 (6.58)
Change at Week 12 (n =327, 339)	-0.9 (4.95)	-0.9 (4.63)
Change at Week 24 (n =331, 335)	-1.7 (5.65)	-1.0 (5.07)
Change at Week 52 (n =310, 310)	-1.5 (5.54)	-0.9 (5.15)

Adverse Events

Time Frame	Baseline up to the end of study (up to 58 weeks)
Adverse Event Reporting Description	The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
Arm/Group Title	Placebo	PF-04950615 150 mg
Arm/Group Description	Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.	Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
All-Cause Mortality
	Placebo	PF-04950615 150 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Placebo	PF-04950615 150 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	40/353 (11.33%)	45/356 (12.64%)
Blood and lymphatic system disorders
Anaemia * 1	0/353 (0.00%)	1/356 (0.28%)
Normochromic normocytic anaemia * 1	1/353 (0.28%)	0/356 (0.00%)
Cardiac disorders
Acute coronary syndrome * 1	1/353 (0.28%)	0/356 (0.00%)
Angina pectoris * 1	2/353 (0.57%)	0/356 (0.00%)
Angina unstable * 1	1/353 (0.28%)	3/356 (0.84%)
Atrial fibrillation * 1	0/353 (0.00%)	1/356 (0.28%)
Bradycardia * 1	1/353 (0.28%)	1/356 (0.28%)
Cardiac failure * 1	1/353 (0.28%)	0/356 (0.00%)
Cardiac failure congestive * 1	2/353 (0.57%)	1/356 (0.28%)
Coronary artery disease * 1	2/353 (0.57%)	2/356 (0.56%)
Left ventricular failure * 1	0/353 (0.00%)	1/356 (0.28%)
Myocardial infarction * 1	3/353 (0.85%)	5/356 (1.40%)
Myocardial ischaemia * 1	1/353 (0.28%)	1/356 (0.28%)
Silent myocardial infarction * 1	0/353 (0.00%)	1/356 (0.28%)
Ventricular extrasystoles * 1	0/353 (0.00%)	1/356 (0.28%)
Eye disorders
Retinal aneurysm * 1	1/353 (0.28%)	0/356 (0.00%)
Retinal haemorrhage * 1	1/353 (0.28%)	0/356 (0.00%)
Gastrointestinal disorders
Faecaloma * 1	0/353 (0.00%)	1/356 (0.28%)
Gastritis * 1	1/353 (0.28%)	0/356 (0.00%)
Inguinal hernia * 1	0/353 (0.00%)	1/356 (0.28%)
Intestinal ischaemia * 1	1/353 (0.28%)	0/356 (0.00%)
Large intestine polyp * 1	1/353 (0.28%)	0/356 (0.00%)
Mesenteric artery stenosis * 1	1/353 (0.28%)	0/356 (0.00%)
Pancreatitis acute * 1	0/353 (0.00%)	1/356 (0.28%)
Small intestinal obstruction * 1	1/353 (0.28%)	0/356 (0.00%)
General disorders
Chest pain * 1	2/353 (0.57%)	4/356 (1.12%)
Non-cardiac chest pain * 1	3/353 (0.85%)	2/356 (0.56%)
Pyrexia * 1	0/353 (0.00%)	1/356 (0.28%)
Infections and infestations
Appendicitis * 1	1/353 (0.28%)	0/356 (0.00%)
Appendicitis perforated * 1	1/353 (0.28%)	0/356 (0.00%)
Arthritis bacterial * 1	1/353 (0.28%)	0/356 (0.00%)
Bursitis infective * 1	1/353 (0.28%)	0/356 (0.00%)
Cellulitis * 1	1/353 (0.28%)	2/356 (0.56%)
Diverticulitis * 1	1/353 (0.28%)	0/356 (0.00%)
Encephalitis * 1	1/353 (0.28%)	0/356 (0.00%)
Endocarditis staphylococcal * 1	0/353 (0.00%)	1/356 (0.28%)
Gastroenteritis * 1	1/353 (0.28%)	0/356 (0.00%)
Gastroenteritis viral * 1	0/353 (0.00%)	1/356 (0.28%)
Hepatitis B * 1	0/353 (0.00%)	1/356 (0.28%)
Pneumonia * 1	1/353 (0.28%)	1/356 (0.28%)
Sepsis * 1	1/353 (0.28%)	0/356 (0.00%)
Staphylococcal bacteraemia * 1	0/353 (0.00%)	1/356 (0.28%)
Urinary tract infection * 1	0/353 (0.00%)	1/356 (0.28%)
Urosepsis * 1	0/353 (0.00%)	1/356 (0.28%)
Injury, poisoning and procedural complications
Craniocerebral injury * 1	0/353 (0.00%)	1/356 (0.28%)
Fall * 1	0/353 (0.00%)	2/356 (0.56%)
Femur fracture * 1	1/353 (0.28%)	0/356 (0.00%)
Humerus fracture * 1	1/353 (0.28%)	1/356 (0.28%)
Lumbar vertebral fracture * 1	1/353 (0.28%)	1/356 (0.28%)
Patella fracture * 1	1/353 (0.28%)	0/356 (0.00%)
Pelvic fracture * 1	0/353 (0.00%)	1/356 (0.28%)
Subdural haematoma * 1	1/353 (0.28%)	1/356 (0.28%)
Vascular graft complication * 1	1/353 (0.28%)	0/356 (0.00%)
Wound * 1	0/353 (0.00%)	1/356 (0.28%)
Metabolism and nutrition disorders
Dehydration * 1	2/353 (0.57%)	0/356 (0.00%)
Hypoglycaemia * 1	0/353 (0.00%)	1/356 (0.28%)
Type 2 diabetes mellitus * 1	0/353 (0.00%)	1/356 (0.28%)
Musculoskeletal and connective tissue disorders
Bursitis * 1	0/353 (0.00%)	1/356 (0.28%)
Haemarthrosis * 1	0/353 (0.00%)	1/356 (0.28%)
Musculoskeletal chest pain * 1	1/353 (0.28%)	0/356 (0.00%)
Musculoskeletal pain * 1	0/353 (0.00%)	1/356 (0.28%)
Osteoarthritis * 1	1/353 (0.28%)	1/356 (0.28%)
Pain in extremity * 1	0/353 (0.00%)	1/356 (0.28%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer * 1	0/353 (0.00%)	2/356 (0.56%)
Invasive ductal breast carcinoma * 1	0/353 (0.00%)	1/356 (0.28%)
Lung neoplasm malignant * 1	2/353 (0.57%)	0/356 (0.00%)
Malignant melanoma of sites other than skin * 1	1/353 (0.28%)	0/356 (0.00%)
Metastases to central nervous system * 1	1/353 (0.28%)	0/356 (0.00%)
Prostate cancer * 1 [1]	1/224 (0.45%)	0/221 (0.00%)
Nervous system disorders
Intracranial aneurysm * 1	1/353 (0.28%)	0/356 (0.00%)
Lethargy * 1	0/353 (0.00%)	1/356 (0.28%)
Nerve root compression * 1	1/353 (0.28%)	0/356 (0.00%)
Presyncope * 1	0/353 (0.00%)	1/356 (0.28%)
Subarachnoid haemorrhage * 1	0/353 (0.00%)	1/356 (0.28%)
Syncope * 1	1/353 (0.28%)	1/356 (0.28%)
Transient ischaemic attack * 1	1/353 (0.28%)	0/356 (0.00%)
Psychiatric disorders
Completed suicide * 1	1/353 (0.28%)	0/356 (0.00%)
Suicidal behaviour * 1	0/353 (0.00%)	1/356 (0.28%)
Renal and urinary disorders
Acute kidney injury * 1	2/353 (0.57%)	0/356 (0.00%)
Respiratory, thoracic and mediastinal disorders
Asthma * 1	1/353 (0.28%)	0/356 (0.00%)
Dyspnoea * 1	1/353 (0.28%)	0/356 (0.00%)
Pulmonary embolism * 1	0/353 (0.00%)	1/356 (0.28%)
Skin and subcutaneous tissue disorders
Angioedema * 1	1/353 (0.28%)	0/356 (0.00%)
Psoriasis * 1	1/353 (0.28%)	0/356 (0.00%)
Vascular disorders
Aortic aneurysm rupture * 1	0/353 (0.00%)	1/356 (0.28%)
Aortic stenosis * 1	0/353 (0.00%)	1/356 (0.28%)
Orthostatic hypotension * 1	0/353 (0.00%)	1/356 (0.28%)
Peripheral arterial occlusive disease * 1	1/353 (0.28%)	0/356 (0.00%)
Peripheral vascular disorder * 1	1/353 (0.28%)	0/356 (0.00%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 18.1; [1] This is gender specific event. The number of participants evaluable for this event are 224 and 221.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	Placebo	PF-04950615 150 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	185/353 (52.41%)	205/356 (57.58%)
Cardiac disorders
Angina pectoris * 1	4/353 (1.13%)	5/356 (1.40%)
Palpitations * 1	2/353 (0.57%)	4/356 (1.12%)
Gastrointestinal disorders
Abdominal pain * 1	4/353 (1.13%)	4/356 (1.12%)
Constipation * 1	4/353 (1.13%)	8/356 (2.25%)
Diarrhoea * 1	6/353 (1.70%)	12/356 (3.37%)
Dyspepsia * 1	4/353 (1.13%)	1/356 (0.28%)
Gastrooesophageal reflux disease * 1	5/353 (1.42%)	3/356 (0.84%)
Nausea * 1	7/353 (1.98%)	7/356 (1.97%)
Vomiting * 1	5/353 (1.42%)	4/356 (1.12%)
General disorders
Chest pain * 1	4/353 (1.13%)	2/356 (0.56%)
Fatigue * 1	5/353 (1.42%)	7/356 (1.97%)
Injection site bruising * 1	2/353 (0.57%)	5/356 (1.40%)
Injection site erythema * 1	3/353 (0.85%)	9/356 (2.53%)
Injection site haemorrhage * 1	2/353 (0.57%)	4/356 (1.12%)
Injection site pain * 1	4/353 (1.13%)	6/356 (1.69%)
Injection site pruritus * 1	0/353 (0.00%)	4/356 (1.12%)
Injection site reaction * 1	5/353 (1.42%)	42/356 (11.80%)
Non-cardiac chest pain * 1	5/353 (1.42%)	1/356 (0.28%)
Pain * 1	5/353 (1.42%)	0/356 (0.00%)
Infections and infestations
Acute sinusitis * 1	3/353 (0.85%)	5/356 (1.40%)
Bronchitis * 1	14/353 (3.97%)	13/356 (3.65%)
Cellulitis * 1	4/353 (1.13%)	2/356 (0.56%)
Gastroenteritis * 1	8/353 (2.27%)	2/356 (0.56%)
Herpes zoster * 1	3/353 (0.85%)	4/356 (1.12%)
Influenza * 1	7/353 (1.98%)	10/356 (2.81%)
Nasopharyngitis * 1	27/353 (7.65%)	26/356 (7.30%)
Pharyngitis * 1	3/353 (0.85%)	6/356 (1.69%)
Pneumonia * 1	1/353 (0.28%)	8/356 (2.25%)
Rhinitis * 1	1/353 (0.28%)	4/356 (1.12%)
Sinusitis * 1	5/353 (1.42%)	10/356 (2.81%)
Upper respiratory tract infection * 1	19/353 (5.38%)	14/356 (3.93%)
Urinary tract infection * 1	6/353 (1.70%)	11/356 (3.09%)
Injury, poisoning and procedural complications
Contusion * 1	2/353 (0.57%)	4/356 (1.12%)
Fall * 1	13/353 (3.68%)	10/356 (2.81%)
Muscle strain * 1	1/353 (0.28%)	5/356 (1.40%)
Investigations
Alanine aminotransferase increased * 1	4/353 (1.13%)	0/356 (0.00%)
Blood cortisol decreased * 1	5/353 (1.42%)	6/356 (1.69%)
Blood creatine phosphokinase increased * 1	4/353 (1.13%)	3/356 (0.84%)
Gamma-glutamyltransferase increased * 1	6/353 (1.70%)	1/356 (0.28%)
Vitamin D decreased * 1	3/353 (0.85%)	5/356 (1.40%)
Metabolism and nutrition disorders
Diabetes mellitus * 1	3/353 (0.85%)	4/356 (1.12%)
Hypoglycaemia * 1	4/353 (1.13%)	5/356 (1.40%)
Type 2 diabetes mellitus * 1	5/353 (1.42%)	4/356 (1.12%)
Vitamin D deficiency * 1	36/353 (10.20%)	19/356 (5.34%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	7/353 (1.98%)	13/356 (3.65%)
Back pain * 1	8/353 (2.27%)	15/356 (4.21%)
Muscle spasms * 1	8/353 (2.27%)	4/356 (1.12%)
Musculoskeletal pain * 1	5/353 (1.42%)	7/356 (1.97%)
Myalgia * 1	9/353 (2.55%)	8/356 (2.25%)
Osteoarthritis * 1	3/353 (0.85%)	5/356 (1.40%)
Pain in extremity * 1	11/353 (3.12%)	5/356 (1.40%)
Tendonitis * 1	2/353 (0.57%)	4/356 (1.12%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma * 1	4/353 (1.13%)	1/356 (0.28%)
Nervous system disorders
Dizziness * 1	12/353 (3.40%)	1/356 (0.28%)
Headache * 1	14/353 (3.97%)	8/356 (2.25%)
Hypoaesthesia * 1	4/353 (1.13%)	1/356 (0.28%)
Psychiatric disorders
Anxiety * 1	5/353 (1.42%)	1/356 (0.28%)
Depression * 1	3/353 (0.85%)	6/356 (1.69%)
Reproductive system and breast disorders
Benign prostatic hyperplasia * 1 [1]	3/224 (1.34%)	1/221 (0.45%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease * 1	3/353 (0.85%)	6/356 (1.69%)
Cough * 1	9/353 (2.55%)	8/356 (2.25%)
Dyspnoea * 1	6/353 (1.70%)	3/356 (0.84%)
Sleep apnoea syndrome * 1	2/353 (0.57%)	4/356 (1.12%)
Skin and subcutaneous tissue disorders
Rash * 1	4/353 (1.13%)	3/356 (0.84%)
Vascular disorders
Hypertension * 1	11/353 (3.12%)	12/356 (3.37%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 18.1; [1] This is gender specific event. The number of participants evaluable for this event are 224 and 221.

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wang EQ, Bukowski JF, Yunis C, Shear CL, Ridker PM, Schwartz PF, Baltrukonis D. Assessing the Potential Risk of Cross-Reactivity Between Anti-Bococizumab Antibodies and Other Anti-PCSK9 Monoclonal Antibodies. BioDrugs. 2019 Oct;33(5):571-579. doi: 10.1007/s40259-019-00375-0.

Ridker PM, Rose LM, Kastelein JJP, Santos RD, Wei C, Revkin J, Yunis C, Tardif JC, Shear CL; Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Investigators. Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab. J Clin Lipidol. 2018 Jul - Aug;12(4):958-965. doi: 10.1016/j.jacl.2018.03.088. Epub 2018 Apr 3.

Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01968954
• Other Study ID Numbers: B1481019; 2013-002642-37 ( EudraCT Number ); SPIRE-HR ( Other Identifier: Alias Study Number )
• First Submitted: October 21, 2013
• First Posted: October 24, 2013
• Results First Submitted: April 6, 2017
• Results First Posted: May 17, 2017
• Last Update Posted: May 17, 2017