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

A Phase 3 Double-blind,Randomized, Placebo-controlled,Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01968954

Acronym

SPIRE-HR

Enrollment

711

Registered

2013-10-24

Start date

2013-10-31

Completion date

2016-04-30

Last updated

2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia

Keywords

mixed dyslipidemia, high risk of cardiovascular events

Brief summary

This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.

Interventions

DRUGBococizumab (PF-04950615;RN316)

150 mg every 2 weeks, subcutaneous injection, 12 months

OTHERPlacebo

subcutaneous injection, every 2 weeks for 12 months

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

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.

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 Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52	Baseline, Week 12, 24, 52	—
Plasma PF-04950615 Concentrations at Week 12, 24 and 52	Week 12, 24, 52	—
Number of Participants With Adverse Events (AEs) 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'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.
Percentage of Participants With 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. 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.
Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Baseline, Week 12, 24, 52	—
Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Baseline, Week 12, 24, 52	—
Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Baseline, Week 12, 24, 52	—
Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52	Baseline, Week 12, 24, 52	—
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Baseline, Week 12, 24, 52	—
Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia	Baseline, Week 12	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.
Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia	Baseline, Week 12	Participants with mixed dyslipidemia are defined as TG level greater than or equal to (\>=) 200 mg/dL (2.26 mmol/L) at pre-randomization.
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52	Baseline, Week 24, 52	—
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off	Baseline, Week 24, 52	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.
Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52	Baseline, Week 12, 24, 52	—
Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Baseline, Week 12, 24, 52	—
Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Baseline, Week 12, 24, 52	—
Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off	Baseline, Week 12	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.
Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52	Baseline, Week 12, 24, 52	—
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Baseline, Week 12, 24, 52	—
Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52	Baseline, Week 12, 24, 52	—
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Baseline, Week 12, 24, 52	—
Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Baseline, Week 12, 24, 52	—
Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Baseline, Week 12, 24, 52	—
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	Baseline, Week 12, 24, 52	—
Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52	Baseline, Week 12, 24, 52	—
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	Week 12, 24 and 52	—
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	Week 12, 24 and 52	—

Other

Measure	Time frame
Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Baseline, Week 12, 24, 52

Countries

Australia, Canada, Czechia, Germany, Hong Kong, Italy, Poland, South Korea, United States

Participant flow

Participants by arm

Arm	Count
Placebo 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.	354
PF-04950615 150 mg 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.	357
Total	711

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	6	3
Overall Study	Death	1	2
Overall Study	Did not met inclusion criteria	0	2
Overall Study	Lost to Follow-up	6	4
Overall Study	Other	7	8
Overall Study	Protocol Violation	0	1
Overall Study	Withdrawal by Subject	20	23

Baseline characteristics

Characteristic	Placebo	PF-04950615 150 mg	Total
Age, Continuous	61.5 years STANDARD_DEVIATION 9.7	61.1 years STANDARD_DEVIATION 10.2	61.3 years STANDARD_DEVIATION 10
Sex: Female, Male Female	130 Participants	136 Participants	266 Participants
Sex: Female, Male Male	224 Participants	221 Participants	445 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	185 / 353	205 / 356
serious Total, serious adverse events	40 / 353	45 / 356

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	1.0 percent change	Standard Deviation 20.89
PF-04950615 150 mg	Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12	-55.6 percent change	Standard Deviation 29.17

Comparison: 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.p-value: <0.00195% CI: [-61, -53.1]Mixed Model Repeated Measures (MMRM)

Secondary

Absolute Change From Baseline in Apolipoprotein B (ApoB) 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Change at Week 12 (n =330, 339)	-0.5 mg/dL	Standard Deviation 17.32
Placebo	Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Change at Week 24 (n =331, 335)	2.5 mg/dL	Standard Deviation 19.87
Placebo	Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Change at Week 52 (n =313, 313)	0.9 mg/dL	Standard Deviation 20.59
Placebo	Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Baseline (n =354, 357)	94.0 mg/dL	Standard Deviation 21.51
PF-04950615 150 mg	Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Baseline (n =354, 357)	95.1 mg/dL	Standard Deviation 25.57
PF-04950615 150 mg	Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Change at Week 12 (n =330, 339)	-47.9 mg/dL	Standard Deviation 28.4
PF-04950615 150 mg	Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Change at Week 52 (n =313, 313)	-36.4 mg/dL	Standard Deviation 32.23
PF-04950615 150 mg	Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Change at Week 24 (n =331, 335)	-43.9 mg/dL	Standard Deviation 29.95

Comparison: 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.95% CI: [-50.7, -43.8]

Secondary

Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52	Baseline (n =353, 357)	114.3 mg/dL	Standard Deviation 34.22
Placebo	Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52	Change at Week 12 (n =329, 336)	-0.2 mg/dL	Standard Deviation 23.55
Placebo	Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52	Change at Week 24 (n =331, 336)	5.5 mg/dL	Standard Deviation 33.14
Placebo	Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52	Change at Week 52 (n =311, 313)	3.9 mg/dL	Standard Deviation 32.17
PF-04950615 150 mg	Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52	Change at Week 52 (n =311, 313)	-45.9 mg/dL	Standard Deviation 46.43
PF-04950615 150 mg	Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52	Baseline (n =353, 357)	115.5 mg/dL	Standard Deviation 37.99
PF-04950615 150 mg	Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52	Change at Week 24 (n =331, 336)	-56.0 mg/dL	Standard Deviation 39.34
PF-04950615 150 mg	Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52	Change at Week 12 (n =329, 336)	-63.3 mg/dL	Standard Deviation 39

Secondary

Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off

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

Population: 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	Measure	Group	Value (MEAN)	Dispersion
Placebo	Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off	TG <200 mg/dL: Baseline (n =282, 282)	111.2 mg/dL	Standard Deviation 31.28
Placebo	Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off	TG <200 mg/dL: Change at Week12 (n =262, 266)	0.4 mg/dL	Standard Deviation 22.6
Placebo	Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off	TG >=200 mg/dL: Baseline (n =71, 75)	126.5 mg/dL	Standard Deviation 42.07
Placebo	Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off	TG >=200 mg/dL: Change at Week 12 (n =67, 70)	-2.6 mg/dL	Standard Deviation 26.98
PF-04950615 150 mg	Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off	TG >=200 mg/dL: Change at Week 12 (n =67, 70)	-63.1 mg/dL	Standard Deviation 44.91
PF-04950615 150 mg	Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off	TG <200 mg/dL: Baseline (n =282, 282)	112.8 mg/dL	Standard Deviation 36.42
PF-04950615 150 mg	Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off	TG >=200 mg/dL: Baseline (n =71, 75)	125.7 mg/dL	Standard Deviation 42.1
PF-04950615 150 mg	Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off	TG <200 mg/dL: Change at Week12 (n =262, 266)	-63.4 mg/dL	Standard Deviation 37.38

Comparison: 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.95% CI: [-69.1, -59.2]

Comparison: 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.95% CI: [-71.4, -47.7]

Secondary

Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Baseline (n =354, 357)	48.7 mg/dL	Standard Deviation 12.52
Placebo	Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Change at Week 12 (n =330, 339)	0.4 mg/dL	Standard Deviation 7.5
Placebo	Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Change at Week 24 (n =329, 336)	-0.0 mg/dL	Standard Deviation 7.9
Placebo	Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Change at Week 52 (n =312, 314)	0.6 mg/dL	Standard Deviation 7.59
PF-04950615 150 mg	Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Change at Week 52 (n =312, 314)	2.1 mg/dL	Standard Deviation 8.32
PF-04950615 150 mg	Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Baseline (n =354, 357)	49.0 mg/dL	Standard Deviation 13.23
PF-04950615 150 mg	Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Change at Week 24 (n =329, 336)	3.3 mg/dL	Standard Deviation 7.41
PF-04950615 150 mg	Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Change at Week 12 (n =330, 339)	2.9 mg/dL	Standard Deviation 6.92

Secondary

Absolute Change From Baseline in Lipoprotein(a) 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Baseline (n =353, 356)	44.0 mg/dL	Standard Deviation 45.93
Placebo	Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Change at Week 12 (n =330, 339)	-0.6 mg/dL	Standard Deviation 10.42
Placebo	Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Change at Week 24 (n =331, 336)	-1.2 mg/dL	Standard Deviation 12.62
Placebo	Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Change at Week 52 (n =311, 311)	-1.0 mg/dL	Standard Deviation 10.71
PF-04950615 150 mg	Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Change at Week 52 (n =311, 311)	-8.6 mg/dL	Standard Deviation 23.78
PF-04950615 150 mg	Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Baseline (n =353, 356)	45.1 mg/dL	Standard Deviation 52.3
PF-04950615 150 mg	Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Change at Week 24 (n =331, 336)	-10.6 mg/dL	Standard Deviation 20.16
PF-04950615 150 mg	Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Change at Week 12 (n =330, 339)	-11.4 mg/dL	Standard Deviation 22.19

Secondary

Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52	Baseline (n =354, 357)	137.2 mg/dL	Standard Deviation 37.38
Placebo	Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52	Change at Week 12 (n =330, 339)	0.3 mg/dL	Standard Deviation 26.53
Placebo	Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52	Change at Week 24 (n =329, 336)	5.2 mg/dL	Standard Deviation 35.91
Placebo	Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52	Change at Week 52 (n =312, 314)	1.3 mg/dL	Standard Deviation 33.93
PF-04950615 150 mg	Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52	Change at Week 52 (n =312, 314)	-53.9 mg/dL	Standard Deviation 51.1
PF-04950615 150 mg	Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52	Baseline (n =354, 357)	140.1 mg/dL	Standard Deviation 43.48
PF-04950615 150 mg	Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52	Change at Week 24 (n =329, 336)	-63.6 mg/dL	Standard Deviation 44.37
PF-04950615 150 mg	Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52	Change at Week 12 (n =330, 339)	-69.8 mg/dL	Standard Deviation 43.53

Secondary

Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52	Baseline (n =354, 357)	0.7 ratio	Standard Deviation 0.18
Placebo	Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52	Change at Week 12 (n =330, 339)	0.0 ratio	Standard Deviation 0.12
Placebo	Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52	Change at Week 24 (n =331, 335)	0.0 ratio	Standard Deviation 0.16
Placebo	Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52	Change at Week 52 (n =313, 313)	0.0 ratio	Standard Deviation 0.14
PF-04950615 150 mg	Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52	Change at Week 52 (n =313, 313)	-0.3 ratio	Standard Deviation 0.25
PF-04950615 150 mg	Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52	Baseline (n =354, 357)	0.7 ratio	Standard Deviation 0.21
PF-04950615 150 mg	Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52	Change at Week 24 (n =331, 335)	-0.3 ratio	Standard Deviation 0.24
PF-04950615 150 mg	Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52	Change at Week 12 (n =330, 339)	-0.3 ratio	Standard Deviation 0.21

Comparison: 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.95% CI: [-0.4, -0.3]

Comparison: 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.95% CI: [-0.3, -0.2]

Secondary

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

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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	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	Baseline (n =354, 357)	4.0 ratio	Standard Deviation 1.1
Placebo	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	Change at Week 12 (n =330, 339)	-0.0 ratio	Standard Deviation 0.71
Placebo	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	Change at Week 24 (n =329, 336)	0.1 ratio	Standard Deviation 0.93
Placebo	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	Change at Week 52 (n =312, 314)	0.0 ratio	Standard Deviation 0.85
PF-04950615 150 mg	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	Change at Week 52 (n =312, 314)	-1.2 ratio	Standard Deviation 1.35
PF-04950615 150 mg	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	Baseline (n =354, 357)	4.1 ratio	Standard Deviation 1.26
PF-04950615 150 mg	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	Change at Week 24 (n =329, 336)	-1.5 ratio	Standard Deviation 1.21
PF-04950615 150 mg	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	Change at Week 12 (n =330, 339)	-1.6 ratio	Standard Deviation 1.17

Secondary

Absolute Change From Baseline in Total Cholesterol (TC) 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Change at Week 52 (n =313, 315)	1.8 mg/dL	Standard Deviation 35.18
Placebo	Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Baseline (n =354, 357)	186.0 mg/dL	Standard Deviation 40.04
Placebo	Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Change at Week 12 (n =330, 340)	0.6 mg/dL	Standard Deviation 27.64
Placebo	Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Change at Week 24 (n =331, 337)	5.1 mg/dL	Standard Deviation 35.83
PF-04950615 150 mg	Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Change at Week 24 (n =331, 337)	-60.1 mg/dL	Standard Deviation 43.33
PF-04950615 150 mg	Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Change at Week 52 (n =313, 315)	-51.9 mg/dL	Standard Deviation 49.68
PF-04950615 150 mg	Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Change at Week 12 (n =330, 340)	-66.8 mg/dL	Standard Deviation 42.38
PF-04950615 150 mg	Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Baseline (n =354, 357)	189.0 mg/dL	Standard Deviation 44.68

Secondary

Number of Participants With Adverse Events (AEs) 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'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)

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 (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions	Type 1 or 3 hypersensitivity reactions	2 participants
Placebo	Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions	Injection site reactions	5 participants
PF-04950615 150 mg	Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions	Injection site reactions	42 participants
PF-04950615 150 mg	Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions	Type 1 or 3 hypersensitivity reactions	1 participants

Secondary

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

Time frame: Week 12, 24 and 52

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

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Litre) at Week 12, 24 and 52	Week 12 (n =330, 336)	41.5 percentage of participants
Placebo	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	Week 24 (n =332, 336)	37.3 percentage of participants
Placebo	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	Week 52 (n =312, 313)	36.9 percentage of participants
PF-04950615 150 mg	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	Week 12 (n =330, 336)	87.5 percentage of participants
PF-04950615 150 mg	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	Week 24 (n =332, 336)	82.1 percentage of participants
PF-04950615 150 mg	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	Week 52 (n =312, 313)	77.3 percentage of participants

Comparison: Week 1295% CI: [13.86, 41.64]

Comparison: Week 2495% CI: [9.32, 23.56]

Comparison: Week 5295% CI: [6.36, 15.24]

Secondary

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

Time frame: Week 12, 24 and 52

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

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Litre) at Week 12, 24 and 52	Week 12 (n =330, 336)	5.5 percentage of participants
Placebo	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	Week 24 (n =332, 336)	3.3 percentage of participants
Placebo	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	Week 52 (n =312, 313)	6.4 percentage of participants
PF-04950615 150 mg	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	Week 12 (n =330, 336)	76.8 percentage of participants
PF-04950615 150 mg	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	Week 24 (n =332, 336)	69.6 percentage of participants
PF-04950615 150 mg	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	Week 52 (n =312, 313)	61.7 percentage of participants

Comparison: Week 1295% CI: [52.09, 173.91]

Comparison: Week 2495% CI: [55.81, 225.52]

Comparison: Week 5295% CI: [17.13, 49.49]

Secondary

Percentage of Participants With 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. 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)

Population: 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	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)	ADA	44 percentage of participants
Placebo	Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)	nAb	27 percentage of participants

Secondary

Percent Change From Baseline in ApolipoproteinA-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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Week 12 (n =330, 339)	-0.3 percent change	Standard Deviation 14.05
Placebo	Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Week 24 (n =331, 336)	-0.8 percent change	Standard Deviation 12.77
Placebo	Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Week 52 (n =313, 313)	0.4 percent change	Standard Deviation 13.13
PF-04950615 150 mg	Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Week 12 (n =330, 339)	3.7 percent change	Standard Deviation 12.56
PF-04950615 150 mg	Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Week 24 (n =331, 336)	4.3 percent change	Standard Deviation 12.25
PF-04950615 150 mg	Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Week 52 (n =313, 313)	3.3 percent change	Standard Deviation 13

Secondary

Percent Change From Baseline in ApolipoproteinA-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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Week 12 (n =327, 339)	-1.8 percent change	Standard Deviation 12.92
Placebo	Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Week 24 (n =331, 335)	-3.7 percent change	Standard Deviation 14.4
Placebo	Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Week 52 (n =310, 310)	-3.0 percent change	Standard Deviation 14.76
PF-04950615 150 mg	Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Week 12 (n =327, 339)	-1.9 percent change	Standard Deviation 12.1
PF-04950615 150 mg	Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Week 24 (n =331, 335)	-1.9 percent change	Standard Deviation 13.25
PF-04950615 150 mg	Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Week 52 (n =310, 310)	-1.6 percent change	Standard Deviation 12.91

Secondary

Percent Change From Baseline in Apolipoprotein B (ApoB) 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Week 24 (n =331, 335)	3.5 percent change	Standard Deviation 22.39
Placebo	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Week 52 (n =313, 313)	1.9 percent change	Standard Deviation 22.25
Placebo	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Week 12 (n =330, 339)	0.3 percent change	Standard Deviation 19.1
PF-04950615 150 mg	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Week 12 (n =330, 339)	-51.1 percent change	Standard Deviation 27.62
PF-04950615 150 mg	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Week 24 (n =331, 335)	-47.3 percent change	Standard Deviation 30.43
PF-04950615 150 mg	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Week 52 (n =313, 313)	-39.1 percent change	Standard Deviation 33.39

Comparison: 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.p-value: <0.00195% CI: [-55.1, -47.9]MMRM

Secondary

Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia

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

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 Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia	-1.0 percent change	Standard Deviation 20.95
PF-04950615 150 mg	Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia	-50.9 percent change	Standard Deviation 33.78

Secondary

Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia

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

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 Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia	1.5 percent change	Standard Deviation 20.89
PF-04950615 150 mg	Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia	-56.8 percent change	Standard Deviation 27.78

Secondary

Percent Change From Baseline in Fasting 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52	Week 24 (n =331, 336)	6.3 percent change	Standard Deviation 32.52
Placebo	Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52	Week 52 (n =311, 313)	5.2 percent change	Standard Deviation 29.69
PF-04950615 150 mg	Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52	Week 24 (n =331, 336)	-50.0 percent change	Standard Deviation 31.36
PF-04950615 150 mg	Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52	Week 52 (n =311, 313)	-40.9 percent change	Standard Deviation 38.02

Secondary

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off

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

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off	TG <200 mg/dL: Week 24 (n =261, 265)	7.2 percent change	Standard Deviation 34.38
Placebo	Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off	TG <200 mg/dL: Week 52(n =243, 248)	6.2 percent change	Standard Deviation 29.95
Placebo	Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off	TG >=200 mg/dL: Week 24(n =70, 71)	3.0 percent change	Standard Deviation 24.3
Placebo	Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off	TG >=200 mg/dL: Week 52(n =68, 65)	2.0 percent change	Standard Deviation 28.74
PF-04950615 150 mg	Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off	TG >=200 mg/dL: Week 52(n =68, 65)	-40.1 percent change	Standard Deviation 37.01
PF-04950615 150 mg	Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off	TG <200 mg/dL: Week 24 (n =261, 265)	-50.8 percent change	Standard Deviation 30.9
PF-04950615 150 mg	Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off	TG >=200 mg/dL: Week 24(n =70, 71)	-46.9 percent change	Standard Deviation 33.05
PF-04950615 150 mg	Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off	TG <200 mg/dL: Week 52(n =243, 248)	-41.1 percent change	Standard Deviation 38.35

Comparison: 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.95% CI: [-63.1, -52]

Comparison: 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.95% CI: [-53.9, -41.5]

Comparison: 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.95% CI: [-58.9, -39.8]

Comparison: 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.95% CI: [-52.2, -30.1]

Secondary

Percent Change From Baseline in Fasting Triglyceride (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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52	Week 12 (n =330, 340)	5.9 percent change	Standard Deviation 34.9
Placebo	Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52	Week 24 (n =331, 336)	7.0 percent change	Standard Deviation 37.79
Placebo	Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52	Week 52 (n =313, 315)	0.6 percent change	Standard Deviation 38.33
PF-04950615 150 mg	Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52	Week 12 (n =330, 340)	-9.4 percent change	Standard Deviation 42
PF-04950615 150 mg	Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52	Week 24 (n =331, 336)	-13.8 percent change	Standard Deviation 33.24
PF-04950615 150 mg	Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52	Week 52 (n =313, 315)	-9.3 percent change	Standard Deviation 48.47

Secondary

Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Week 12 (n= 330, 339)	1.9 percent change	Standard Deviation 17.24
Placebo	Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Week 24 (n =329, 336)	1.0 percent change	Standard Deviation 15.78
Placebo	Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Week 52 (n =312, 314)	2.0 percent change	Standard Deviation 15.73
PF-04950615 150 mg	Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Week 12 (n= 330, 339)	6.6 percent change	Standard Deviation 14.24
PF-04950615 150 mg	Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Week 24 (n =329, 336)	7.8 percent change	Standard Deviation 15.91
PF-04950615 150 mg	Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Week 52 (n =312, 314)	5.3 percent change	Standard Deviation 16.59

Secondary

Percent Change From Baseline in Lipoprotein(a) 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Week 12 (n =330, 339)	4.7 percent change	Standard Deviation 84.86
Placebo	Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Week 24 (n =331, 336)	1.9 percent change	Standard Deviation 51.82
Placebo	Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Week 52 (n =311, 311)	1.1 percent change	Standard Deviation 42.47
PF-04950615 150 mg	Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Week 12 (n =330, 339)	1.9 percent change	Standard Deviation 508.44
PF-04950615 150 mg	Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Week 24 (n =331, 336)	4.4 percent change	Standard Deviation 465.24
PF-04950615 150 mg	Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Week 52 (n =311, 311)	17.3 percent change	Standard Deviation 562.63

Secondary

Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52	Week 12 (n =330, 339)	1.3 percent change	Standard Deviation 19.53
Placebo	Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52	Week 24 (n =329, 336)	4.7 percent change	Standard Deviation 27.81
Placebo	Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52	Week 52 (n =312, 314)	2.3 percent change	Standard Deviation 25.22
PF-04950615 150 mg	Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52	Week 12 (n =330, 339)	-50.0 percent change	Standard Deviation 26.28
PF-04950615 150 mg	Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52	Week 24 (n =329, 336)	-46.2 percent change	Standard Deviation 28.52
PF-04950615 150 mg	Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52	Week 52 (n =312, 314)	-38.9 percent change	Standard Deviation 33.32

Comparison: 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.95% CI: [-45.8, -36.5]

Secondary

Percent Change From Baseline in Total Cholesterol (TC) 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Week 12 (n =330, 340)	1.0 percent change	Standard Deviation 14.85
Placebo	Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Week 24 (n =331, 337)	3.2 percent change	Standard Deviation 19.35
Placebo	Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Week 52 (n =313, 315)	1.8 percent change	Standard Deviation 18.5
PF-04950615 150 mg	Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Week 12 (n =330, 340)	-35.1 percent change	Standard Deviation 19.23
PF-04950615 150 mg	Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Week 24 (n =331, 337)	-31.7 percent change	Standard Deviation 20.47
PF-04950615 150 mg	Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Week 52 (n =313, 315)	-27.3 percent change	Standard Deviation 23.57

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.

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 =330, 340)	5.9 percent change	Standard Deviation 34.9
Placebo	Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52	Week 24 (n =331, 336)	7.0 percent change	Standard Deviation 37.79
Placebo	Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52	Week 52 (n =313, 315)	0.6 percent change	Standard Deviation 38.33
PF-04950615 150 mg	Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52	Week 12 (n =330, 340)	-9.4 percent change	Standard Deviation 42
PF-04950615 150 mg	Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52	Week 24 (n =331, 336)	-13.8 percent change	Standard Deviation 33.24
PF-04950615 150 mg	Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52	Week 52 (n =313, 315)	-9.3 percent change	Standard Deviation 48.47

Secondary

Plasma PF-04950615 Concentrations at Week 12, 24 and 52

Time frame: Week 12, 24, 52

Population: 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	Measure	Group	Value (MEAN)	Dispersion
Placebo	Plasma PF-04950615 Concentrations at Week 12, 24 and 52	Week 12 (n =332)	5.53 microgram per milliliter	Standard Deviation 5.666
Placebo	Plasma PF-04950615 Concentrations at Week 12, 24 and 52	Week 24 (n =327)	5.36 microgram per milliliter	Standard Deviation 6.029
Placebo	Plasma PF-04950615 Concentrations at Week 12, 24 and 52	Week 52 (n =306)	4.07 microgram per milliliter	Standard Deviation 4.947

Other Pre-specified

Absolute Change From Baseline in ApolipoproteinA-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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Baseline (n =354, 357)	147.5 mg/dL	Standard Deviation 24.25
Placebo	Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Change at Week 12 (n =330, 339)	-1.2 mg/dL	Standard Deviation 19.46
Placebo	Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Change at Week 24 (n =331, 336)	-2.3 mg/dL	Standard Deviation 19.33
Placebo	Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Change at Week 52 (n =313, 313)	-0.2 mg/dL	Standard Deviation 19.56
PF-04950615 150 mg	Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Change at Week 52 (n =313, 313)	3.8 mg/dL	Standard Deviation 18.86
PF-04950615 150 mg	Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Baseline (n =354, 357)	147.2 mg/dL	Standard Deviation 24.96
PF-04950615 150 mg	Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Change at Week 24 (n =331, 336)	5.6 mg/dL	Standard Deviation 17.53
PF-04950615 150 mg	Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Change at Week 12 (n =330, 339)	4.6 mg/dL	Standard Deviation 18.32

Other Pre-specified

Absolute Change From Baseline in ApolipoproteinA-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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Baseline (n =353, 356)	38.1 mg/dL	Standard Deviation 6.46
Placebo	Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Change at Week 12 (n =327, 339)	-0.9 mg/dL	Standard Deviation 4.95
Placebo	Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Change at Week 24 (n =331, 335)	-1.7 mg/dL	Standard Deviation 5.65
Placebo	Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Change at Week 52 (n =310, 310)	-1.5 mg/dL	Standard Deviation 5.54
PF-04950615 150 mg	Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Change at Week 52 (n =310, 310)	-0.9 mg/dL	Standard Deviation 5.15
PF-04950615 150 mg	Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Baseline (n =353, 356)	38.2 mg/dL	Standard Deviation 6.58
PF-04950615 150 mg	Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Change at Week 24 (n =331, 335)	-1.0 mg/dL	Standard Deviation 5.07
PF-04950615 150 mg	Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Change at Week 12 (n =327, 339)	-0.9 mg/dL	Standard Deviation 4.63

Other Pre-specified

Absolute Change From Baseline in Triglyceride (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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52	Change at Week 12 (n =330, 340)	3.8 mg/dL	Standard Deviation 57.04
Placebo	Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52	Change at Week 52 (n =313, 315)	-7.7 mg/dL	Standard Deviation 64.14
Placebo	Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52	Change at Week 24 (n =331, 336)	5.0 mg/dL	Standard Deviation 64.34
Placebo	Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52	Baseline (n =354, 357)	149.5 mg/dL	Standard Deviation 66.83
PF-04950615 150 mg	Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52	Change at Week 12 (n =330, 340)	-23.0 mg/dL	Standard Deviation 71.52
PF-04950615 150 mg	Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52	Baseline (n =354, 357)	156.2 mg/dL	Standard Deviation 78.75
PF-04950615 150 mg	Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52	Change at Week 24 (n =331, 336)	-28.9 mg/dL	Standard Deviation 68.41
PF-04950615 150 mg	Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52	Change at Week 52 (n =313, 315)	-24.3 mg/dL	Standard Deviation 82.21

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026

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

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Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12

Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52

Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52

Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off

Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52

Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52

Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52

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

Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions

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

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

Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)

Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52

Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52

Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52

Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia

Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia

Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off

Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52

Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52

Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52

Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52

Plasma PF-04950615 Concentrations at Week 12, 24 and 52

Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52

Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52

Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52