Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin

A Phase 2b Double-blind, Randomized, Placebo-controlled, Parallel Group, Dose-ranging Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Monthly And Twice Monthly Subcutaneous Dosing For Six Months In Hypercholesterolemic Subjects On A Statin

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01592240

Enrollment

354

Registered

2012-05-07

Start date

2012-07-31

Completion date

2013-05-31

Last updated

2017-12-05

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

Conditions

Hypercholesterolemia

Keywords

PF-04950615, RN316

Brief summary

To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose LDL-cholesterol is \>/=80 mg/dL on background treatment with a statin.

Interventions

DRUGPBO

Placebo Q28d

DRUG200mg PF-04950615 (RN316)

PF-04950615 200 mg, Q28d

DRUG300mg PF-04950615 (RN316)

PF-04950615 300 mg, Q28d

DRUGPF-04950615

PF-04950615 50mg, Q14d

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects should be receiving a stable dose (at least 6 weeks) of any statin and continue on same dose of statin for the duration of this trial. * Lipids should meet the following criteria on a background treatment with a statin at 2 screening visits that occur at screening and at least 7 days prior to randomization on Day 1: * Fasting LDL-C greater than or equal to 80 mg/dL (2.31 mmol/L); * Fasting TG less than or equal to 400 mg/dL (4.52 mmol/L). * Subject's fasting LDL-cholesterol must greater than or equal to 80 mg/dL (2.31 mmol/L at the initial screening visit, and the value at the second visit within 7 days of randomization must be not lower than 20% of this initial value to meet eligibility criterion for this trial.

Exclusion criteria

* Participation in other studies within 3 months before the current study begins and/or during study participation. * Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. * Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 63 days after last dose of investigational product. * History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past 6 months. Congestive heart failure (CHF), NYHA functional classes III or IV. * Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c \>9%). * Poorly controlled hypertension.

Design outcomes

Primary

Measure	Time frame
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12	Baseline, Week 12

Secondary

Measure	Time frame	Description
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24	Baseline, Week 24	—
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24	Baseline, Week 12, 24	—
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Baseline, Week 12, 24	—
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Baseline, Week 12, 24	—
Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Baseline, Week 12, 24	—
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Baseline, Week 12, 24	—
Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Baseline, Week 12, 24	—
Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Baseline, Week 12, 24	—
Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Baseline, Week 12, 24	—
Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Baseline, Week 12, 24	—
Change From Baseline in Total Cholesterol at Week 12 and 24	Baseline, Week 12, 24	—
Percent Change From Baseline in Total Cholesterol at Week 12 and 24	Baseline, Week 12, 24	—
Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Baseline, Week 12, 24	—
Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Baseline, Week 12, 24	—
Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Baseline, Week 12, 24	—
Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Baseline, Week 12, 24	—
Change From Baseline in Triglycerides at Week 12 and 24	Baseline, Week 12, 24	—
Percent Change From Baseline in Triglycerides at Week 12 and 24	Baseline, Week 12, 24	—
Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Baseline, Week 12, 24	—
Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Baseline, Week 12, 24	—
Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)	Baseline up to Day 211 for every 28 days groups and Baseline up to Day 225 for every 14 days groups	Participants with titer value greater than or equal to 4.32 nanogram per milliliter were considered positive.
Percentage of Participants With Injection Site Adverse Events	Baseline up to Day 211 for 28 days groups and Baseline up to Day 225 for 14 days groups	Injection site adverse events included injection site bruising, discomfort, erythema, hemorrhage, induration, inflammation, pain, paresthesia, pruritus, swelling, urticaria, reaction and rash.
Plasma Concentration of PF-04950615 at Week 12 and 24	Week 12, 24	—
Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12, 24	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Placebo: Every 14 Days Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.	50
PF-04950615 50 mg: Every 14 Days Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.	50
PF-04950615 100 mg: Every 14 Days Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.	52
PF-04950615 150 mg: Every 14 Days Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.	50
Placebo: Every 28 Days Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.	51
PF-04950615 200 mg: Every 28 Days Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.	50
PF-04950615 300 mg: Every 28 Days Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.	51
Total	354

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006
Overall Study	Adverse Event	1	0	0	1	1	0	0
Overall Study	Death	0	1	0	0	0	0	0
Overall Study	Did Not Meet Entrance Criteria	1	0	1	0	0	0	0
Overall Study	Lost to Follow-up	1	3	1	0	3	2	0
Overall Study	Other	0	3	1	1	0	0	1
Overall Study	Protocol Violation	0	0	0	0	0	1	0
Overall Study	Withdrawal by Subject	0	4	4	1	3	0	2

Baseline characteristics

Characteristic	Placebo: Every 14 Days	PF-04950615 50 mg: Every 14 Days	PF-04950615 100 mg: Every 14 Days	PF-04950615 150 mg: Every 14 Days	Placebo: Every 28 Days	PF-04950615 200 mg: Every 28 Days	PF-04950615 300 mg: Every 28 Days	Total
Age, Continuous	60.5 Years STANDARD_DEVIATION 9.84	59.1 Years STANDARD_DEVIATION 11.26	61.9 Years STANDARD_DEVIATION 9.58	61.4 Years STANDARD_DEVIATION 9.75	58.4 Years STANDARD_DEVIATION 11.62	60.3 Years STANDARD_DEVIATION 9.64	60.2 Years STANDARD_DEVIATION 8.17	60.3 Years STANDARD_DEVIATION 10.01
Sex: Female, Male Female	25 Participants	26 Participants	26 Participants	29 Participants	22 Participants	31 Participants	26 Participants	185 Participants
Sex: Female, Male Male	25 Participants	24 Participants	26 Participants	21 Participants	29 Participants	19 Participants	25 Participants	169 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	35 / 49	27 / 50	38 / 51	35 / 49	28 / 51	32 / 50	25 / 51
serious Total, serious adverse events	7 / 49	4 / 50	2 / 51	4 / 49	2 / 51	5 / 50	4 / 51

Outcome results

Primary

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

Time frame: Baseline, Week 12

Population: Full analysis set included all participants who were randomized. Here Overall Number of Participants Analyzed, signifies number of participants those who were evaluable for this outcome measure.

Arm	Measure	Value (MEAN)
Placebo: Every 14 Days	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12	-2.6 milligram per deciliter (mg/dL)
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12	-36.9 milligram per deciliter (mg/dL)
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12	-47.6 milligram per deciliter (mg/dL)
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12	-56.0 milligram per deciliter (mg/dL)
Placebo: Every 28 Days	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12	4.6 milligram per deciliter (mg/dL)
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12	-23.0 milligram per deciliter (mg/dL)
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12	-40.3 milligram per deciliter (mg/dL)

p-value: <0.00195% CI: [-45.06, -23.5]Mixed models repeated measures analysis

p-value: <0.00195% CI: [-55.93, -34.21]Mixed models repeated measures analysis

p-value: <0.00195% CI: [-64.14, -42.7]Mixed models repeated measures analysis

p-value: <0.00195% CI: [-40.49, -14.67]Mixed models repeated measures analysis

p-value: <0.00195% CI: [-57.65, -32.05]Mixed models repeated measures analysis

Secondary

Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)
Placebo: Every 14 Days	Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Change at Week 12	2.1 milligram per deciliter
Placebo: Every 14 Days	Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Change at Week 24	0.8 milligram per deciliter
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Change at Week 12	3.9 milligram per deciliter
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Change at Week 24	1.4 milligram per deciliter
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Change at Week 12	7.6 milligram per deciliter
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Change at Week 24	1.2 milligram per deciliter
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Change at Week 12	6.0 milligram per deciliter
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Change at Week 24	4.9 milligram per deciliter
Placebo: Every 28 Days	Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Change at Week 12	2.2 milligram per deciliter
Placebo: Every 28 Days	Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Change at Week 24	2.0 milligram per deciliter
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Change at Week 12	7.8 milligram per deciliter
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Change at Week 24	0.6 milligram per deciliter
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Change at Week 12	6.6 milligram per deciliter
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Change at Week 24	-0.2 milligram per deciliter

Comparison: Week 12p-value: 0.66795% CI: [-6.33, 9.88]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.18795% CI: [-2.66, 13.54]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.35295% CI: [-4.25, 11.9]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.0995% CI: [-0.89, 12.09]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.18495% CI: [-2.1, 10.82]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.87995% CI: [-7.09, 8.28]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.91195% CI: [-7.17, 8.02]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.28395% CI: [-3.44, 11.69]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.72895% CI: [-9.41, 6.59]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.58795% CI: [-10.13, 5.75]Mixed models repeated measures analysis

Secondary

Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)
Placebo: Every 14 Days	Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Change at Week 12	1.0 milligram per deciliter
Placebo: Every 14 Days	Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Change at Week 24	-0.8 milligram per deciliter
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Change at Week 12	1.2 milligram per deciliter
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Change at Week 24	0.9 milligram per deciliter
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Change at Week 12	2.3 milligram per deciliter
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Change at Week 24	0.1 milligram per deciliter
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Change at Week 12	0.3 milligram per deciliter
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Change at Week 24	0.3 milligram per deciliter
Placebo: Every 28 Days	Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Change at Week 12	1.7 milligram per deciliter
Placebo: Every 28 Days	Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Change at Week 24	-0.1 milligram per deciliter
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Change at Week 12	1.2 milligram per deciliter
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Change at Week 24	-0.8 milligram per deciliter
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Change at Week 12	2.1 milligram per deciliter
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Change at Week 24	-0.5 milligram per deciliter

Comparison: Week 12p-value: 0.89395% CI: [-2.62, 3]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.35595% CI: [-1.49, 4.15]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.65595% CI: [-3.45, 2.17]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.71995% CI: [-3.2, 2.21]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.76895% CI: [-2.31, 3.12]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.19995% CI: [-0.88, 4.2]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.48395% CI: [-1.62, 3.41]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.4295% CI: [-1.49, 3.56]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.48895% CI: [-2.67, 1.28]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.69495% CI: [-2.36, 1.58]Mixed models repeated measures analysis

Secondary

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

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)
Placebo: Every 14 Days	Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Change at Week 12	-2.8 milligram per deciliter
Placebo: Every 14 Days	Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Change at Week 24	-2.5 milligram per deciliter
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Change at Week 12	-21.4 milligram per deciliter
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Change at Week 24	-22.2 milligram per deciliter
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Change at Week 12	-30.5 milligram per deciliter
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Change at Week 24	-30.7 milligram per deciliter
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Change at Week 12	-34.9 milligram per deciliter
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Change at Week 24	-27.9 milligram per deciliter
Placebo: Every 28 Days	Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Change at Week 12	2.3 milligram per deciliter
Placebo: Every 28 Days	Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Change at Week 24	-2.9 milligram per deciliter
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Change at Week 12	-12.2 milligram per deciliter
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Change at Week 24	-15.7 milligram per deciliter
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Change at Week 12	-26.2 milligram per deciliter
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Change at Week 24	-19.8 milligram per deciliter

Comparison: Week 12p-value: <0.00195% CI: [-25.44, -11.67]Mixed models repeated measures analysis

Comparison: Week 12p-value: <0.00195% CI: [-34.55, -20.79]Mixed models repeated measures analysis

Comparison: Week 12p-value: <0.00195% CI: [-38.95, -25.22]Mixed models repeated measures analysis

Comparison: Week 12p-value: <0.00195% CI: [-22.89, -6.24]Mixed models repeated measures analysis

Comparison: Week 12p-value: <0.00195% CI: [-36.83, -20.16]Mixed models repeated measures analysis

Comparison: Week 24p-value: <0.00195% CI: [-27.07, -12.27]Mixed models repeated measures analysis

Comparison: Week 24p-value: <0.00195% CI: [-35.52, -20.82]Mixed models repeated measures analysis

Comparison: Week 24p-value: <0.00195% CI: [-32.73, -18.09]Mixed models repeated measures analysis

Comparison: Week 24p-value: <0.00195% CI: [-19.35, -6.09]Mixed models repeated measures analysis

Comparison: Week 24p-value: <0.00195% CI: [-23.47, -10.23]Mixed models repeated measures analysis

Secondary

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

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)
Placebo: Every 14 Days	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Change at Week 12	0.3 milligram per deciliter
Placebo: Every 14 Days	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Change at Week 24	-0.2 milligram per deciliter
PF-04950615 50 mg: Every 14 Days	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Change at Week 12	1.9 milligram per deciliter
PF-04950615 50 mg: Every 14 Days	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Change at Week 24	1.6 milligram per deciliter
PF-04950615 100 mg: Every 14 Days	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Change at Week 12	2.0 milligram per deciliter
PF-04950615 100 mg: Every 14 Days	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Change at Week 24	0.6 milligram per deciliter
PF-04950615 150 mg: Every 14 Days	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Change at Week 12	0.8 milligram per deciliter
PF-04950615 150 mg: Every 14 Days	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Change at Week 24	0.3 milligram per deciliter
Placebo: Every 28 Days	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Change at Week 12	-1.0 milligram per deciliter
Placebo: Every 28 Days	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Change at Week 24	0.2 milligram per deciliter
PF-04950615 200 mg: Every 28 Days	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Change at Week 12	3.4 milligram per deciliter
PF-04950615 200 mg: Every 28 Days	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Change at Week 24	2.2 milligram per deciliter
PF-04950615 300 mg: Every 28 Days	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Change at Week 12	2.8 milligram per deciliter
PF-04950615 300 mg: Every 28 Days	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Change at Week 24	0.2 milligram per deciliter

Comparison: Week 12p-value: 0.28195% CI: [-1.35, 4.63]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.25195% CI: [-1.24, 4.71]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.72495% CI: [-2.43, 3.5]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.00795% CI: [1.21, 7.7]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.01995% CI: [0.63, 7.09]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.22595% CI: [-1.07, 4.51]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.57195% CI: [-1.97, 3.56]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.72595% CI: [-2.25, 3.24]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.26895% CI: [-1.56, 5.57]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.99695% CI: [-3.55, 3.54]Mixed models repeated measures analysis

Secondary

Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo: Every 14 Days	Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Change at Week 12	1.654 milligram per deciliter	Standard Deviation 9.802
Placebo: Every 14 Days	Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Change at Week 24	1.065 milligram per deciliter	Standard Deviation 13.2025
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Change at Week 12	-0.515 milligram per deciliter	Standard Deviation 17.6889
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Change at Week 24	-1.893 milligram per deciliter	Standard Deviation 18.8951
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Change at Week 12	-2.956 milligram per deciliter	Standard Deviation 9.9368
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Change at Week 24	-3.945 milligram per deciliter	Standard Deviation 16.2841
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Change at Week 12	-4.334 milligram per deciliter	Standard Deviation 14.3377
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Change at Week 24	-3.205 milligram per deciliter	Standard Deviation 11.638
Placebo: Every 28 Days	Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Change at Week 12	1.547 milligram per deciliter	Standard Deviation 12.0489
Placebo: Every 28 Days	Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Change at Week 24	2.718 milligram per deciliter	Standard Deviation 12.9153
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Change at Week 12	0.502 milligram per deciliter	Standard Deviation 15.1527
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Change at Week 24	2.191 milligram per deciliter	Standard Deviation 26.1574
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Change at Week 12	-5.195 milligram per deciliter	Standard Deviation 12.9577
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Change at Week 24	-3.281 milligram per deciliter	Standard Deviation 16.9586

Secondary

Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24

Time frame: Baseline, Week 24

Arm	Measure	Value (MEAN)
Placebo: Every 14 Days	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24	-3.6 milligram per deciliter
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24	-32.0 milligram per deciliter
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24	-46.8 milligram per deciliter
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24	-44.7 milligram per deciliter
Placebo: Every 28 Days	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24	-0.6 milligram per deciliter
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24	-24.3 milligram per deciliter
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24	-30.9 milligram per deciliter

p-value: <0.00195% CI: [-39.15, -17.67]Mixed models repeated measures analysis

p-value: <0.00195% CI: [-53.9, -32.51]Mixed models repeated measures analysis

p-value: <0.00195% CI: [-51.66, -30.41]Mixed models repeated measures analysis

p-value: <0.00195% CI: [-33.7, -13.84]Mixed models repeated measures analysis

p-value: <0.00195% CI: [-40.24, -20.49]Mixed models repeated measures analysis

Secondary

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

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo: Every 14 Days	Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Change at Week 12	-5.7 milligram per deciliter	Standard Deviation 26.92
Placebo: Every 14 Days	Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Change at Week 24	-5.4 milligram per deciliter	Standard Deviation 26.84
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Change at Week 12	-37.5 milligram per deciliter	Standard Deviation 22.4
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Change at Week 24	-33.2 milligram per deciliter	Standard Deviation 29.21
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Change at Week 12	-55.0 milligram per deciliter	Standard Deviation 32.75
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Change at Week 24	-55.9 milligram per deciliter	Standard Deviation 38.79
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Change at Week 12	-59.6 milligram per deciliter	Standard Deviation 33.23
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Change at Week 24	-47.3 milligram per deciliter	Standard Deviation 33.71
Placebo: Every 28 Days	Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Change at Week 12	0.6 milligram per deciliter	Standard Deviation 38.04
Placebo: Every 28 Days	Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Change at Week 24	-6.8 milligram per deciliter	Standard Deviation 31.49
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Change at Week 12	-22.9 milligram per deciliter	Standard Deviation 29.05
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Change at Week 24	-26.3 milligram per deciliter	Standard Deviation 22.98
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Change at Week 12	-40.7 milligram per deciliter	Standard Deviation 44.91
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Change at Week 24	-28.9 milligram per deciliter	Standard Deviation 34.5

Secondary

Change From Baseline in Total Cholesterol at Week 12 and 24

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo: Every 14 Days	Change From Baseline in Total Cholesterol at Week 12 and 24	Change at Week 12	-5.6 milligram per deciliter	Standard Deviation 29.58
Placebo: Every 14 Days	Change From Baseline in Total Cholesterol at Week 12 and 24	Change at Week 24	-5.5 milligram per deciliter	Standard Deviation 28.04
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Total Cholesterol at Week 12 and 24	Change at Week 12	-35.8 milligram per deciliter	Standard Deviation 24.73
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Total Cholesterol at Week 12 and 24	Change at Week 24	-31.7 milligram per deciliter	Standard Deviation 32.53
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Total Cholesterol at Week 12 and 24	Change at Week 12	-52.7 milligram per deciliter	Standard Deviation 32.67
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Total Cholesterol at Week 12 and 24	Change at Week 24	-55.0 milligram per deciliter	Standard Deviation 38.67
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Total Cholesterol at Week 12 and 24	Change at Week 12	-58.6 milligram per deciliter	Standard Deviation 32.9
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Total Cholesterol at Week 12 and 24	Change at Week 24	-46.9 milligram per deciliter	Standard Deviation 33.83
Placebo: Every 28 Days	Change From Baseline in Total Cholesterol at Week 12 and 24	Change at Week 12	-0.4 milligram per deciliter	Standard Deviation 40
Placebo: Every 28 Days	Change From Baseline in Total Cholesterol at Week 12 and 24	Change at Week 24	-6.4 milligram per deciliter	Standard Deviation 33.98
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Total Cholesterol at Week 12 and 24	Change at Week 12	-19.5 milligram per deciliter	Standard Deviation 27.39
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Total Cholesterol at Week 12 and 24	Change at Week 24	-24.5 milligram per deciliter	Standard Deviation 25.86
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Total Cholesterol at Week 12 and 24	Change at Week 12	-37.6 milligram per deciliter	Standard Deviation 43.58
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Total Cholesterol at Week 12 and 24	Change at Week 24	-28.6 milligram per deciliter	Standard Deviation 33.61

Secondary

Change From Baseline in Triglycerides at Week 12 and 24

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo: Every 14 Days	Change From Baseline in Triglycerides at Week 12 and 24	Change at Week 12	-14.1 milligram per deciliter	Standard Deviation 54.92
Placebo: Every 14 Days	Change From Baseline in Triglycerides at Week 12 and 24	Change at Week 24	-5.0 milligram per deciliter	Standard Deviation 51.01
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Triglycerides at Week 12 and 24	Change at Week 12	-28.7 milligram per deciliter	Standard Deviation 76.49
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Triglycerides at Week 12 and 24	Change at Week 24	-13.0 milligram per deciliter	Standard Deviation 100.36
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Triglycerides at Week 12 and 24	Change at Week 12	-17.5 milligram per deciliter	Standard Deviation 87.65
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Triglycerides at Week 12 and 24	Change at Week 24	-25.2 milligram per deciliter	Standard Deviation 83.78
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Triglycerides at Week 12 and 24	Change at Week 12	-17.6 milligram per deciliter	Standard Deviation 74.45
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Triglycerides at Week 12 and 24	Change at Week 24	-25.5 milligram per deciliter	Standard Deviation 66.92
Placebo: Every 28 Days	Change From Baseline in Triglycerides at Week 12 and 24	Change at Week 12	9.0 milligram per deciliter	Standard Deviation 66.03
Placebo: Every 28 Days	Change From Baseline in Triglycerides at Week 12 and 24	Change at Week 24	-12.0 milligram per deciliter	Standard Deviation 45.73
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Triglycerides at Week 12 and 24	Change at Week 12	-9.1 milligram per deciliter	Standard Deviation 46.91
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Triglycerides at Week 12 and 24	Change at Week 24	-20.7 milligram per deciliter	Standard Deviation 54.93
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Triglycerides at Week 12 and 24	Change at Week 12	-15.7 milligram per deciliter	Standard Deviation 58.22
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Triglycerides at Week 12 and 24	Change at Week 24	6.0 milligram per deciliter	Standard Deviation 50.52

Secondary

Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo: Every 14 Days	Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Change at Week 12	-12.3 milligram per deciliter	Standard Deviation 50.98
Placebo: Every 14 Days	Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Change at Week 24	-4.8 milligram per deciliter	Standard Deviation 46.55
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Change at Week 12	-11.8 milligram per deciliter	Standard Deviation 35.82
PF-04950615 50 mg: Every 14 Days	Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Change at Week 24	-11.5 milligram per deciliter	Standard Deviation 49.2
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Change at Week 12	-6.0 milligram per deciliter	Standard Deviation 46.43
PF-04950615 100 mg: Every 14 Days	Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Change at Week 24	-12.4 milligram per deciliter	Standard Deviation 38.58
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Change at Week 12	-20.3 milligram per deciliter	Standard Deviation 43.27
PF-04950615 150 mg: Every 14 Days	Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Change at Week 24	-24.3 milligram per deciliter	Standard Deviation 57.43
Placebo: Every 28 Days	Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Change at Week 12	2.5 milligram per deciliter	Standard Deviation 39.66
Placebo: Every 28 Days	Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Change at Week 24	-12.1 milligram per deciliter	Standard Deviation 40.35
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Change at Week 12	-5.8 milligram per deciliter	Standard Deviation 38.21
PF-04950615 200 mg: Every 28 Days	Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Change at Week 24	-15.3 milligram per deciliter	Standard Deviation 47.53
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Change at Week 12	-12.1 milligram per deciliter	Standard Deviation 51.36
PF-04950615 300 mg: Every 28 Days	Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Change at Week 24	2.8 milligram per deciliter	Standard Deviation 41.81

Secondary

Percentage of Participants With Injection Site Adverse Events

Injection site adverse events included injection site bruising, discomfort, erythema, hemorrhage, induration, inflammation, pain, paresthesia, pruritus, swelling, urticaria, reaction and rash.

Time frame: Baseline up to Day 211 for 28 days groups and Baseline up to Day 225 for 14 days groups

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

Arm	Measure	Value (NUMBER)
Placebo: Every 14 Days	Percentage of Participants With Injection Site Adverse Events	0 percentage of participants
PF-04950615 50 mg: Every 14 Days	Percentage of Participants With Injection Site Adverse Events	4.0 percentage of participants
PF-04950615 100 mg: Every 14 Days	Percentage of Participants With Injection Site Adverse Events	0 percentage of participants
PF-04950615 150 mg: Every 14 Days	Percentage of Participants With Injection Site Adverse Events	2.0 percentage of participants
Placebo: Every 28 Days	Percentage of Participants With Injection Site Adverse Events	0 percentage of participants
PF-04950615 200 mg: Every 28 Days	Percentage of Participants With Injection Site Adverse Events	0 percentage of participants
PF-04950615 300 mg: Every 28 Days	Percentage of Participants With Injection Site Adverse Events	2.0 percentage of participants

Secondary

Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)

Time frame: Week 12, 24

Population: FAS included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (NUMBER)
Placebo: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <70 mg/dL	4.3 percentage of participants
Placebo: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <25 mg/dL	0.0 percentage of participants
Placebo: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <25 mg/dL	0.0 percentage of participants
Placebo: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <70 mg/dL	6.4 percentage of participants
Placebo: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <100 mg/dL	48.9 percentage of participants
Placebo: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <100 mg/dL	42.6 percentage of participants
Placebo: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <40 mg/dL	0.0 percentage of participants
Placebo: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <40 mg/dL	0.0 percentage of participants
PF-04950615 50 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <25 mg/dL	4.5 percentage of participants
PF-04950615 50 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <40 mg/dL	6.8 percentage of participants
PF-04950615 50 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <70 mg/dL	55.8 percentage of participants
PF-04950615 50 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <100 mg/dL	86.0 percentage of participants
PF-04950615 50 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <100 mg/dL	90.9 percentage of participants
PF-04950615 50 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <40 mg/dL	4.7 percentage of participants
PF-04950615 50 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <70 mg/dL	50.0 percentage of participants
PF-04950615 50 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <25 mg/dL	0.0 percentage of participants
PF-04950615 100 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <40 mg/dL	16.7 percentage of participants
PF-04950615 100 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <25 mg/dL	4.4 percentage of participants
PF-04950615 100 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <40 mg/dL	22.2 percentage of participants
PF-04950615 100 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <25 mg/dL	4.8 percentage of participants
PF-04950615 100 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <100 mg/dL	91.1 percentage of participants
PF-04950615 100 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <70 mg/dL	66.7 percentage of participants
PF-04950615 100 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <100 mg/dL	95.2 percentage of participants
PF-04950615 100 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <70 mg/dL	73.3 percentage of participants
PF-04950615 150 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <40 mg/dL	47.8 percentage of participants
PF-04950615 150 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <70 mg/dL	68.1 percentage of participants
PF-04950615 150 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <25 mg/dL	10.9 percentage of participants
PF-04950615 150 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <40 mg/dL	17.0 percentage of participants
PF-04950615 150 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <100 mg/dL	91.3 percentage of participants
PF-04950615 150 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <100 mg/dL	91.5 percentage of participants
PF-04950615 150 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <25 mg/dL	2.1 percentage of participants
PF-04950615 150 mg: Every 14 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <70 mg/dL	78.3 percentage of participants
Placebo: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <25 mg/dL	0.0 percentage of participants
Placebo: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <100 mg/dL	44.2 percentage of participants
Placebo: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <70 mg/dL	0 percentage of participants
Placebo: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <70 mg/dL	2.3 percentage of participants
Placebo: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <40 mg/dL	0 percentage of participants
Placebo: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <40 mg/dL	0 percentage of participants
Placebo: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <100 mg/dL	34.8 percentage of participants
Placebo: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <25 mg/dL	0.0 percentage of participants
PF-04950615 200 mg: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <25 mg/dL	0.0 percentage of participants
PF-04950615 200 mg: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <40 mg/dL	2.1 percentage of participants
PF-04950615 200 mg: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <100 mg/dL	64.6 percentage of participants
PF-04950615 200 mg: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <70 mg/dL	33.3 percentage of participants
PF-04950615 200 mg: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <100 mg/dL	78.7 percentage of participants
PF-04950615 200 mg: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <25 mg/dL	2.1 percentage of participants
PF-04950615 200 mg: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <40 mg/dL	8.3 percentage of participants
PF-04950615 200 mg: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <70 mg/dL	21.3 percentage of participants
PF-04950615 300 mg: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <40 mg/dL	32.0 percentage of participants
PF-04950615 300 mg: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <100 mg/dL	78.0 percentage of participants
PF-04950615 300 mg: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <100 mg/dL	79.2 percentage of participants
PF-04950615 300 mg: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <70 mg/dL	58.0 percentage of participants
PF-04950615 300 mg: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <70 mg/dL	43.8 percentage of participants
PF-04950615 300 mg: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <40 mg/dL	6.3 percentage of participants
PF-04950615 300 mg: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 12: <25 mg/dL	6.0 percentage of participants
PF-04950615 300 mg: Every 28 Days	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)	Week 24: <25 mg/dL	2.1 percentage of participants

Comparison: Week 12, Less than 100 mg/dLp-value: <0.00195% CI: [3.997, 56.02]Regression, Logistic

Comparison: Week 12, Less than 100 mg/dLp-value: <0.00195% CI: [7.984, 308.328]Regression, Logistic

Comparison: Week 12, Less than 100 mg/dLp-value: <0.00195% CI: [3.674, 44.892]Regression, Logistic

Comparison: Week 12, Less than 100 mg/dLp-value: 0.0195% CI: [1.304, 7.401]Regression, Logistic

Comparison: Week 12, Less than 100 mg/dLp-value: <0.00195% CI: [2.402, 15.225]Regression, Logistic

Comparison: Week 24, Less than 100 mg/dLp-value: <0.00195% CI: [3.932, 41.495]Regression, Logistic

Comparison: Week 24, Less than 100 mg/dLp-value: <0.00195% CI: [8.33, 163.335]Regression, Logistic

Comparison: Week 24, Less than 100 mg/dLp-value: <0.00195% CI: [5.741, 75.006]Regression, Logistic

Comparison: Week 24, Less than 100 mg/dLp-value: 0.00195% CI: [2.061, 18.764]Regression, Logistic

Comparison: Week 24, Less than 100 mg/dLp-value: 0.00195% CI: [2.06, 18.693]Regression, Logistic

Comparison: Week 12, Less than 70 mg/dLp-value: <0.00195% CI: [5.752, 133.423]Regression, Logistic

Comparison: Week 12, Less than 70 mg/dLp-value: <0.00195% CI: [13.783, 367.564]Regression, Logistic

Comparison: Week 12, Less than 70 mg/dLp-value: <0.00195% CI: [19.855, 510.387]Regression, Logistic

Comparison: Week 12, Less than 70 mg/dL.p-value: <0.001Regression, Logistic

Comparison: Week 24, Less than 70 mg/dL.p-value: <0.00195% CI: [6.336, 98.169]Regression, Logistic

Comparison: Week 24, Less than 70 mg/dL.p-value: <0.00195% CI: [18.094, 353.742]Regression, Logistic

Comparison: Week 24, Less than 70 mg/dL.p-value: <0.00195% CI: [10.621, 166.894]Regression, Logistic

Comparison: Week 24, Less than 70 mg/dL.p-value: 0.02395% CI: [1.396, 98.075]Regression, Logistic

Comparison: Week 24, Less than 70 mg/dLp-value: <0.00195% CI: [4.527, 299.817]Regression, Logistic

Comparison: Week 12, Less than 40 mg/dL.p-value: <0.001Regression, Logistic

Comparison: Week 24, Less than 40 mg/dL.p-value: <0.001Regression, Logistic

Comparison: Week 12, Less than 25 mg/dL.p-value: <0.001Regression, Logistic

Comparison: Week 24, Less than 25 mg/dLp-value: 1Regression, Logistic

Comparison: Week 24, Less than 25 mg/dL.p-value: <0.001Regression, Logistic

Comparison: Week 24, Less than 25 mg/dLp-value: 1Regression, Logistic

Secondary

Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)

Participants with titer value greater than or equal to 4.32 nanogram per milliliter were considered positive.

Time frame: Baseline up to Day 211 for every 28 days groups and Baseline up to Day 225 for every 14 days groups

Population: Analysis set included all participants who received at least 1 dose of PF-04950615.

Arm	Measure	Value (NUMBER)
Placebo: Every 14 Days	Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)	6.0 percentage of participants
PF-04950615 50 mg: Every 14 Days	Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)	3.9 percentage of participants
PF-04950615 100 mg: Every 14 Days	Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)	10.2 percentage of participants
PF-04950615 150 mg: Every 14 Days	Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)	6.0 percentage of participants
Placebo: Every 28 Days	Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)	9.8 percentage of participants

Secondary

Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)
Placebo: Every 14 Days	Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Percent Change at Week 12	2.6 percent change
Placebo: Every 14 Days	Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Percent Change at Week 24	1.4 percent change
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Percent Change at Week 12	2.0 percent change
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Percent Change at Week 24	0.5 percent change
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Percent Change at Week 12	4.9 percent change
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Percent Change at Week 24	0.2 percent change
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Percent Change at Week 12	9.1 percent change
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Percent Change at Week 24	7.2 percent change
Placebo: Every 28 Days	Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Percent Change at Week 12	2.2 percent change
Placebo: Every 28 Days	Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Percent Change at Week 24	1.9 percent change
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Percent Change at Week 12	5.7 percent change
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Percent Change at Week 24	1.0 percent change
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Percent Change at Week 12	4.9 percent change
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24	Percent Change at Week 24	0.3 percent change

Comparison: Week 12p-value: 0.8995% CI: [-10.05, 8.74]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.62595% CI: [-7.04, 11.68]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.17295% CI: [-2.86, 15.94]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.10995% CI: [-0.79, 7.8]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.21895% CI: [-1.6, 6.94]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.81295% CI: [-8.01, 6.29]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.74995% CI: [-8.24, 5.94]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.10895% CI: [-1.29, 12.93]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.75295% CI: [-5.99, 4.34]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.5595% CI: [-6.68, 3.57]Mixed models repeated measures analysis

Secondary

Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)
Placebo: Every 14 Days	Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Percent Change at Week 12	8.1 percent change
Placebo: Every 14 Days	Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Percent Change at Week 24	5.5 percent change
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Percent Change at Week 12	18.4 percent change
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Percent Change at Week 24	15.3 percent change
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Percent Change at Week 12	8.5 percent change
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Percent Change at Week 24	2.8 percent change
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Percent Change at Week 12	8.7 percent change
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Percent Change at Week 24	8.5 percent change
Placebo: Every 28 Days	Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Percent Change at Week 12	5.4 percent change
Placebo: Every 28 Days	Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Percent Change at Week 24	0.6 percent change
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Percent Change at Week 12	3.8 percent change
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Percent Change at Week 24	-1.4 percent change
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Percent Change at Week 12	6.4 percent change
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24	Percent Change at Week 24	-0.7 percent change

Comparison: Week 12p-value: 0.52795% CI: [-21.73, 42.3]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.98195% CI: [-31.49, 32.26]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.97495% CI: [-31.72, 32.8]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.6495% CI: [-8.25, 5.09]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.7595% CI: [-5.61, 7.77]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.50995% CI: [-19.41, 39.01]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.85595% CI: [-31.76, 26.38]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.83995% CI: [-26.39, 32.47]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.39295% CI: [-6.57, 2.59]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.56595% CI: [-5.91, 3.24]Mixed models repeated measures analysis

Secondary

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

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)
Placebo: Every 14 Days	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Percent Change at Week 12	-1.9 percent change
Placebo: Every 14 Days	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Percent Change at Week 24	-1.5 percent change
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Percent Change at Week 12	-23.5 percent change
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Percent Change at Week 24	-23.6 percent change
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Percent Change at Week 12	-32.5 percent change
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Percent Change at Week 24	-32.5 percent change
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Percent Change at Week 12	-37.9 percent change
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Percent Change at Week 24	-28.7 percent change
Placebo: Every 28 Days	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Percent Change at Week 12	3.7 percent change
Placebo: Every 28 Days	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Percent Change at Week 24	-1.4 percent change
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Percent Change at Week 12	-13.5 percent change
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Percent Change at Week 24	-16.8 percent change
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Percent Change at Week 12	-27.1 percent change
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24	Percent Change at Week 24	-20.6 percent change

Comparison: Week 12p-value: <0.00195% CI: [-29.23, -13.92]Mixed models repeated measures analysis

Comparison: Week 12p-value: <0.00195% CI: [-38.19, -22.89]Mixed models repeated measures analysis

Comparison: Week 12p-value: <0.00195% CI: [-43.59, -28.31]Mixed models repeated measures analysis

Comparison: Week 12p-value: <0.00195% CI: [-25.87, -8.41]Mixed models repeated measures analysis

Comparison: Week 12p-value: <0.00195% CI: [-39.45, -21.98]Mixed models repeated measures analysis

Comparison: Week 24p-value: <0.00195% CI: [-30.32, -13.86]Mixed models repeated measures analysis

Comparison: Week 24p-value: <0.00195% CI: [-39.13, -22.77]Mixed models repeated measures analysis

Comparison: Week 24p-value: <0.00195% CI: [-35.38, -19.09]Mixed models repeated measures analysis

Comparison: Week 24p-value: <0.00195% CI: [-22.9, -7.78]Mixed models repeated measures analysis

Comparison: Week 24p-value: <0.00195% CI: [-26.7, -11.59]Mixed models repeated measures analysis

Secondary

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

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)
Placebo: Every 14 Days	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Percent Change at Week 12	1.2 percent change
Placebo: Every 14 Days	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Percent Change at Week 24	-0.3 percent change
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Percent Change at Week 12	4.6 percent change
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Percent Change at Week 24	3.6 percent change
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Percent Change at Week 12	3.8 percent change
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Percent Change at Week 24	0.6 percent change
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Percent Change at Week 12	2.5 percent change
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Percent Change at Week 24	2.3 percent change
Placebo: Every 28 Days	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Percent Change at Week 12	-0.4 percent change
Placebo: Every 28 Days	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Percent Change at Week 24	1.7 percent change
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Percent Change at Week 12	7.2 percent change
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Percent Change at Week 24	4.7 percent change
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Percent Change at Week 12	6.1 percent change
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24	Percent Change at Week 24	1.0 percent change

Comparison: Week 12p-value: 0.24695% CI: [-2.38, 9.21]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.37195% CI: [-3.14, 8.38]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.64395% CI: [-4.4, 7.1]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.01895% CI: [1.33, 13.99]Mixed models repeated measures analysis

Comparison: Week 12p-value: 0.04395% CI: [0.22, 12.83]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.1695% CI: [-1.56, 9.36]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.75895% CI: [-4.56, 6.25]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.34795% CI: [-2.81, 7.95]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.34395% CI: [-3.22, 9.21]Mixed models repeated measures analysis

Comparison: Week 24p-value: 0.82495% CI: [-6.87, 5.48]Mixed models repeated measures analysis

Secondary

Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo: Every 14 Days	Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Percent Change at Week 12	6.11 percent change	Standard Deviation 30.573
Placebo: Every 14 Days	Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Percent Change at Week 24	8.78 percent change	Standard Deviation 43.596
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Percent Change at Week 12	40.43 percent change	Standard Deviation 333.949
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Percent Change at Week 24	43.97 percent change	Standard Deviation 330.964
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Percent Change at Week 12	-11.89 percent change	Standard Deviation 22.517
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Percent Change at Week 24	-10.18 percent change	Standard Deviation 26.612
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Percent Change at Week 12	-9.01 percent change	Standard Deviation 35.644
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Percent Change at Week 24	0.03 percent change	Standard Deviation 50.256
Placebo: Every 28 Days	Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Percent Change at Week 12	9.28 percent change	Standard Deviation 33.809
Placebo: Every 28 Days	Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Percent Change at Week 24	10.18 percent change	Standard Deviation 32.604
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Percent Change at Week 12	-0.91 percent change	Standard Deviation 26.271
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Percent Change at Week 24	-0.79 percent change	Standard Deviation 25.066
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Percent Change at Week 12	-11.93 percent change	Standard Deviation 23.893
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24	Percent Change at Week 24	-5.42 percent change	Standard Deviation 22.451

Secondary

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)
Placebo: Every 14 Days	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24	Percent Change at Week 12	0.6 percent change
Placebo: Every 14 Days	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24	Percent Change at Week 24	-0.9 percent change
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24	Percent Change at Week 12	-34.4 percent change
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24	Percent Change at Week 24	-30.0 percent change
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24	Percent Change at Week 12	-41.7 percent change
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24	Percent Change at Week 24	-41.0 percent change
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24	Percent Change at Week 12	-52.5 percent change
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24	Percent Change at Week 24	-40.0 percent change
Placebo: Every 28 Days	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24	Percent Change at Week 12	6.7 percent change
Placebo: Every 28 Days	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24	Percent Change at Week 24	2.4 percent change
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24	Percent Change at Week 12	-20.2 percent change
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24	Percent Change at Week 24	-21.3 percent change
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24	Percent Change at Week 12	-34.4 percent change
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24	Percent Change at Week 24	-26.6 percent change

Comparison: Week 12p-value: <0.00195% CI: [-44.91, -25.1]Mixed models repeated measures analysis

Comparison: Week 12p-value: <0.00195% CI: [-52.3, -32.33]Mixed models repeated measures analysis

Comparison: Week 12p-value: <0.00195% CI: [-62.97, -43.27]Mixed models repeated measures analysis

Comparison: Week 12p-value: <0.00195% CI: [-38.25, -15.67]Mixed models repeated measures analysis

Comparison: Week 12p-value: <0.00195% CI: [-52.32, -29.94]Mixed models repeated measures analysis

Comparison: Week 24p-value: <0.00195% CI: [-38.42, -19.77]Mixed models repeated measures analysis

Comparison: Week 24p-value: <0.00195% CI: [-49.43, -30.86]Mixed models repeated measures analysis

Comparison: Week 24p-value: <0.00195% CI: [-48.37, -29.94]Mixed models repeated measures analysis

Comparison: Week 24p-value: <0.00195% CI: [-32.88, -14.7]Mixed models repeated measures analysis

Comparison: Week 24p-value: <0.00195% CI: [-38.13, -20.04]Mixed models repeated measures analysis

Secondary

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

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo: Every 14 Days	Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Percent Change at Week 12	-2.28 percent change	Standard Deviation 20.234
Placebo: Every 14 Days	Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Percent Change at Week 24	-2.02 percent change	Standard Deviation 18.694
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Percent Change at Week 12	-28.34 percent change	Standard Deviation 15.836
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Percent Change at Week 24	-24.89 percent change	Standard Deviation 18.938
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Percent Change at Week 12	-38.52 percent change	Standard Deviation 21.362
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Percent Change at Week 24	-38.02 percent change	Standard Deviation 23.039
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Percent Change at Week 12	-44.86 percent change	Standard Deviation 24.258
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Percent Change at Week 24	-34.02 percent change	Standard Deviation 22.788
Placebo: Every 28 Days	Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Percent Change at Week 12	2.76 percent change	Standard Deviation 20.337
Placebo: Every 28 Days	Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Percent Change at Week 24	-1.78 percent change	Standard Deviation 17.145
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Percent Change at Week 12	-17.30 percent change	Standard Deviation 22.324
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Percent Change at Week 24	-19.39 percent change	Standard Deviation 17.304
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Percent Change at Week 12	-28.68 percent change	Standard Deviation 30.857
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24	Percent Change at Week 24	-19.99 percent change	Standard Deviation 24.887

Secondary

Percent Change From Baseline in Total Cholesterol at Week 12 and 24

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo: Every 14 Days	Percent Change From Baseline in Total Cholesterol at Week 12 and 24	Percent Change at Week 12	-2.35 percent change	Standard Deviation 14.406
Placebo: Every 14 Days	Percent Change From Baseline in Total Cholesterol at Week 12 and 24	Percent Change at Week 24	-2.31 percent change	Standard Deviation 13.481
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Total Cholesterol at Week 12 and 24	Percent Change at Week 12	-18.96 percent change	Standard Deviation 12.299
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Total Cholesterol at Week 12 and 24	Percent Change at Week 24	-16.70 percent change	Standard Deviation 15.86
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Total Cholesterol at Week 12 and 24	Percent Change at Week 12	-26.45 percent change	Standard Deviation 14.943
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Total Cholesterol at Week 12 and 24	Percent Change at Week 24	-27.77 percent change	Standard Deviation 16.993
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Total Cholesterol at Week 12 and 24	Percent Change at Week 12	-31.64 percent change	Standard Deviation 18.012
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Total Cholesterol at Week 12 and 24	Percent Change at Week 24	-24.31 percent change	Standard Deviation 16.491
Placebo: Every 28 Days	Percent Change From Baseline in Total Cholesterol at Week 12 and 24	Percent Change at Week 12	1.24 percent change	Standard Deviation 16.624
Placebo: Every 28 Days	Percent Change From Baseline in Total Cholesterol at Week 12 and 24	Percent Change at Week 24	-1.35 percent change	Standard Deviation 14.426
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Total Cholesterol at Week 12 and 24	Percent Change at Week 12	-10.51 percent change	Standard Deviation 15.318
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Total Cholesterol at Week 12 and 24	Percent Change at Week 24	-12.38 percent change	Standard Deviation 13.365
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Total Cholesterol at Week 12 and 24	Percent Change at Week 12	-19.44 percent change	Standard Deviation 22.054
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Total Cholesterol at Week 12 and 24	Percent Change at Week 24	-14.61 percent change	Standard Deviation 17.302

Secondary

Percent Change From Baseline in Triglycerides at Week 12 and 24

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo: Every 14 Days	Percent Change From Baseline in Triglycerides at Week 12 and 24	Percent Change at Week 24	5.11 percent change	Standard Deviation 52.717
Placebo: Every 14 Days	Percent Change From Baseline in Triglycerides at Week 12 and 24	Percent Change at Week 12	-1.17 percent change	Standard Deviation 42.789
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Triglycerides at Week 12 and 24	Percent Change at Week 12	-5.01 percent change	Standard Deviation 40.253
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Triglycerides at Week 12 and 24	Percent Change at Week 24	6.49 percent change	Standard Deviation 51.96
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Triglycerides at Week 12 and 24	Percent Change at Week 12	-7.13 percent change	Standard Deviation 35.229
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Triglycerides at Week 12 and 24	Percent Change at Week 24	-10.29 percent change	Standard Deviation 32.708
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Triglycerides at Week 12 and 24	Percent Change at Week 12	-8.93 percent change	Standard Deviation 50.315
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Triglycerides at Week 12 and 24	Percent Change at Week 24	-10.34 percent change	Standard Deviation 32.992
Placebo: Every 28 Days	Percent Change From Baseline in Triglycerides at Week 12 and 24	Percent Change at Week 24	-2.01 percent change	Standard Deviation 29.868
Placebo: Every 28 Days	Percent Change From Baseline in Triglycerides at Week 12 and 24	Percent Change at Week 12	13.92 percent change	Standard Deviation 49.563
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Triglycerides at Week 12 and 24	Percent Change at Week 12	-1.88 percent change	Standard Deviation 28.283
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Triglycerides at Week 12 and 24	Percent Change at Week 24	-7.29 percent change	Standard Deviation 35.954
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Triglycerides at Week 12 and 24	Percent Change at Week 24	13.90 percent change	Standard Deviation 45.386
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Triglycerides at Week 12 and 24	Percent Change at Week 12	-5.91 percent change	Standard Deviation 39.286

Secondary

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

Time frame: Baseline, Week 12, 24

Population: Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo: Every 14 Days	Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Percent Change at Week 12	9.62 percent change	Standard Deviation 71.415
Placebo: Every 14 Days	Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Percent Change at Week 24	20.26 percent change	Standard Deviation 101.188
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Percent Change at Week 12	2.81 percent change	Standard Deviation 54.888
PF-04950615 50 mg: Every 14 Days	Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Percent Change at Week 24	5.34 percent change	Standard Deviation 59.092
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Percent Change at Week 12	-3.77 percent change	Standard Deviation 54.845
PF-04950615 100 mg: Every 14 Days	Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Percent Change at Week 24	-9.78 percent change	Standard Deviation 39.626
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Percent Change at Week 12	-15.61 percent change	Standard Deviation 36.099
PF-04950615 150 mg: Every 14 Days	Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Percent Change at Week 24	-13.28 percent change	Standard Deviation 44.197
Placebo: Every 28 Days	Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Percent Change at Week 12	17.58 percent change	Standard Deviation 54.707
Placebo: Every 28 Days	Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Percent Change at Week 24	-3.60 percent change	Standard Deviation 40.646
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Percent Change at Week 12	17.32 percent change	Standard Deviation 94.238
PF-04950615 200 mg: Every 28 Days	Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Percent Change at Week 24	15.72 percent change	Standard Deviation 142.996
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Percent Change at Week 12	2.16 percent change	Standard Deviation 80.149
PF-04950615 300 mg: Every 28 Days	Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24	Percent Change at Week 24	33.89 percent change	Standard Deviation 131.723

Secondary

Plasma Concentration of PF-04950615 at Week 12 and 24

Time frame: Week 12, 24

Population: Analysis set included all participants who received at least 1 dose of PF-04950615. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo: Every 14 Days	Plasma Concentration of PF-04950615 at Week 12 and 24	Week 12	1.0157 Microgram per milliliter	Standard Deviation 2.09363
Placebo: Every 14 Days	Plasma Concentration of PF-04950615 at Week 12 and 24	Week 24	0.7951 Microgram per milliliter	Standard Deviation 0.78411
PF-04950615 50 mg: Every 14 Days	Plasma Concentration of PF-04950615 at Week 12 and 24	Week 12	1.4737 Microgram per milliliter	Standard Deviation 1.35406
PF-04950615 50 mg: Every 14 Days	Plasma Concentration of PF-04950615 at Week 12 and 24	Week 24	1.1605 Microgram per milliliter	Standard Deviation 0.72802
PF-04950615 100 mg: Every 14 Days	Plasma Concentration of PF-04950615 at Week 12 and 24	Week 12	2.0516 Microgram per milliliter	Standard Deviation 2.25916
PF-04950615 100 mg: Every 14 Days	Plasma Concentration of PF-04950615 at Week 12 and 24	Week 24	1.6500 Microgram per milliliter	Standard Deviation 2.7721
PF-04950615 150 mg: Every 14 Days	Plasma Concentration of PF-04950615 at Week 12 and 24	Week 24	0.3752 Microgram per milliliter	Standard Deviation 0.41778
PF-04950615 150 mg: Every 14 Days	Plasma Concentration of PF-04950615 at Week 12 and 24	Week 12	0.5035 Microgram per milliliter	Standard Deviation 0.534
Placebo: Every 28 Days	Plasma Concentration of PF-04950615 at Week 12 and 24	Week 12	2.2010 Microgram per milliliter	Standard Deviation 3.91444
Placebo: Every 28 Days	Plasma Concentration of PF-04950615 at Week 12 and 24	Week 24	1.6459 Microgram per milliliter	Standard Deviation 4.20348

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026

Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

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

Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24

Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24

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

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

Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24

Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24

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

Change From Baseline in Total Cholesterol at Week 12 and 24

Change From Baseline in Triglycerides at Week 12 and 24

Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24

Percentage of Participants With Injection Site Adverse Events

Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)

Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)

Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24

Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24

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

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

Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24

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

Percent Change From Baseline in Total Cholesterol at Week 12 and 24

Percent Change From Baseline in Triglycerides at Week 12 and 24

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

Plasma Concentration of PF-04950615 at Week 12 and 24