Trial Outcomes & Findings for A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins (NCT NCT01350141)

Last Updated: 2017-11-08

Results Overview

Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

Baseline, Day 85

Results posted on

2017-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 1 mg/kg Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 3 mg/kg Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
Overall Study STARTED	15	15	16
Overall Study Treated	14	15	16
Overall Study COMPLETED	12	15	15
Overall Study NOT COMPLETED	3	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 3 mg/kg Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	1	0
Overall Study Randomized but not treated	1	0

Baseline Characteristics

A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=14 Participants Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 1 mg/kg n=15 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 3 mg/kg n=16 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	Total n=45 Participants Total of all reporting groups
Age, Continuous	54.1 years STANDARD_DEVIATION 10.9 • n=5 Participants	56.3 years STANDARD_DEVIATION 10.9 • n=7 Participants	57.6 years STANDARD_DEVIATION 9.0 • n=5 Participants	56 years STANDARD_DEVIATION 10.1 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	22 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Day 85

Population: Efficacy analysis set included all participants who received at least 1 dose of study medication and completed the Day 85 visit or dropped out prematurely, whichever was earlier. "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 1 mg/kg n=15 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 3 mg/kg n=14 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85	4.05 percent change Standard Deviation 21.688	-14.95 percent change Standard Deviation 19.016	-44.84 percent change Standard Deviation 27.186

SECONDARY outcome

Timeframe: Day 29, 57, 85

Population: Efficacy analysis set. "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number of participants analyzed" signifies those participants who were evaluable for this measure at given time points, for each group respectively.

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 1 mg/kg n=15 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 3 mg/kg n=16 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) Day 29 less than 100 mg/dL	15.4 Percentage of participants	86.7 Percentage of participants	100 Percentage of participants
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) Day 57 less than 70 mg/dL	8.3 Percentage of participants	13.3 Percentage of participants	62.5 Percentage of participants
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) Day 29 less than 70 mg/dL	0.0 Percentage of participants	20.0 Percentage of participants	80.0 Percentage of participants
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) Day 57 less than 100 mg/dL	33.3 Percentage of participants	73.3 Percentage of participants	87.5 Percentage of participants
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) Day 85 less than 70 mg/dL	0.0 Percentage of participants	6.7 Percentage of participants	50.0 Percentage of participants
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) Day 85 less than 100 mg/dL	33.3 Percentage of participants	73.3 Percentage of participants	92.9 Percentage of participants

SECONDARY outcome

Timeframe: Day 29, 57, 85

Population: Efficacy analysis set. "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number of Participants Analyzed" signifies those participants who were evaluable for this measure at given time points, for each group respectively.

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 1 mg/kg n=15 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 3 mg/kg n=16 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) Day 85	0.0 percentage of participants	20.0 percentage of participants	71.4 percentage of participants
Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) Day 29	0.0 percentage of participants	13.3 percentage of participants	100 percentage of participants
Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) Day 57	8.3 percentage of participants	26.7 percentage of participants	75.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Day 29, 57, 85

Population: Efficacy analysis set. 'Number of participants analyzed' = participants who were evaluable for this measure at given time points for each arm. Results for change at Day 85 for ApoB and ApoA1 were not reported as data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.

Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 1 mg/kg n=15 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 3 mg/kg n=16 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Baseline TC	191.14 mg/dL Standard Deviation 27.968	189.07 mg/dL Standard Deviation 26.443	195.34 mg/dL Standard Deviation 46.904
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Baseline non-HDL-C	140.43 mg/dL Standard Deviation 24.031	138.43 mg/dL Standard Deviation 29.850	146.97 mg/dL Standard Deviation 44.046
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Baseline TG	122.14 mg/dL Standard Deviation 56.077	156.50 mg/dL Standard Deviation 76.013	109.91 mg/dL Standard Deviation 45.854
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Baseline ApoB	91.57 mg/dL Standard Deviation 21.425	99.67 mg/dL Standard Deviation 21.784	100.88 mg/dL Standard Deviation 24.916
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Change at Day 29 TG	-5.38 mg/dL Standard Deviation 42.455	-23.37 mg/dL Standard Deviation 64.145	-26.00 mg/dL Standard Deviation 39.128
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Change at Day 29 ApoB	6.77 mg/dL Standard Deviation 17.758	-8.80 mg/dL Standard Deviation 14.561	-43.75 mg/dL Standard Deviation 12.520
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Change at Day 57 TC	-12.79 mg/dL Standard Deviation 30.000	-22.87 mg/dL Standard Deviation 33.173	-52.66 mg/dL Standard Deviation 24.873
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Change at Day 57 non-HDL-C	-10.79 mg/dL Standard Deviation 31.447	-22.63 mg/dL Standard Deviation 29.960	-57.22 mg/dL Standard Deviation 29.026
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Change at Day 57 ApoB	7.75 mg/dL Standard Deviation 22.483	-8.47 mg/dL Standard Deviation 19.588	-32.20 mg/dL Standard Deviation 20.772
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Change at Day 57 ApoA1	0.50 mg/dL Standard Deviation 23.240	-1.27 mg/dL Standard Deviation 15.369	1.67 mg/dL Standard Deviation 21.043
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Change at Day 85 TG	6.17 mg/dL Standard Deviation 48.767	-21.10 mg/dL Standard Deviation 36.414	-12.77 mg/dL Standard Deviation 41.558
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Baseline HDL-C	50.71 mg/dL Standard Deviation 12.277	50.63 mg/dL Standard Deviation 11.484	48.38 mg/dL Standard Deviation 12.905
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Baseline ApoA1	140.79 mg/dL Standard Deviation 25.057	146.73 mg/dL Standard Deviation 23.639	143.81 mg/dL Standard Deviation 31.503
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Change at Day 29 HDL-C	0.92 mg/dL Standard Deviation 10.620	-0.43 mg/dL Standard Deviation 4.330	5.53 mg/dL Standard Deviation 5.051
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Change at Day 29 TC	1.46 mg/dL Standard Deviation 20.821	-23.00 mg/dL Standard Deviation 16.566	-64.60 mg/dL Standard Deviation 22.634
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Change at Day 29 non-HDL-C	0.54 mg/dL Standard Deviation 17.159	-22.57 mg/dL Standard Deviation 16.804	-71.40 mg/dL Standard Deviation 22.392
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Change at Day 29 ApoA1	6.15 mg/dL Standard Deviation 28.705	-2.80 mg/dL Standard Deviation 17.350	8.58 mg/dL Standard Deviation 21.245
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Change at Day 57 HDL-C	-2.00 mg/dL Standard Deviation 7.138	-0.23 mg/dL Standard Deviation 5.672	4.56 mg/dL Standard Deviation 8.072
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Change at Day 57 TG	-5.88 mg/dL Standard Deviation 67.487	-17.90 mg/dL Standard Deviation 44.184	-23.97 mg/dL Standard Deviation 19.365
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Change at Day 85 HDL-C	-1.42 mg/dL Standard Deviation 5.684	3.30 mg/dL Standard Deviation 6.959	1.79 mg/dL Standard Deviation 8.398
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Change at Day 85 TC	3.58 mg/dL Standard Deviation 26.618	-17.60 mg/dL Standard Deviation 28.357	-66.07 mg/dL Standard Deviation 45.818
Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Change at Day 85 non-HDL	5.00 mg/dL Standard Deviation 27.376	-20.90 mg/dL Standard Deviation 25.716	-64.32 mg/dL Standard Deviation 50.664

SECONDARY outcome

Timeframe: Baseline, Day 29, 57, 85

Population: Efficacy analysis set. "Number of participants analyzed" = participants who were evaluable for this measure at given time points for each arm. Results for percent change at Day 85 for ApoB and ApoA1 were not reported as data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 1 mg/kg n=15 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 3 mg/kg n=16 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Percent change at Day 29 HDL-C	0.50 percent change Standard Deviation 17.279	-1.09 percent change Standard Deviation 7.935	11.93 percent change Standard Deviation 13.039
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Percent change at Day 29 TC	0.64 percent change Standard Deviation 10.318	-12.63 percent change Standard Deviation 9.125	-35.00 percent change Standard Deviation 13.281
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Percent change at Day 29 non-HDL-C	0.74 percent change Standard Deviation 12.018	-17.84 percent change Standard Deviation 14.222	-52.65 percent change Standard Deviation 17.491
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Percent change at Day 29 TG	1.54 percent change Standard Deviation 38.088	-11.15 percent change Standard Deviation 32.714	-17.18 percent change Standard Deviation 23.596
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Percent change at Day 29 ApoB	11.65 percent change Standard Deviation 26.113	-7.59 percent change Standard Deviation 13.739	-43.43 percent change Standard Deviation 11.125
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Percent change at Day 29 ApoA1	5.63 percent change Standard Deviation 23.400	-1.45 percent change Standard Deviation 10.716	8.34 percent change Standard Deviation 16.131
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Percent change at Day 57 HDL-C	-3.17 percent change Standard Deviation 14.071	-0.80 percent change Standard Deviation 10.784	8.52 percent change Standard Deviation 15.458
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Percent change at Day 57 TC	-7.69 percent change Standard Deviation 17.098	-11.42 percent change Standard Deviation 16.477	-26.58 percent change Standard Deviation 11.010
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Percent change at Day 57 non-HDL-C	-8.79 percent change Standard Deviation 23.929	-14.74 percent change Standard Deviation 19.775	-37.95 percent change Standard Deviation 15.373
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Percent change at Day 57 TG	-3.94 percent change Standard Deviation 45.205	-2.56 percent change Standard Deviation 33.634	-20.56 percent change Standard Deviation 15.081
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Percent change at Day 57 ApoB	11.56 percent change Standard Deviation 25.094	-7.03 percent change Standard Deviation 17.796	-30.35 percent change Standard Deviation 17.065
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Percent change at Day 85 HDL-C	-1.75 percent change Standard Deviation 10.360	5.64 percent change Standard Deviation 12.221	3.18 percent change Standard Deviation 16.233
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Percent change at Day 85 TC	1.81 percent change Standard Deviation 13.580	-9.36 percent change Standard Deviation 14.579	-32.16 percent change Standard Deviation 20.664
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Percent change at Day 85 non-HDL-C	3.28 percent change Standard Deviation 19.529	-14.35 percent change Standard Deviation 17.206	-40.37 percent change Standard Deviation 27.589
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Percent change at Day 85 TG	6.17 percent change Standard Deviation 36.703	-8.28 percent change Standard Deviation 24.530	-11.49 percent change Standard Deviation 32.647
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 Percent change at Day 57 ApoA1	2.41 percent change Standard Deviation 19.469	-0.02 percent change Standard Deviation 10.503	1.72 percent change Standard Deviation 15.505

SECONDARY outcome

Timeframe: Day 1 up to Day 141

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

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, TESAEs and treatment-related TEAEs were reported.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 1 mg/kg n=15 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 3 mg/kg n=16 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) TEAEs (All causalities)	9 Participants	12 Participants	9 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Treatment related TEAEs	2 Participants	3 Participants	4 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) TESAEs (All causalities)	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 up to Day 141

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

An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Investigator assessed adverse events as mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) or severe (interferes significantly with participant's usual function). All causality TEAEs were assessed for severity. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 1 mg/kg n=15 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 3 mg/kg n=16 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity Mild	12 Treatment-emergent AEs	34 Treatment-emergent AEs	20 Treatment-emergent AEs
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity Moderate	2 Treatment-emergent AEs	19 Treatment-emergent AEs	7 Treatment-emergent AEs
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity Severe	0 Treatment-emergent AEs	0 Treatment-emergent AEs	0 Treatment-emergent AEs

SECONDARY outcome

Timeframe: Screening up to Day 141

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

Criteria for clinically significant laboratory abnormalities were based on investigator's discretion. Total number of participants who met the criteria for any laboratory abnormal findings were reported. Laboratory parameters included: hematology, coagulation, liver function, renal function, electrolytes, hormones, chemistry and urinalysis. Screening was 21 days prior to start of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 1 mg/kg n=15 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 3 mg/kg n=16 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
Number of Participants With Clinically Significant Laboratory Abnormalities	12 Participants	15 Participants	16 Participants

SECONDARY outcome

Timeframe: Screening up to Day 141

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

Number of participants with clinically significant changes in vital signs and ECG findings were reported. Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (\>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of \>=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of \>=25 percent (%) for baseline value of greater than 200 millisecond (msec) or maximum increase of \>=50% for baseline value of less than or equal to (\<=) 200 msec for PR and QRS interval, maximum increase from baseline of greater than (\>) 30 to \<=60 msec and maximum increase from baseline of \>60 msec for QT interval corrected using the Fridericia's formula (QTCF). Screening was 21 days prior to start of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=14 Participants Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 1 mg/kg n=15 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 3 mg/kg n=16 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters Supine systolic BP: Maximum increase >=30mmHg	0 Participants	2 Participants	2 Participants
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters Supine diastolic BP: Maximum increase >=20mmHg	2 Participants	0 Participants	3 Participants
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters Supine diastolic BP: Maximum decrease >=20mmHg	2 Participants	4 Participants	1 Participants
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters Supine systolic BP: Maximum decrease >=30mmHg	1 Participants	3 Participants	3 Participants
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters PR interval: >=25/50% increase	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters QRS interval: >=25/50% increase	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters QTCF: Maximum increase >30 to <=60 msec	3 Participants	1 Participants	1 Participants
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters QTCF: Maximum increase >60 msec	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 up to Day 141

Population: Analysis set included all participants who received at least 1 dose of PF-04950615 (RN316).

Human serum samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value \>=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo n=15 Participants Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 1 mg/kg n=16 Participants Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 3 mg/kg Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA)	0 participants	0 participants	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

PF-04950615 (RN316) 1 mg/kg

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

PF-04950615 (RN316) 3 mg/kg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=14 participants at risk Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 1 mg/kg n=15 participants at risk Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.	PF-04950615 (RN316) 3 mg/kg n=16 participants at risk Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
General disorders Non-cardiac chest pain	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.	6.7% 1/15 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.

Other adverse events

Additional Information

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Results disclosure agreements

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