Clinical Trial Results:
A Phase II, Randomized, PlaceboControlled, DoubleBlind Study of the Safety and Efficacy of MPSK3169A in Patients with Coronary Heart Disease or High Risk of Coronary Heart Disease
Summary


EudraCT number 
201200019141 
Trial protocol 
HU DE CZ SK 
Global end of trial date 
22 Jul 2013

Results information


Results version number 
v1(current) 
This version publication date 
04 Mar 2016

First version publication date 
04 Mar 2016

Other versions 
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information


Trial identification


Sponsor protocol code 
GC28210


Additional study identifiers


ISRCTN number 
  
US NCT number 
NCT01609140  
WHO universal trial number (UTN) 
  
Sponsors


Sponsor organisation name 
F. HoffmannLa Roche AG


Sponsor organisation address 
Grenzacherstrasse 124, CH4070, Basel, Switzerland,


Public contact 
Roche Trial Information Hotline, F. HoffmannLa Roche AG, +41 61 6878333, global.trial_information@roche.com


Scientific contact 
Roche Trial Information Hotline, F. HoffmannLa Roche AG, +41 61 6878333, global.trial_information@roche.com


Paediatric regulatory details


Is trial part of an agreed paediatric investigation plan (PIP) 
No


Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? 
No


Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? 
No


Results analysis stage


Analysis stage 
Final


Date of interim/final analysis 
19 Sep 2013


Is this the analysis of the primary completion data? 
No


Global end of trial reached? 
Yes


Global end of trial date 
22 Jul 2013


Was the trial ended prematurely? 
No


General information about the trial


Main objective of the trial 
To evaluate the safety and efficacy of MPSK3169A on top of standardofcare (SOC) statin in participants with a lowdensity lipoprotein cholesterol (LDLc) of 90−250 milligrams per deciliter (mg/dL) and either coronary heart disease (CHD) or a CHD risk equivalent.


Protection of trial subjects 
Efforts to minimize risk included the following: judicious eligibility of participants who may benefit from LDLc lowering because of a combination of high cardiovascular risk and LDLc levels well above the goal of 70 mg/dL, use of SOC statin therapy for all participants, regular safety evaluations overseen by the investigator, study overseen by an internal monitoring committee (IMC), and the use of a minimum threshold of LDLc below which MPSK3169A would be withheld. This study was conducted in full conformance with the International Conference on Harmonisation (ICH) E6 guideline for Good Clinical Practice (GCP) and the principles of the Declaration of Helsinki or the laws and regulations of the country in which the research was conducted, whichever afforded the greater protection to the individual.


Background therapy 
All participants regardless of treatment assignment received SOC treatment with statins. The type and dose of statin therapy was not changed during the runin, treatment, or followup periods of the study.  
Evidence for comparator 
  
Actual start date of recruitment 
21 May 2012


Long term followup planned 
No


Independent data monitoring committee (IDMC) involvement? 
Yes


Population of trial subjects


Number of subjects enrolled per country 

Country: Number of subjects enrolled 
Norway: 21


Country: Number of subjects enrolled 
Slovakia: 10


Country: Number of subjects enrolled 
Czech Republic: 9


Country: Number of subjects enrolled 
Germany: 1


Country: Number of subjects enrolled 
Hungary: 13


Country: Number of subjects enrolled 
Canada: 44


Country: Number of subjects enrolled 
New Zealand: 9


Country: Number of subjects enrolled 
South Africa: 4


Country: Number of subjects enrolled 
United States: 137


Worldwide total number of subjects 
248


EEA total number of subjects 
54


Number of subjects enrolled per age group 

In utero 
0


Preterm newborn  gestational age < 37 wk 
0


Newborns (027 days) 
0


Infants and toddlers (28 days23 months) 
0


Children (211 years) 
0


Adolescents (1217 years) 
0


Adults (1864 years) 
125


From 65 to 84 years 
123


85 years and over 
0



Recruitment


Recruitment details 
  
Preassignment


Screening details 
Participants who met all of the eligibility criteria except the inclusion criterion pertaining to statins and other lipidmodifying therapies entered runin period of 6 weeks until they were on stable SOC statin therapy for at least 4 weeks, and were off prohibited lipidmodifying therapies for at least 4 weeks (or 6 weeks in the case of fibrates).  
Period 1


Period 1 title 
Treatment Period (overall period)


Is this the baseline period? 
Yes  
Allocation method 
Randomised  controlled


Blinding used 
Double blind  
Roles blinded 
Subject, Investigator  
Arms


Are arms mutually exclusive 
Yes


Arm title

MPSK3169A 400 mg once every 4 weeks (Q4W)  
Arm description 
Participants received 400 mg of MPSK3169A Q4W subcutaneously for approximately 24 weeks.  
Arm type 
Experimental  
Investigational medicinal product name 
MPSK3169A


Investigational medicinal product code 
RO6801831


Other name 

Pharmaceutical forms 
Solution for injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
All participants in the study received subcutaneous doses of MPSK3169A or matching placebo every four weeks.


Arm title

MPSK3169A 200 mg Q8W  
Arm description 
Participants received 200 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.  
Arm type 
Experimental  
Investigational medicinal product name 
MPSK3169A


Investigational medicinal product code 
RO6801831


Other name 

Pharmaceutical forms 
Solution for injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
All participants in the study received subcutaneous doses of MPSK3169A or matching placebo every four weeks.


Arm title

MPSK3169A 400 mg Q8W  
Arm description 
Participants received 400 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.  
Arm type 
Experimental  
Investigational medicinal product name 
MPSK3169A


Investigational medicinal product code 
RO6801831


Other name 

Pharmaceutical forms 
Solution for injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
All participants in the study received subcutaneous doses of MPSK3169A or matching placebo every four weeks.


Arm title

MPSK3169A 800 mg Q8W  
Arm description 
Participants received 800 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.  
Arm type 
Experimental  
Investigational medicinal product name 
MPSK3169A


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Solution for injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
All participants in the study received subcutaneous doses of MPSK3169A or matching placebo every four weeks.


Arm title

MPSK3169A 800 mg Q12W  
Arm description 
Participants received 800 mg of MPSK3169A Q12W subcutaneously for approximately 24 weeks.  
Arm type 
Experimental  
Investigational medicinal product name 
MPSK3169A


Investigational medicinal product code 
RO6801831


Other name 

Pharmaceutical forms 
Solution for injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
All participants in the study received subcutaneous doses of MPSK3169A or matching placebo every four weeks.


Arm title

Placebo  
Arm description 
Participants received matching placebo injections subcutaneously for approximately 24 weeks.  
Arm type 
Placebo  
Investigational medicinal product name 
Placebo


Investigational medicinal product code 
Placebo


Other name 

Pharmaceutical forms 
Solution for injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
All participants in the study received subcutaneous doses of matching placebo every four weeks.





Baseline characteristics reporting groups


Reporting group title 
MPSK3169A 400 mg once every 4 weeks (Q4W)


Reporting group description 
Participants received 400 mg of MPSK3169A Q4W subcutaneously for approximately 24 weeks.  
Reporting group title 
MPSK3169A 200 mg Q8W


Reporting group description 
Participants received 200 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.  
Reporting group title 
MPSK3169A 400 mg Q8W


Reporting group description 
Participants received 400 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.  
Reporting group title 
MPSK3169A 800 mg Q8W


Reporting group description 
Participants received 800 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.  
Reporting group title 
MPSK3169A 800 mg Q12W


Reporting group description 
Participants received 800 mg of MPSK3169A Q12W subcutaneously for approximately 24 weeks.  
Reporting group title 
Placebo


Reporting group description 
Participants received matching placebo injections subcutaneously for approximately 24 weeks.  



End points reporting groups


Reporting group title 
MPSK3169A 400 mg once every 4 weeks (Q4W)


Reporting group description 
Participants received 400 mg of MPSK3169A Q4W subcutaneously for approximately 24 weeks.  
Reporting group title 
MPSK3169A 200 mg Q8W


Reporting group description 
Participants received 200 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.  
Reporting group title 
MPSK3169A 400 mg Q8W


Reporting group description 
Participants received 400 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.  
Reporting group title 
MPSK3169A 800 mg Q8W


Reporting group description 
Participants received 800 mg of MPSK3169A Q8W subcutaneously for approximately 24 weeks.  
Reporting group title 
MPSK3169A 800 mg Q12W


Reporting group description 
Participants received 800 mg of MPSK3169A Q12W subcutaneously for approximately 24 weeks.  
Reporting group title 
Placebo


Reporting group description 
Participants received matching placebo injections subcutaneously for approximately 24 weeks. 


End point title 
Absolute Change From Baseline in LDLc Concentration at Day 169  
End point description 
Modified Intent to Treat (mITT) population included participants who were randomized and received at least 1 dose of study drug. Participants with baseline measurement and post baseline measurement of LDLc concentration at Day 169 were included in the analysis of this end point.


End point type 
Primary


End point timeframe 
Baseline, Day 169




Notes [1]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. [2]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. [3]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. [4]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. [5]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. [6]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. 

Statistical analysis title 
Statistical analysis I  
Statistical analysis description 
This analysis was performed on Day 169. Least squares (LS) mean difference, 95% confidence intervals (CIs) and p−values were based on an analysis of covariance model adjusted for baseline LDLc (less than [<] 120 mg/dL, greater than or equal to [≥] 120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=104.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
104


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
61.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
51.7  
upper limit 
71.9  
Variability estimate 
Standard error of the mean


Dispersion value 
5.1


Statistical analysis title 
Statistical analysis II  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
80


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.7885  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
1.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11.1  
upper limit 
14.6  
Variability estimate 
Standard error of the mean


Dispersion value 
6.5


Statistical analysis title 
Statistical analysis III  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=87.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
87


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0005  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
21


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.3  
upper limit 
32.7  
Variability estimate 
Standard error of the mean


Dispersion value 
5.9


Statistical analysis title 
Statistical analysis IV  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
103


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
43.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
33.3  
upper limit 
53.6  
Variability estimate 
Standard error of the mean


Dispersion value 
5.2


Statistical analysis title 
Statistical analysis V  
Statistical analysis description 
Differences from Pbo are the difference between LS means with the standard error. P−values are adjusted for baseline LDLc (<120 mg/dL, >=120 mg/dL) and diabetes status (yes,no) and not adjusted for multiple testing. Number of subjects included in analysis=78.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
78


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0579  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
12.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.4  
upper limit 
26.2  
Variability estimate 
Standard error of the mean


Dispersion value 
6.8



End point title 
Absolute Change From Baseline in LDLc Concentration for Each Arm at the Nadir for That Arm  
End point description 
Nadir is defined as the planned visit, up to day 169, with the greatest mean decrease within a treatment group. mITT population participants with baseline measurement and at least 1 postbaseline measurement of LDLc concentration were included in the analysis of this end point.


End point type 
Secondary


End point timeframe 
Baseline, up to Day 169 (Nadir)




Notes [7]  Includes participants who were evaluable with nonmissing LDLc values at baseline and up to Day 169. [8]  Includes participants who were evaluable with nonmissing LDLc values at baseline and up to Day 169. [9]  Includes participants who were evaluable with nonmissing LDLc values at baseline and up to Day 169. [10]  Includes participants who were evaluable with nonmissing LDLc values at baseline and up to Day 169. [11]  Includes participants who were evaluable with nonmissing LDLc values at baseline and up to Day 169. [12]  Includes participants who were evaluable with nonmissing LDLc values at baseline and up to Day 169. 

Statistical analysis title 
Statistical analysis I  
Statistical analysis description 
This analysis was performed at nadir timepoint. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=111.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
111


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
72.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
64  
upper limit 
81.3  
Variability estimate 
Standard error of the mean


Dispersion value 
4.4


Statistical analysis title 
Statistical analysis II  
Statistical analysis description 
This analysis was performed at nadir timepoint. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
81


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
55.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
44.4  
upper limit 
67.4  
Variability estimate 
Standard error of the mean


Dispersion value 
5.8


Statistical analysis title 
Statistical analysis III  
Statistical analysis description 
This analysis was performed at nadir timepoint. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=88.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
88


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
67.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
57.1  
upper limit 
77.9  
Variability estimate 
Standard error of the mean


Dispersion value 
5.3


Statistical analysis title 
Statistical analysis IV  
Statistical analysis description 
This analysis was performed at nadir timepoint. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
107


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
70.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
61.8  
upper limit 
79.4  
Variability estimate 
Standard error of the mean


Dispersion value 
4.5


Statistical analysis title 
Statistical analysis V  
Statistical analysis description 
This analysis was performed at nadir timepoint. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
83


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
73.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
62.8  
upper limit 
85  
Variability estimate 
Standard error of the mean


Dispersion value 
5.6



End point title 
Average Change from Baseline in LDLc Concentration Weighted By the Number of Weeks Between Consecutive LDLc Measurements at Day 169  
End point description 
This outcome was calculated by dividing the average change from baseline of LDLc concentration by average number of weeks of study treatment. mITTpopulation participants with baseline and post baseline measurement of LDLc concentration at Day 169 were included in the analysis of this end point.


End point type 
Secondary


End point timeframe 
Baseline, Day 169




Notes [13]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. [14]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. [15]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. [16]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. [17]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. [18]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. 

Statistical analysis title 
Statistical analysis I  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
103


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
68.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
61.1  
upper limit 
76  
Variability estimate 
Standard error of the mean


Dispersion value 
3.8


Statistical analysis title 
Statistical analysis II  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
80


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
25.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
16  
upper limit 
34.9  
Variability estimate 
Standard error of the mean


Dispersion value 
4.8


Statistical analysis title 
Statistical analysis III  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=87.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
87


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
48.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
40.2  
upper limit 
57.3  
Variability estimate 
Standard error of the mean


Dispersion value 
4.4


Statistical analysis title 
Statistical analysis IV  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=102.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
102


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
62.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
54.7  
upper limit 
69.7  
Variability estimate 
Standard error of the mean


Dispersion value 
3.8


Statistical analysis title 
Statistical analysis V  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=78.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
78


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
51.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
41.9  
upper limit 
61.5  
Variability estimate 
Standard error of the mean


Dispersion value 
5



End point title 
Average Percentage Change from Baseline in LDLc Concentration Weighted By the Number of Weeks Between Consecutive LDLc Measurements at Day 169  
End point description 
mITT population participants with baseline and post baseline measurement of LDLc concentration at Day 169 were included in the analysis of this end point.


End point type 
Secondary


End point timeframe 
Baseline, Day 169




Notes [19]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. [20]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. [21]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. [22]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. [23]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. [24]  Includes participants who were evaluable with nonmissing LDLc values at baseline and Day 169. 

Statistical analysis title 
Statistical analysis I  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
103


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
56.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
51.1  
upper limit 
62  
Variability estimate 
Standard error of the mean


Dispersion value 
2.8


Statistical analysis title 
Statistical analysis II  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
80


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
22


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
15.1  
upper limit 
28.9  
Variability estimate 
Standard error of the mean


Dispersion value 
3.5


Statistical analysis title 
Statistical analysis III  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=87.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
87


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
38.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
32.2  
upper limit 
44.8  
Variability estimate 
Standard error of the mean


Dispersion value 
3.2


Statistical analysis title 
Statistical analysis IV  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=102.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
102


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
52.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
46.6  
upper limit 
57.6  
Variability estimate 
Standard error of the mean


Dispersion value 
2.8


Statistical analysis title 
Statistical analysis V  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=78.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
78


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
41.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
34.4  
upper limit 
48.8  
Variability estimate 
Standard error of the mean


Dispersion value 
3.6



End point title 
Percentage Change from Baseline in LDLc Concentration for Each Arm at Day 169 and at the Nadir for That Arm  
End point description 
Nadir is defined as the planned visit, up to day 169, with the greatest mean decrease within a treatment group. mITT population participants with baseline and post baseline measurement of LDLc concentration at Day 169 were included in the analysis of this end point. "n" value indicates the number of participants evaluable at a specified timepoint for a particular treatment arm.


End point type 
Secondary


End point timeframe 
Baseline, Day 169, up to Day 169 (Nadir)




Notes [25]  n=45 on Day 169 and n=50 at nadir. [26]  n=21 on Day 169 and n=20 at nadir. [27]  n=28 on Day 169 and n=27 at nadir. [28]  n=44 on Day 169 and n=46 at nadir. [29]  n=19 on Day 169 and n=22 at nadir. [30]  n=59 on Day 169 and n=61 at nadir. 

Statistical analysis title 
Statistical analysis I  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and pvalues were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=104.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
111


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
51


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
43.5  
upper limit 
58.5  
Variability estimate 
Standard error of the mean


Dispersion value 
3.8


Statistical analysis title 
Statistical analysis II  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and pvalues were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
82


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.6097  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
2.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
7.1  
upper limit 
12.1  
Variability estimate 
Standard error of the mean


Dispersion value 
4.9


Statistical analysis title 
Statistical analysis III  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and pvalues were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=87.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
89


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0007  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
15.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
6.4  
upper limit 
23.9  
Variability estimate 
Standard error of the mean


Dispersion value 
4.4


Statistical analysis title 
Statistical analysis IV  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and pvalues were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
107


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
36.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
28.6  
upper limit 
43.8  
Variability estimate 
Standard error of the mean


Dispersion value 
3.8


Statistical analysis title 
Statistical analysis V  
Statistical analysis description 
This analysis was performed on Day 169. LS mean difference, 95% CIs and pvalues were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=78.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
83


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.1027  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
8.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.7  
upper limit 
18.2  
Variability estimate 
Standard error of the mean


Dispersion value 
5


Statistical analysis title 
Statistical analysis VI  
Statistical analysis description 
This analysis was performed at Nadir timepoint. LS mean difference, 95% CIs and pvalues were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=111.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
111


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
59.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
53.5  
upper limit 
66  
Variability estimate 
Standard error of the mean


Dispersion value 
3.2


Statistical analysis title 
Statistical analysis VII  
Statistical analysis description 
This analysis was performed at Nadir timepoint. LS mean difference, 95% CIs and pvalues were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.


Comparison groups 
MPSK3169A 200 mg Q8W v Placebo


Number of subjects included in analysis 
82


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
48.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
39.9  
upper limit 
56.5  
Variability estimate 
Standard error of the mean


Dispersion value 
4.2


Statistical analysis title 
Statistical analysis VIII  
Statistical analysis description 
This analysis was performed at Nadir timepoint. LS mean difference, 95% CIs and pvalues were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=88.


Comparison groups 
MPSK3169A 400 mg Q8W v Placebo


Number of subjects included in analysis 
89


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
54.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
46.9  
upper limit 
61.9  
Variability estimate 
Standard error of the mean


Dispersion value 
3.8


Statistical analysis title 
Statistical analysis IX  
Statistical analysis description 
This analysis was performed at Nadir timepoint. LS mean difference, 95% CIs and pvalues were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.


Comparison groups 
MPSK3169A 800 mg Q8W v Placebo


Number of subjects included in analysis 
107


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
58.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
52.4  
upper limit 
65.1  
Variability estimate 
Standard error of the mean


Dispersion value 
3.2


Statistical analysis title 
Statistical analysis X  
Statistical analysis description 
This analysis was performed at Nadir timepoint. LS mean difference, 95% CIs and pvalues were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.


Comparison groups 
MPSK3169A 800 mg Q12W v Placebo


Number of subjects included in analysis 
83


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
56.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
48.5  
upper limit 
64.6  
Variability estimate 
Standard error of the mean


Dispersion value 
4.1



End point title 
Absolute Change From Baseline (CFB) in LDLc Concentration at all Other TimePoints  
End point description 
mITT population participants with baseline and at least 1 post baseline measurement of LDLc concentration were included in the analysis of this end point. "n" value indicates the number of participants evaluable at a specified timepoint for a particular treatment arm.


End point type 
Secondary


End point timeframe 
Baseline, Days 8, 15, 22, 29, 43, 57, 71, 85, 99, 113, 120, 141, and 155




Statistical analysis title 
Statistical analysis 1  
Statistical analysis description 
This analysis was performed on Day 8. LS mean difference, 95% CIs and pvalues were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=110.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
54.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
46.8  
upper limit 
61.7  
Variability estimate 
Standard error of the mean


Dispersion value 
3.8


Statistical analysis title 
Statistical analysis 2  
Statistical analysis description 
This analysis was performed on Day 8. LS mean difference, 95% CIs and pvalues were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
51.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
42.1  
upper limit 
60.7  
Variability estimate 
Standard error of the mean


Dispersion value 
4.7


Statistical analysis title 
Statistical analysis 3  
Statistical analysis description 
This analysis was performed on Day 8. LS mean difference, 95% CIs and pvalues were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
57.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
48.1  
upper limit 
66.4  
Variability estimate 
Standard error of the mean


Dispersion value 
4.6


Statistical analysis title 
Statistical analysis 4  
Statistical analysis description 
This analysis was performed on Day 8. LS mean difference, 95% CIs and pvalues were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
56.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
48.6  
upper limit 
63.9  
Variability estimate 
Standard error of the mean


Dispersion value 
3.9


Statistical analysis title 
Statistical analysis 5  
Statistical analysis description 
This analysis was performed on Day 8. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=82.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
56.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
46.7  
upper limit 
65.7  
Variability estimate 
Standard error of the mean


Dispersion value 
4.8


Statistical analysis title 
Statistical analysis 6  
Statistical analysis description 
This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=111.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
65.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
57.4  
upper limit 
74.1  
Variability estimate 
Standard error of the mean


Dispersion value 
4.2


Statistical analysis title 
Statistical analysis 7  
Statistical analysis description 
This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.


Comparison groups 
MPSK3169A 200 mg Q8W v Placebo


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
53


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
42.4  
upper limit 
63.5  
Variability estimate 
Standard error of the mean


Dispersion value 
5.3


Statistical analysis title 
Statistical analysis 8  
Statistical analysis description 
This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.


Comparison groups 
MPSK3169A 400 mg Q8W v Placebo


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
64.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
55  
upper limit 
74.8  
Variability estimate 
Standard error of the mean


Dispersion value 
5


Statistical analysis title 
Statistical analysis 9  
Statistical analysis description 
This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
69


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
60.4  
upper limit 
77.5  
Variability estimate 
Standard error of the mean


Dispersion value 
4.3


Statistical analysis title 
Statistical analysis 10  
Statistical analysis description 
This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.


Comparison groups 
MPSK3169A 800 mg Q12W v Placebo


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
66.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
55.7  
upper limit 
77.9  
Variability estimate 
Standard error of the mean


Dispersion value 
5.6


Statistical analysis title 
Statistical analysis 11  
Statistical analysis description 
This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=108.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
70.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
62.2  
upper limit 
79.5  
Variability estimate 
Standard error of the mean


Dispersion value 
4.4


Statistical analysis title 
Statistical analysis 12  
Statistical analysis description 
This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.


Comparison groups 
MPSK3169A 200 mg Q8W v Placebo


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
51.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
40.5  
upper limit 
62.1  
Variability estimate 
Standard error of the mean


Dispersion value 
5.5


Statistical analysis title 
Statistical analysis 13  
Statistical analysis description 
This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
71


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
60.9  
upper limit 
81.1  
Variability estimate 
Standard error of the mean


Dispersion value 
5.1


Statistical analysis title 
Statistical analysis 14  
Statistical analysis description 
This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=108.


Comparison groups 
MPSK3169A 800 mg Q8W v Placebo


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
73.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
64.6  
upper limit 
81.8  
Variability estimate 
Standard error of the mean


Dispersion value 
4.4


Statistical analysis title 
Statistical analysis 15  
Statistical analysis description 
This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.


Comparison groups 
MPSK3169A 800 mg Q12W v Placebo


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
72.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
61.8  
upper limit 
83.5  
Variability estimate 
Standard error of the mean


Dispersion value 
5.5


Statistical analysis title 
Statistical analysis 16  
Statistical analysis description 
This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=112.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
67.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
58.1  
upper limit 
76.3  
Variability estimate 
Standard error of the mean


Dispersion value 
4.6


Statistical analysis title 
Statistical analysis 17  
Statistical analysis description 
This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=86.


Comparison groups 
MPSK3169A 200 mg Q8W v Placebo


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
36.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
24.7  
upper limit 
47.7  
Variability estimate 
Standard error of the mean


Dispersion value 
5.8


Statistical analysis title 
Statistical analysis 18  
Statistical analysis description 
This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=91.


Comparison groups 
MPSK3169A 400 mg Q8W v Placebo


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
66.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
55.3  
upper limit 
76.9  
Variability estimate 
Standard error of the mean


Dispersion value 
5.5


Statistical analysis title 
Statistical analysis 19  
Statistical analysis description 
This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=112.


Comparison groups 
MPSK3169A 800 mg Q8W v Placebo


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
73.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
64.6  
upper limit 
82.7  
Variability estimate 
Standard error of the mean


Dispersion value 
4.6


Statistical analysis title 
Statistical analysis 20  
Statistical analysis description 
This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.


Comparison groups 
MPSK3169A 800 mg Q12W v Placebo


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
76.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
64.5  
upper limit 
88.4  
Variability estimate 
Standard error of the mean


Dispersion value 
6.1


Statistical analysis title 
Statistical analysis 21  
Statistical analysis description 
This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=111.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
78.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
68.8  
upper limit 
87.7  
Variability estimate 
Standard error of the mean


Dispersion value 
4.8


Statistical analysis title 
Statistical analysis 22  
Statistical analysis description 
This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.


Comparison groups 
MPSK3169A 200 mg Q8W v Placebo


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0017  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
15.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.5  
upper limit 
27.7  
Variability estimate 
Standard error of the mean


Dispersion value 
6.1


Statistical analysis title 
Statistical analysis 23  
Statistical analysis description 
This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=87.


Comparison groups 
MPSK3169A 400 mg Q8W v Placebo


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
53.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
41.7  
upper limit 
64.8  
Variability estimate 
Standard error of the mean


Dispersion value 
5.9


Statistical analysis title 
Statistical analysis 24  
Statistical analysis description 
This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.


Comparison groups 
MPSK3169A 800 mg Q8W v Placebo


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
64.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
55.1  
upper limit 
74.3  
Variability estimate 
Standard error of the mean


Dispersion value 
4.9


Statistical analysis title 
Statistical analysis 25  
Statistical analysis description 
This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.


Comparison groups 
MPSK3169A 800 mg Q12W v Placebo


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
66.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
54.4  
upper limit 
78.3  
Variability estimate 
Standard error of the mean


Dispersion value 
6.1


Statistical analysis title 
Statistical analysis 26  
Statistical analysis description 
This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=111.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
71.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
62.1  
upper limit 
81.2  
Variability estimate 
Standard error of the mean


Dispersion value 
4.8


Statistical analysis title 
Statistical analysis 27  
Statistical analysis description 
This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.


Comparison groups 
MPSK3169A 200 mg Q8W v Placebo


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.2596  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5.2  
upper limit 
19.2  
Variability estimate 
Standard error of the mean


Dispersion value 
6.2


Statistical analysis title 
Statistical analysis 28  
Statistical analysis description 
This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=86.


Comparison groups 
MPSK3169A 400 mg Q8W v Placebo


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
27.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
16.3  
upper limit 
39.3  
Variability estimate 
Standard error of the mean


Dispersion value 
5.8


Statistical analysis title 
Statistical analysis 29  
Statistical analysis description 
This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=106.


Comparison groups 
MPSK3169A 800 mg Q8W v Placebo


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
52.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
42.5  
upper limit 
62  
Variability estimate 
Standard error of the mean


Dispersion value 
4.9


Statistical analysis title 
Statistical analysis 30  
Statistical analysis description 
This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.


Comparison groups 
MPSK3169A 800 mg Q12W v Placebo


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
61.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
49.2  
upper limit 
74.1  
Variability estimate 
Standard error of the mean


Dispersion value 
6.3


Statistical analysis title 
Statistical analysis 31  
Statistical analysis description 
This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=112.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
74


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
65.1  
upper limit 
82.9  
Variability estimate 
Standard error of the mean


Dispersion value 
4.5


Statistical analysis title 
Statistical analysis 32  
Statistical analysis description 
This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=79.


Comparison groups 
MPSK3169A 200 mg Q8W v Placebo


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
58.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
46.7  
upper limit 
70.8  
Variability estimate 
Standard error of the mean


Dispersion value 
6.1


Statistical analysis title 
Statistical analysis 33  
Statistical analysis description 
This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=86.


Comparison groups 
MPSK3169A 400 mg Q8W v Placebo


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
70.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
59.7  
upper limit 
81.5  
Variability estimate 
Standard error of the mean


Dispersion value 
5.5


Statistical analysis title 
Statistical analysis 34  
Statistical analysis description 
This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.


Comparison groups 
MPSK3169A 800 mg Q8W v Placebo


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
73.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
64.4  
upper limit 
82.9  
Variability estimate 
Standard error of the mean


Dispersion value 
4.7


Statistical analysis title 
Statistical analysis 35  
Statistical analysis description 
This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.


Comparison groups 
MPSK3169A 800 mg Q12W v Placebo


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
29.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
17.5  
upper limit 
40.8  
Variability estimate 
Standard error of the mean


Dispersion value 
5.9


Statistical analysis title 
Statistical analysis 36  
Statistical analysis description 
This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=114.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
62.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
52.8  
upper limit 
72  
Variability estimate 
Standard error of the mean


Dispersion value 
4.9


Statistical analysis title 
Statistical analysis 37  
Statistical analysis description 
This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.


Comparison groups 
MPSK3169A 200 mg Q8W v Placebo


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
37.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
25.3  
upper limit 
50.1  
Variability estimate 
Standard error of the mean


Dispersion value 
6.3


Statistical analysis title 
Statistical analysis 38  
Statistical analysis description 
This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.


Comparison groups 
MPSK3169A 400 mg Q8W v Placebo


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
58.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
47.1  
upper limit 
70.4  
Variability estimate 
Standard error of the mean


Dispersion value 
5.9


Statistical analysis title 
Statistical analysis 39  
Statistical analysis description 
This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=108.


Comparison groups 
MPSK3169A 800 mg Q8W v Placebo


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
67.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
57.3  
upper limit 
77.2  
Variability estimate 
Standard error of the mean


Dispersion value 
5


Statistical analysis title 
Statistical analysis 40  
Statistical analysis description 
This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.


Comparison groups 
MPSK3169A 800 mg Q12W v Placebo


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0795  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
11.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.3  
upper limit 
23.9  
Variability estimate 
Standard error of the mean


Dispersion value 
6.4


Statistical analysis title 
Statistical analysis 41  
Statistical analysis description 
This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
72.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
62.9  
upper limit 
81.4  
Variability estimate 
Standard error of the mean


Dispersion value 
4.7


Statistical analysis title 
Statistical analysis 42  
Statistical analysis description 
This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.048  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
11.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.1  
upper limit 
23.5  
Variability estimate 
Standard error of the mean


Dispersion value 
5.9


Statistical analysis title 
Statistical analysis 43  
Statistical analysis description 
This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
46.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
35.7  
upper limit 
57.8  
Variability estimate 
Standard error of the mean


Dispersion value 
5.9


Statistical analysis title 
Statistical analysis 44  
Statistical analysis description 
This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=101.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
60.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
50.7  
upper limit 
69.9  
Variability estimate 
Standard error of the mean


Dispersion value 
4.9


Statistical analysis title 
Statistical analysis 45  
Statistical analysis description 
This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=77.


Comparison groups 
MPSK3169A 800 mg Q12W v Placebo


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
77


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
64.7  
upper limit 
89.3  
Variability estimate 
Standard error of the mean


Dispersion value 
6.2


Statistical analysis title 
Statistical analysis 46  
Statistical analysis description 
This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=106.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
64.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
54.5  
upper limit 
75  
Variability estimate 
Standard error of the mean


Dispersion value 
5.2


Statistical analysis title 
Statistical analysis 47  
Statistical analysis description 
This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.5761  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
3.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.2  
upper limit 
16.5  
Variability estimate 
Standard error of the mean


Dispersion value 
6.5


Statistical analysis title 
Statistical analysis 48  
Statistical analysis description 
This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0002  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
23.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11.3  
upper limit 
35.8  
Variability estimate 
Standard error of the mean


Dispersion value 
6.2


Statistical analysis title 
Statistical analysis 49  
Statistical analysis description 
This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
42.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
32.4  
upper limit 
53.4  
Variability estimate 
Standard error of the mean


Dispersion value 
5.3


Statistical analysis title 
Statistical analysis 50  
Statistical analysis description 
This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
76.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
63.3  
upper limit 
89.5  
Variability estimate 
Standard error of the mean


Dispersion value 
6.6


Statistical analysis title 
Statistical analysis 51  
Statistical analysis description 
This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
71.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
62.3  
upper limit 
80.8  
Variability estimate 
Standard error of the mean


Dispersion value 
4.7


Statistical analysis title 
Statistical analysis 52  
Statistical analysis description 
This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
50.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
38.5  
upper limit 
61.6  
Variability estimate 
Standard error of the mean


Dispersion value 
5.8


Statistical analysis title 
Statistical analysis 53  
Statistical analysis description 
This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
60.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
49.4  
upper limit 
71.4  
Variability estimate 
Standard error of the mean


Dispersion value 
5.6


Statistical analysis title 
Statistical analysis 54  
Statistical analysis description 
This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=102.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
68.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
59.1  
upper limit 
78.1  
Variability estimate 
Standard error of the mean


Dispersion value 
4.8


Statistical analysis title 
Statistical analysis 55  
Statistical analysis description 
This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
74.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
63.2  
upper limit 
86.6  
Variability estimate 
Standard error of the mean


Dispersion value 
6


Statistical analysis title 
Statistical analysis 56  
Statistical analysis description 
This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
61.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
52.4  
upper limit 
70.8  
Variability estimate 
Standard error of the mean


Dispersion value 
4.7


Statistical analysis title 
Statistical analysis 57  
Statistical analysis description 
This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=79.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
34.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
23  
upper limit 
46.2  
Variability estimate 
Standard error of the mean


Dispersion value 
5.9


Statistical analysis title 
Statistical analysis 58  
Statistical analysis description 
This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
60.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
50.1  
upper limit 
71.8  
Variability estimate 
Standard error of the mean


Dispersion value 
5.5


Statistical analysis title 
Statistical analysis 59  
Statistical analysis description 
This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
67.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
58.6  
upper limit 
77.2  
Variability estimate 
Standard error of the mean


Dispersion value 
4.7


Statistical analysis title 
Statistical analysis 60  
Statistical analysis description 
This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=78.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
55.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
43.7  
upper limit 
67.3  
Variability estimate 
Standard error of the mean


Dispersion value 
6


Statistical analysis title 
Statistical analysis 61  
Statistical analysis description 
This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
65.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
56.8  
upper limit 
74.8  
Variability estimate 
Standard error of the mean


Dispersion value 
4.6


Statistical analysis title 
Statistical analysis 62  
Statistical analysis description 
This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.1512  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
8.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.1  
upper limit 
19.6  
Variability estimate 
Standard error of the mean


Dispersion value 
5.7


Statistical analysis title 
Statistical analysis 63  
Statistical analysis description 
This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=86.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
40


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
29.5  
upper limit 
50.5  
Variability estimate 
Standard error of the mean


Dispersion value 
5.3


Statistical analysis title 
Statistical analysis 64  
Statistical analysis description 
This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=100.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
60.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
51.3  
upper limit 
69.8  
Variability estimate 
Standard error of the mean


Dispersion value 
4.7


Statistical analysis title 
Statistical analysis 65  
Statistical analysis description 
This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
29.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
18.2  
upper limit 
40.9  
Variability estimate 
Standard error of the mean


Dispersion value 
5.8



End point title 
Percentage Change From Baseline (%CFB) in LDLc Concentration at all Other Time Points  
End point description 
mITT population participants with baseline and at least 1 post baseline measurement of LDLc concentration were included in the analysis of this end point. “n” value indicates the number of participants evaluable at a specified timepoint for a particular treatment arm.


End point type 
Secondary


End point timeframe 
Baseline, Days 8, 15, 22, 29, 43, 57, 71, 85, 99, 113, 120, 141, and 155




Statistical analysis title 
Statistical analysis 1  
Statistical analysis description 
This analysis was performed on Day 8. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=110.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
47.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
41  
upper limit 
54  
Variability estimate 
Standard error of the mean


Dispersion value 
3.3


Statistical analysis title 
Statistical analysis 2  
Statistical analysis description 
This analysis was performed on Day 8. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
45.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
36.9  
upper limit 
53.3  
Variability estimate 
Standard error of the mean


Dispersion value 
4.1


Statistical analysis title 
Statistical analysis 3  
Statistical analysis description 
This analysis was performed on Day 8. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
46


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
38  
upper limit 
54  
Variability estimate 
Standard error of the mean


Dispersion value 
4.1


Statistical analysis title 
Statistical analysis 4  
Statistical analysis description 
This analysis was performed on Day 8. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.


Comparison groups 
MPSK3169A 800 mg Q8W v Placebo


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
48.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
41.5  
upper limit 
55  
Variability estimate 
Standard error of the mean


Dispersion value 
3.4


Statistical analysis title 
Statistical analysis 5  
Statistical analysis description 
This analysis was performed on Day 8. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=82.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
45.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
37.4  
upper limit 
54.1  
Variability estimate 
Standard error of the mean


Dispersion value 
4.2


Statistical analysis title 
Statistical analysis 6  
Statistical analysis description 
This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=111.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
55.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
49.4  
upper limit 
62.3  
Variability estimate 
Standard error of the mean


Dispersion value 
3.3


Statistical analysis title 
Statistical analysis 7  
Statistical analysis description 
This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
45.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
37.4  
upper limit 
53.8  
Variability estimate 
Standard error of the mean


Dispersion value 
4.2


Statistical analysis title 
Statistical analysis 8  
Statistical analysis description 
This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
51.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
43.7  
upper limit 
59.2  
Variability estimate 
Standard error of the mean


Dispersion value 
3.9


Statistical analysis title 
Statistical analysis 9  
Statistical analysis description 
This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
58.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
51.5  
upper limit 
64.9  
Variability estimate 
Standard error of the mean


Dispersion value 
3.4


Statistical analysis title 
Statistical analysis 10  
Statistical analysis description 
This analysis was performed on Day 15. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
53.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
44.5  
upper limit 
61.9  
Variability estimate 
Standard error of the mean


Dispersion value 
4.4


Statistical analysis title 
Statistical analysis 11  
Statistical analysis description 
This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=108.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
59


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
52.7  
upper limit 
65.3  
Variability estimate 
Standard error of the mean


Dispersion value 
3.2


Statistical analysis title 
Statistical analysis 12  
Statistical analysis description 
This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
44.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
36.4  
upper limit 
52.2  
Variability estimate 
Standard error of the mean


Dispersion value 
4


Statistical analysis title 
Statistical analysis 13  
Statistical analysis description 
This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
55.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
48  
upper limit 
62.8  
Variability estimate 
Standard error of the mean


Dispersion value 
3.8


Statistical analysis title 
Statistical analysis 14  
Statistical analysis description 
This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=108.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
61.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
55.2  
upper limit 
67.8  
Variability estimate 
Standard error of the mean


Dispersion value 
3.2


Statistical analysis title 
Statistical analysis 15  
Statistical analysis description 
This analysis was performed on Day 22. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
57.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
49.2  
upper limit 
65.1  
Variability estimate 
Standard error of the mean


Dispersion value 
4


Statistical analysis title 
Statistical analysis 16  
Statistical analysis description 
This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=112.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
54.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
47.8  
upper limit 
61  
Variability estimate 
Standard error of the mean


Dispersion value 
3.3


Statistical analysis title 
Statistical analysis 17  
Statistical analysis description 
This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=86.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
30.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
22.5  
upper limit 
39.2  
Variability estimate 
Standard error of the mean


Dispersion value 
4.2


Statistical analysis title 
Statistical analysis 18  
Statistical analysis description 
Statistical analysis 18
This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). ). Number of subjects included in analysis=91.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
51


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
43.2  
upper limit 
58.8  
Variability estimate 
Standard error of the mean


Dispersion value 
4


Statistical analysis title 
Statistical analysis 19  
Statistical analysis description 
This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=112.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
60.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
54.1  
upper limit 
67.3  
Variability estimate 
Standard error of the mean


Dispersion value 
3.3


Statistical analysis title 
Statistical analysis 20  
Statistical analysis description 
This analysis was performed on Day 29. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
58.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
50.1  
upper limit 
67.5  
Variability estimate 
Standard error of the mean


Dispersion value 
4.4


Statistical analysis title 
Statistical analysis 21  
Statistical analysis description 
This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=111.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
63.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
57.2  
upper limit 
70.5  
Variability estimate 
Standard error of the mean


Dispersion value 
3.4


Statistical analysis title 
Statistical analysis 22  
Statistical analysis description 
This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0019  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
13.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5.1  
upper limit 
22.2  
Variability estimate 
Standard error of the mean


Dispersion value 
4.3


Statistical analysis title 
Statistical analysis 23  
Statistical analysis description 
This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=87.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
39.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
31.6  
upper limit 
47.9  
Variability estimate 
Standard error of the mean


Dispersion value 
4.1


Statistical analysis title 
Statistical analysis 24  
Statistical analysis description 
This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
53.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
46.7  
upper limit 
60.3  
Variability estimate 
Standard error of the mean


Dispersion value 
3.4


Statistical analysis title 
Statistical analysis 25  
Statistical analysis description 
This analysis was performed on Day 43. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
51.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
42.6  
upper limit 
59.6  
Variability estimate 
Standard error of the mean


Dispersion value 
4.3


Statistical analysis title 
Statistical analysis 26  
Statistical analysis description 
This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=111.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
59.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
52.1  
upper limit 
66.6  
Variability estimate 
Standard error of the mean


Dispersion value 
3.7


Statistical analysis title 
Statistical analysis 27  
Statistical analysis description 
This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.1812  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
6.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.9  
upper limit 
15.5  
Variability estimate 
Standard error of the mean


Dispersion value 
4.7


Statistical analysis title 
Statistical analysis 28  
Statistical analysis description 
This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=86.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
21.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
12.6  
upper limit 
30  
Variability estimate 
Standard error of the mean


Dispersion value 
4.4


Statistical analysis title 
Statistical analysis 29  
Statistical analysis description 
This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=106.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
44.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
37.1  
upper limit 
51.8  
Variability estimate 
Standard error of the mean


Dispersion value 
3.7


Statistical analysis title 
Statistical analysis 30  
Statistical analysis description 
This analysis was performed on Day 57. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
48.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
39  
upper limit 
57.8  
Variability estimate 
Standard error of the mean


Dispersion value 
4.8


Statistical analysis title 
Statistical analysis 31  
Statistical analysis description 
This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=112.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
62.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
55.8  
upper limit 
69  
Variability estimate 
Standard error of the mean


Dispersion value 
3.3


Statistical analysis title 
Statistical analysis 32  
Statistical analysis description 
This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=79.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
51.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
42.2  
upper limit 
60  
Variability estimate 
Standard error of the mean


Dispersion value 
4.5


Statistical analysis title 
Statistical analysis 33  
Statistical analysis description 
This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=86.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
57.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
49.2  
upper limit 
65.3  
Variability estimate 
Standard error of the mean


Dispersion value 
4.1


Statistical analysis title 
Statistical analysis 34  
Statistical analysis description 
This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
61.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
54.8  
upper limit 
68.5  
Variability estimate 
Standard error of the mean


Dispersion value 
3.5


Statistical analysis title 
Statistical analysis 35  
Statistical analysis description 
This analysis was performed on Day 71. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
22.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
14.2  
upper limit 
31.5  
Variability estimate 
Standard error of the mean


Dispersion value 
4.4


Statistical analysis title 
Statistical analysis 36  
Statistical analysis description 
This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=114.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
51.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
44  
upper limit 
58.5  
Variability estimate 
Standard error of the mean


Dispersion value 
3.7


Statistical analysis title 
Statistical analysis 37  
Statistical analysis description 
This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
32.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
23.3  
upper limit 
42  
Variability estimate 
Standard error of the mean


Dispersion value 
4.8


Statistical analysis title 
Statistical analysis 38  
Statistical analysis description 
This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
45.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
37.1  
upper limit 
54.7  
Variability estimate 
Standard error of the mean


Dispersion value 
4.5


Statistical analysis title 
Statistical analysis 39  
Statistical analysis description 
This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=108.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
55.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
48.3  
upper limit 
63.3  
Variability estimate 
Standard error of the mean


Dispersion value 
3.8


Statistical analysis title 
Statistical analysis 40  
Statistical analysis description 
This analysis was performed on Day 85. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.1312  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
7.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.2  
upper limit 
16.9  
Variability estimate 
Standard error of the mean


Dispersion value 
4.8


Statistical analysis title 
Statistical analysis 41  
Statistical analysis description 
This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
61.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
53.9  
upper limit 
68.3  
Variability estimate 
Standard error of the mean


Dispersion value 
3.7


Statistical analysis title 
Statistical analysis 42  
Statistical analysis description 
This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0115  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
11.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.7  
upper limit 
20.9  
Variability estimate 
Standard error of the mean


Dispersion value 
4.6


Statistical analysis title 
Statistical analysis 43  
Statistical analysis description 
This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
38.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
29.8  
upper limit 
47  
Variability estimate 
Standard error of the mean


Dispersion value 
4.4


Statistical analysis title 
Statistical analysis 44  
Statistical analysis description 
This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=101.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
52


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
44.4  
upper limit 
59.5  
Variability estimate 
Standard error of the mean


Dispersion value 
3.8


Statistical analysis title 
Statistical analysis 45  
Statistical analysis description 
This analysis was performed on Day 99. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=77.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
61.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
51.7  
upper limit 
70.9  
Variability estimate 
Standard error of the mean


Dispersion value 
4.9


Statistical analysis title 
Statistical analysis 46  
Statistical analysis description 
This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
54.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
46.7  
upper limit 
61.6  
Variability estimate 
Standard error of the mean


Dispersion value 
3.8


Statistical analysis title 
Statistical analysis 47  
Statistical analysis description 
This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.4651  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
3.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5.9  
upper limit 
12.8  
Variability estimate 
Standard error of the mean


Dispersion value 
4.7


Statistical analysis title 
Statistical analysis 48  
Statistical analysis description 
This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
17.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
8.9  
upper limit 
26.7  
Variability estimate 
Standard error of the mean


Dispersion value 
4.5


Statistical analysis title 
Statistical analysis 49  
Statistical analysis description 
This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
37.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
30  
upper limit 
45.2  
Variability estimate 
Standard error of the mean


Dispersion value 
3.9


Statistical analysis title 
Statistical analysis 50  
Statistical analysis description 
This analysis was performed on Day 113. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
58.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
49.1  
upper limit 
68  
Variability estimate 
Standard error of the mean


Dispersion value 
4.8


Statistical analysis title 
Statistical analysis 51  
Statistical analysis description 
This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
60.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
53.4  
upper limit 
67.2  
Variability estimate 
Standard error of the mean


Dispersion value 
3.5


Statistical analysis title 
Statistical analysis 52  
Statistical analysis description 
This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
43.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
34.8  
upper limit 
51.9  
Variability estimate 
Standard error of the mean


Dispersion value 
4.3


Statistical analysis title 
Statistical analysis 53  
Statistical analysis description 
This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
50.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
42.2  
upper limit 
58.5  
Variability estimate 
Standard error of the mean


Dispersion value 
4.1


Statistical analysis title 
Statistical analysis 54  
Statistical analysis description 
This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=102.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
59.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
52.4  
upper limit 
66.4  
Variability estimate 
Standard error of the mean


Dispersion value 
3.6


Statistical analysis title 
Statistical analysis 55  
Statistical analysis description 
This analysis was performed on Day 120. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
57.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
49.1  
upper limit 
66.6  
Variability estimate 
Standard error of the mean


Dispersion value 
4.4


Statistical analysis title 
Statistical analysis 56  
Statistical analysis description 
This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
50.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
43.8  
upper limit 
58.1  
Variability estimate 
Standard error of the mean


Dispersion value 
3.6


Statistical analysis title 
Statistical analysis 57  
Statistical analysis description 
This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=79.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
28.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
19.9  
upper limit 
38  
Variability estimate 
Standard error of the mean


Dispersion value 
4.6


Statistical analysis title 
Statistical analysis 58  
Statistical analysis description 
This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=84.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
49.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
40.8  
upper limit 
57.8  
Variability estimate 
Standard error of the mean


Dispersion value 
4.3


Statistical analysis title 
Statistical analysis 59  
Statistical analysis description 
This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=103.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
56.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
49.4  
upper limit 
63.9  
Variability estimate 
Standard error of the mean


Dispersion value 
3.7


Statistical analysis title 
Statistical analysis 60  
Statistical analysis description 
This analysis was performed on Day 141. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=78.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
42.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
33.5  
upper limit 
51.9  
Variability estimate 
Standard error of the mean


Dispersion value 
4.7


Statistical analysis title 
Statistical analysis 61  
Statistical analysis description 
This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=105.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
116


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
55


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
48  
upper limit 
62  
Variability estimate 
Standard error of the mean


Dispersion value 
3.5


Statistical analysis title 
Statistical analysis 62  
Statistical analysis description 
This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.1094  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
7.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.6  
upper limit 
15.9  
Variability estimate 
Standard error of the mean


Dispersion value 
4.4


Statistical analysis title 
Statistical analysis 63  
Statistical analysis description 
This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=86.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
91


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
32.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
24.2  
upper limit 
40.5  
Variability estimate 
Standard error of the mean


Dispersion value 
4.1


Statistical analysis title 
Statistical analysis 64  
Statistical analysis description 
This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=100.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
112


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
51


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
43.8  
upper limit 
58.2  
Variability estimate 
Standard error of the mean


Dispersion value 
3.6


Statistical analysis title 
Statistical analysis 65  
Statistical analysis description 
This analysis was performed on Day 155. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDL−c (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=80.


Comparison groups 
MPSK3169A 800 mg Q12W v Placebo


Number of subjects included in analysis 
86


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
21.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
13.1  
upper limit 
30.6  
Variability estimate 
Standard error of the mean


Dispersion value 
4.5



End point title 
Absolute CFB in Total Cholesterol (TC), NonHigh Density Lipoprotein (NonHDLc), and Apolipoprotein B (ApoB) at Day 169 and at Nadir  
End point description 
Nadir is defined as the planned visit, up to day 169, with the greatest mean decrease within a treatment group. mITT population participants with baseline and at least 1 post baseline measurement of TC, nonHDLc and ApoB levels were included in the analysis of this end point. “n” value indicates the number of participants evaluable at a specified timepoint for a particular treatment arm.


End point type 
Secondary


End point timeframe 
Baseline, Day 169, up to Day 169 (Nadir)




Statistical analysis title 
Statistical analysis 1  
Statistical analysis description 
This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
114


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
63.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
51.4  
upper limit 
74.8  
Variability estimate 
Standard error of the mean


Dispersion value 
5.9


Statistical analysis title 
Statistical analysis 2  
Statistical analysis description 
This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.


Comparison groups 
MPSK3169A 200 mg Q8W v Placebo


Number of subjects included in analysis 
85


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.9833  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
0.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
14.7  
upper limit 
14.4  
Variability estimate 
Standard error of the mean


Dispersion value 
7.4


Statistical analysis title 
Statistical analysis 3  
Statistical analysis description 
This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=88.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
90


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0047  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
19.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
6.2  
upper limit 
33.6  
Variability estimate 
Standard error of the mean


Dispersion value 
7


Statistical analysis title 
Statistical analysis 4  
Statistical analysis description 
This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=104.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
109


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
43.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
31.3  
upper limit 
55.2  
Variability estimate 
Standard error of the mean


Dispersion value 
6


Statistical analysis title 
Statistical analysis 5  
Statistical analysis description 
This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
83


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0488  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
15.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.1  
upper limit 
30.3  
Variability estimate 
Standard error of the mean


Dispersion value 
7.7


Statistical analysis title 
Statistical analysis 6  
Statistical analysis description 
This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=114.


Comparison groups 
MPSK3169A 400 mg once every 4 weeks (Q4W) v Placebo


Number of subjects included in analysis 
114


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
81.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
71.3  
upper limit 
91.4  
Variability estimate 
Standard error of the mean


Dispersion value 
5.1


Statistical analysis title 
Statistical analysis 7  
Statistical analysis description 
This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
85


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
59.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
46.3  
upper limit 
72  
Variability estimate 
Standard error of the mean


Dispersion value 
6.5


Statistical analysis title 
Statistical analysis 8  
Statistical analysis description 
This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
90


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
71.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
59.2  
upper limit 
83.7  
Variability estimate 
Standard error of the mean


Dispersion value 
6.2


Statistical analysis title 
Statistical analysis 9  
Statistical analysis description 
This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=109.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
109


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
79.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
69  
upper limit 
89.5  
Variability estimate 
Standard error of the mean


Dispersion value 
5.2


Statistical analysis title 
Statistical analysis 10  
Statistical analysis description 
This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=82.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
83


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
81.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
68.3  
upper limit 
95.4  
Variability estimate 
Standard error of the mean


Dispersion value 
6.9


Statistical analysis title 
Statistical analysis 11  
Statistical analysis description 
This analysis was performed for nonHDLc parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
114


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
67.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
55.6  
upper limit 
79.1  
Variability estimate 
Standard error of the mean


Dispersion value 
6


Statistical analysis title 
Statistical analysis 12  
Statistical analysis description 
This analysis was performed for nonHDLc parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
85


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.8377  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
1.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
13.1  
upper limit 
16.2  
Variability estimate 
Standard error of the mean


Dispersion value 
7.4


Statistical analysis title 
Statistical analysis 13  
Statistical analysis description 
This analysis was performed for nonHDLc parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=88.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
90


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0017  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
22.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
8.4  
upper limit 
36  
Variability estimate 
Standard error of the mean


Dispersion value 
7


Statistical analysis title 
Statistical analysis 14  
Statistical analysis description 
This analysis was performed for nonHDLc parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=104.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
109


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
47


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
35  
upper limit 
59  
Variability estimate 
Standard error of the mean


Dispersion value 
6.1


Statistical analysis title 
Statistical analysis 15  
Statistical analysis description 
This analysis was performed for nonHDLc parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
83


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.334  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
16.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.3  
upper limit 
31.7  
Variability estimate 
Standard error of the mean


Dispersion value 
7.7


Statistical analysis title 
Statistical analysis 16  
Statistical analysis description 
This analysis was performed for nonHDLc parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=114.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
114


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
84.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
74.3  
upper limit 
94.6  
Variability estimate 
Standard error of the mean


Dispersion value 
5.2


Statistical analysis title 
Statistical analysis 17  
Statistical analysis description 
This analysis was performed for nonHDLc parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
85


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
62.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
49.9  
upper limit 
75.8  
Variability estimate 
Standard error of the mean


Dispersion value 
6.6


Statistical analysis title 
Statistical analysis 18  
Statistical analysis description 
This analysis was performed for nonHDLc parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
90


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
75.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
62.9  
upper limit 
87.5  
Variability estimate 
Standard error of the mean


Dispersion value 
6.3


Statistical analysis title 
Statistical analysis 19  
Statistical analysis description 
This analysis was performed for nonHDLc parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=109.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
109


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
81.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
70.9  
upper limit 
91.5  
Variability estimate 
Standard error of the mean


Dispersion value 
5.2


Statistical analysis title 
Statistical analysis 20  
Statistical analysis description 
This analysis was performed for nonHDLc parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=82.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
83


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
83.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
69.7  
upper limit 
97.2  
Variability estimate 
Standard error of the mean


Dispersion value 
6.9


Statistical analysis title 
Statistical analysis 21  
Statistical analysis description 
This analysis was performed for ApoB parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
114


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
42.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
35.4  
upper limit 
49.6  
Variability estimate 
Standard error of the mean


Dispersion value 
3.6


Statistical analysis title 
Statistical analysis 22  
Statistical analysis description 
This analysis was performed for ApoB parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
85


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.786  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
1.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10.1  
upper limit 
7.6  
Variability estimate 
Standard error of the mean


Dispersion value 
4.5


Statistical analysis title 
Statistical analysis 23  
Statistical analysis description 
This analysis was performed for ApoB parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=88.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
90


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.006  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
11.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.4  
upper limit 
20.1  
Variability estimate 
Standard error of the mean


Dispersion value 
4.2


Statistical analysis title 
Statistical analysis 24  
Statistical analysis description 
This analysis was performed for ApoB parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=104.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
109


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
30.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
23.1  
upper limit 
37.6  
Variability estimate 
Standard error of the mean


Dispersion value 
3.7


Statistical analysis title 
Statistical analysis 25  
Statistical analysis description 
This analysis was performed for ApoB parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
83


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0381  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
9.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.5  
upper limit 
18.9  
Variability estimate 
Standard error of the mean


Dispersion value 
4.6


Statistical analysis title 
Statistical analysis 26  
Statistical analysis description 
This analysis was performed for ApoB parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=114.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
114


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
53.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
46.8  
upper limit 
59.7  
Variability estimate 
Standard error of the mean


Dispersion value 
3.3


Statistical analysis title 
Statistical analysis 27  
Statistical analysis description 
This analysis was performed for ApoB parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
85


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
38.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
29.9  
upper limit 
46.5  
Variability estimate 
Standard error of the mean


Dispersion value 
4.2


Statistical analysis title 
Statistical analysis 28  
Statistical analysis description 
This analysis was performed for ApoB parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
90


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
45.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
37.8  
upper limit 
53.7  
Variability estimate 
Standard error of the mean


Dispersion value 
4


Statistical analysis title 
Statistical analysis 29  
Statistical analysis description 
This analysis was performed for ApoB parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=109.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
109


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
52


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
45.4  
upper limit 
58.6  
Variability estimate 
Standard error of the mean


Dispersion value 
3.4


Statistical analysis title 
Statistical analysis 30  
Statistical analysis description 
This analysis was performed for ApoB parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=82.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
83


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
52.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
43.7  
upper limit 
61.2  
Variability estimate 
Standard error of the mean


Dispersion value 
4.4



End point title 
Percentage CFB in TC, NonHDLc, and ApoB at Day 169 and At Nadir  
End point description 
Nadir is defined as the planned visit, up to day 169, with the greatest mean decrease within a treatment group. mITT population participants with baseline and at least 1 post baseline measurement of TC, nonHDLc and ApoB levels were included in the analysis of this end point. “n” value indicates the number of participants evaluable at a specified timepoint for a particular treatment arm.


End point type 
Secondary


End point timeframe 
Baseline, Day 169, up to Day 169 (nadir)




Statistical analysis title 
Statistical analysis 1  
Statistical analysis description 
This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=107.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
114


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
31.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
26  
upper limit 
36.6  
Variability estimate 
Standard error of the mean


Dispersion value 
2.7


Statistical analysis title 
Statistical analysis 2  
Statistical analysis description 
This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=83.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
85


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.9878  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
0.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
6.6  
upper limit 
6.7  
Variability estimate 
Standard error of the mean


Dispersion value 
3.4


Statistical analysis title 
Statistical analysis 3  
Statistical analysis description 
This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=88.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
90


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0077  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
8.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.3  
upper limit 
14.8  
Variability estimate 
Standard error of the mean


Dispersion value 
3.2


Statistical analysis title 
Statistical analysis 4  
Statistical analysis description 
This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=104.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
109


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
21.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
15.8  
upper limit 
26.6  
Variability estimate 
Standard error of the mean


Dispersion value 
2.8


Statistical analysis title 
Statistical analysis 5  
Statistical analysis description 
This analysis was performed for TC parameter on Day 169. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=81.


Comparison groups 
Placebo v MPSK3169A 800 mg Q12W


Number of subjects included in analysis 
83


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0643  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
6.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.4  
upper limit 
13.3  
Variability estimate 
Standard error of the mean


Dispersion value 
3.5


Statistical analysis title 
Statistical analysis 6  
Statistical analysis description 
This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=114.


Comparison groups 
Placebo v MPSK3169A 400 mg once every 4 weeks (Q4W)


Number of subjects included in analysis 
114


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
39.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
35.4  
upper limit 
44.4  
Variability estimate 
Standard error of the mean


Dispersion value 
2.3


Statistical analysis title 
Statistical analysis 7  
Statistical analysis description 
This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=85.


Comparison groups 
Placebo v MPSK3169A 200 mg Q8W


Number of subjects included in analysis 
85


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
30.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
24.8  
upper limit 
36.3  
Variability estimate 
Standard error of the mean


Dispersion value 
2.9


Statistical analysis title 
Statistical analysis 8  
Statistical analysis description 
This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=89.


Comparison groups 
Placebo v MPSK3169A 400 mg Q8W


Number of subjects included in analysis 
90


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
34.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
29.4  
upper limit 
40.4  
Variability estimate 
Standard error of the mean


Dispersion value 
2.8


Statistical analysis title 
Statistical analysis 9  
Statistical analysis description 
This analysis was performed for TC parameter at nadir. LS mean difference, 95% CIs and p−values were based on an analysis of covariance model adjusted for baseline LDLc (<120 mg/dL, ≥120 mg/dL) and diabetes status (yes, no). Number of subjects included in analysis=109.


Comparison groups 
Placebo v MPSK3169A 800 mg Q8W


Number of subjects included in analysis 
109


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
ANCOVA  
Parameter type 
LS mean difference  
Point estimate 
38.4

