Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950... | NCT01592240

ID	Type	Description	Link
2012-001226-10	EudraCT Number

Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950... | NCT01592240 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Q28d Dosing Arm	Experimental	A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q28d dose group will receive subcutaneous administration of PF-04950615 or Placebo once a month.	Drug: PBO Drug: 200mg PF-04950615 (RN316) Drug: 300mg PF-04950615 (RN316)
Q14d Dosing Arm	Experimental	A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q14d dose group will receive subcutaneous administration of PF-04950615 or Placebo every 2 weeks.	Drug: PBO Drug: PF-04950615

Name	Type	Description	Arm Group Labels	Other Names
PBO	Drug	Placebo Q28d	Q28d Dosing Arm
200mg PF-04950615 (RN316)

Outcomes Module

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

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24		Baseline, Week 24
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24		Baseline, Week 12, 24

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Achieve Clinical Research, LLC		Birmingham	Alabama	35216	United States
Medical Affiliated Research Center, Inc.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37994400	Derived	Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
25784512

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
FG001	PF-04950615 50 mg: Every 14 Days

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG0001 subjects FG0010 subjects FG0020 subjects FG0031 subjects FG0041 subjects FG0050 subjects FG0060 subjects
Death		FG0000 subjects FG0011 subjects FG0020 subjects FG0030 subjects FG004
Lost to Follow-up		FG0001 subjects FG0013 subjects FG0021 subjects FG0030 subjects FG004
Protocol Violation		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
Withdrawal by Subject		FG0000 subjects FG0014 subjects FG0024 subjects FG0031 subjects FG004
Other		FG0000 subjects FG0013 subjects FG0021 subjects FG0031 subjects FG004
Did Not Meet Entrance Criteria		FG0001 subjects FG0010 subjects FG0021 subjects FG0030 subjects FG004

Arm/Group Information

ID	Title	Description
BG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
BG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
BG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
BG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
BG004	Placebo: Every 28 Days	Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
BG005	PF-04950615 200 mg: Every 28 Days	Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
BG006	PF-04950615 300 mg: Every 28 Days	Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.
BG007	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00060.5± 9.84 BG00159.1± 11.26 BG00261.9± 9.58 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00025 BG00126 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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

Posted

Mean

95% Confidence Interval

milligram per deciliter (mg/dL)

Baseline, Week 12

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
OG004	Placebo: Every 28 Days	Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.
OG005	PF-04950615 200 mg: Every 28 Days	Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.
OG006	PF-04950615 300 mg: Every 28 Days	Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.

Units	Counts
Participants	OG00047 OG00144 OG00242 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-2.6(-10.14 to 4.98) OG001-36.9(-44.55 to -29.17) OG002-47.6(-55.45 to -39.85) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed models repeated measures analysis		<0.001		Adjusted mean difference	-34.28			2-Sided	95	-45.06	-23.50					Superiority or Other
OG000 OG002		Mixed models repeated measures analysis		<0.001

Secondary

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

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

Posted

Mean

95% Confidence Interval

milligram per deciliter

Baseline, Week 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

Posted

Mean

95% Confidence Interval

percent change

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

Posted

Mean

95% Confidence Interval

milligram per deciliter

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

Posted

Mean

95% Confidence Interval

percent change

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

Posted

Mean

95% Confidence Interval

milligram per deciliter

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

Posted

Mean

95% Confidence Interval

percent change

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

Posted

Mean

95% Confidence Interval

milligram per deciliter

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

Posted

Mean

95% Confidence Interval

percent change

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

Posted

Mean

95% Confidence Interval

milligram per deciliter

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

Posted

Mean

95% Confidence Interval

percent change

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

Change From Baseline in Total Cholesterol at Week 12 and 24

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

Posted

Mean

Standard Deviation

milligram per deciliter

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

Posted

Mean

Standard Deviation

milligram per deciliter

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

Posted

Mean

Standard Deviation

milligram per deciliter

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

Change From Baseline in Triglycerides at Week 12 and 24

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

Posted

Mean

Standard Deviation

milligram per deciliter

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

Percent Change From Baseline in Triglycerides at Week 12 and 24

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

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

Posted

Mean

Standard Deviation

milligram per deciliter

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

Posted

Mean

Standard Deviation

percent change

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Secondary

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

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

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

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG001	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG002	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
OG003	PF-04950615 200 mg: Every 28 Days

Secondary

Percentage of Participants With Injection Site Adverse Events

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

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

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days

Secondary

Plasma Concentration of PF-04950615 at Week 12 and 24

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

Posted

Mean

Standard Deviation

Microgram per milliliter

Week 12, 24

ID	Title	Description
OG000	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG001	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG002	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.
OG003	PF-04950615 200 mg: Every 28 Days	Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.

Secondary

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

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

Posted

Number

percentage of participants

Week 12, 24

ID	Title	Description
OG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.
OG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.
OG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.
OG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo: Every 14 Days	Participants received single dose of subcutaneous (SC) injection of placebo matched to PF-04950615 once every 14 days for 24 weeks.	7	49	35	49
EG001	PF-04950615 50 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 50 milligram (mg) once every 14 days for 24 weeks.	4	50	27	50
EG002	PF-04950615 100 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 100 mg once every 14 days for 24 weeks.	2	51	38	51
EG003	PF-04950615 150 mg: Every 14 Days	Participants received single dose of SC injection of PF-04950615 150 mg once every 14 days for 24 weeks.	4	49	35	49
EG004	Placebo: Every 28 Days	Participants received single dose of SC injection of placebo matched to PF-04950615 once every 28 days for 24 weeks.	2	51	28	51
EG005	PF-04950615 200 mg: Every 28 Days	Participants received single dose of SC injection of PF-04950615 200 mg once every 28 days for 24 weeks.	5	50	32	50
EG006	PF-04950615 300 mg: Every 28 Days	Participants received single dose of SC injection of PF-04950615 300 mg once every 28 days for 24 weeks.	4	51	25	51

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG0030 affected49 at risk EG0040 affected51 at risk EG0050 affected50 at risk EG0061 affected51 at risk
Angina unstable	Cardiac disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 16.0	Non-systematic Assessment		EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Chest pain	General disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Bronchitis viral	Infections and infestations	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Cellulitis	Infections and infestations	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected51 at risk EG003
Localised infection	Infections and infestations	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Pneumonia	Infections and infestations	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected51 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 16.0	Non-systematic Assessment		EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Wound infection	Infections and infestations	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected51 at risk EG003
Chest injury	Injury, poisoning and procedural complications	MedDRA 16.0	Non-systematic Assessment		EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Exposure via father	Injury, poisoning and procedural complications	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 16.0	Non-systematic Assessment		EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected51 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Non-systematic Assessment		EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected51 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected51 at risk EG003
Endometrial cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Non-systematic Assessment	This event was gender specific.	EG0001 affected25 at risk EG0010 affected26 at risk EG0020 affected26 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Non-systematic Assessment		EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected51 at risk EG003
Presyncope	Nervous system disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Alcoholism	Psychiatric disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Bipolar disorder	Psychiatric disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Drug dependence	Psychiatric disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Prostatic dysplasia	Reproductive system and breast disorders	MedDRA 16.0	Non-systematic Assessment	This event was gender specific.	EG0001 affected25 at risk EG0010 affected24 at risk EG0020 affected26 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected51 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected51 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment		EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0011 affected50 at risk EG0020 affected51 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 16.0	Non-systematic Assessment		EG0000 affected49 at risk EG0010 affected50 at risk EG0021 affected51 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 16.0	Non-systematic Assessment		EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 16.0	Non-systematic Assessment		EG0001 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0025 affected51 at risk EG0032 affected49 at risk EG0040 affected51 at risk EG0052 affected50 at risk EG0060 affected51 at risk
Constipation	Gastrointestinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0003 affected49 at risk EG0011 affected50 at risk EG0020 affected51 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0004 affected49 at risk EG0013 affected50 at risk EG0024 affected51 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0025 affected51 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0022 affected51 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0002 affected49 at risk EG0010 affected50 at risk EG0021 affected51 at risk EG003
Fatigue	General disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0021 affected51 at risk EG003
Injection site erythema	General disorders	MedDRA 16.0	Non-systematic Assessment	EG0002 affected49 at risk EG0012 affected50 at risk EG0024 affected51 at risk EG003
Injection site pain	General disorders	MedDRA 16.0	Non-systematic Assessment	EG0004 affected49 at risk EG0014 affected50 at risk EG0021 affected51 at risk EG003
Injection site pruritus	General disorders	MedDRA 16.0	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Injection site reaction	General disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected49 at risk EG0013 affected50 at risk EG0021 affected51 at risk EG003
Bronchitis	Infections and infestations	MedDRA 16.0	Non-systematic Assessment	EG0004 affected49 at risk EG0012 affected50 at risk EG0023 affected51 at risk EG003
Influenza	Infections and infestations	MedDRA 16.0	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0022 affected51 at risk EG003
Localised infection	Infections and infestations	MedDRA 16.0	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0023 affected51 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 16.0	Non-systematic Assessment	EG0006 affected49 at risk EG0018 affected50 at risk EG0027 affected51 at risk EG003
Sinusitis	Infections and infestations	MedDRA 16.0	Non-systematic Assessment	EG0002 affected49 at risk EG0013 affected50 at risk EG0023 affected51 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 16.0	Non-systematic Assessment	EG0007 affected49 at risk EG0014 affected50 at risk EG0025 affected51 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 16.0	Non-systematic Assessment	EG0003 affected49 at risk EG0011 affected50 at risk EG0025 affected51 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 16.0	Non-systematic Assessment	EG0000 affected49 at risk EG0011 affected50 at risk EG0024 affected51 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 16.0	Non-systematic Assessment	EG0000 affected49 at risk EG0012 affected50 at risk EG0023 affected51 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 16.0	Non-systematic Assessment	EG0000 affected49 at risk EG0010 affected50 at risk EG0020 affected51 at risk EG003
Arthalgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Non-systematic Assessment	EG0002 affected49 at risk EG0010 affected50 at risk EG0026 affected51 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Non-systematic Assessment	EG0002 affected49 at risk EG0011 affected50 at risk EG0024 affected51 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Non-systematic Assessment	EG0002 affected49 at risk EG0013 affected50 at risk EG0022 affected51 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0021 affected51 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected49 at risk EG0013 affected50 at risk EG0021 affected51 at risk EG003
Dizziness	Nervous system disorders	MedDRA 16.0	Non-systematic Assessment	EG0001 affected49 at risk EG0010 affected50 at risk EG0024 affected51 at risk EG003
Headache	Nervous system disorders	MedDRA 16.0	Non-systematic Assessment	EG0002 affected49 at risk EG0012 affected50 at risk EG0022 affected51 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Non-systematic Assessment	EG0005 affected49 at risk EG0012 affected50 at risk EG0021 affected51 at risk EG003
Hypertension	Vascular disorders	MedDRA 16.0	Non-systematic Assessment	EG0004 affected49 at risk EG0010 affected50 at risk EG0022 affected51 at risk EG003

Title

Denominators

Categories

Title	Measurements
	OG000-3.6(-11.16 to 3.88) OG001-32.0(-39.72 to -24.37) OG002-46.8(-54.44 to -39.25) OG003-44.7(-52.19 to -37.16) OG004-0.6(-7.69 to 6.54) OG005-24.3(-31.21 to -17.49) OG006-30.9(-37.71 to -24.18)

Group IDs	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-28.41	2-Sided	95	-39.15	-17.67	Superiority or Other
OG000 OG002	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-43.21	2-Sided	95	-53.90	-32.51	Superiority or Other
OG000 OG003	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-41.03	2-Sided	95	-51.66	-30.41	Superiority or Other
OG004 OG005	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-23.77	2-Sided	95	-33.70	-13.84	Superiority or Other
OG004 OG006	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-30.36	2-Sided	95	-40.24	-20.49	Superiority or Other

Title

Denominators

Categories

Percent Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00144
- ParticipantsOG00242
- ParticipantsOG00346
- ParticipantsOG00446
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG0000.6(-6.34 to 7.54) OG001-34.4(-41.47 to -27.34) OG002-41.7(-48.90 to -34.54) OG003

Percent Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-35.00	2-Sided	95	-44.91	-25.10	Superiority or Other
OG000 OG002	Week 12	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-42.32	2-Sided	95	-52.30	-32.33	Superiority or Other
OG000 OG003	Week 12	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-53.12	2-Sided	95	-62.97	-43.27	Superiority or Other
OG004 OG005	Week 12	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-26.96	2-Sided	95	-38.25	-15.67	Superiority or Other
OG004 OG006	Week 12	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-41.13	2-Sided	95	-52.32	-29.94	Superiority or Other
OG000 OG001	Week 24	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-29.09	2-Sided	95	-38.42	-19.77	Superiority or Other
OG000 OG002	Week 24	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-40.14	2-Sided	95	-49.43	-30.86	Superiority or Other
OG000 OG003	Week 24	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-39.16	2-Sided	95	-48.37	-29.94	Superiority or Other
OG004 OG005	Week 24	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-23.79	2-Sided	95	-32.88	-14.70	Superiority or Other
OG004 OG006	Week 24	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-29.08	2-Sided	95	-38.13	-20.04	Superiority or Other

Title

Denominators

Categories

Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00346
- ParticipantsOG00447
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG0000.3(-1.80 to 2.39) OG0011.9(-0.20 to 4.06) OG0022.0(-0.08 to 4.13) OG003

Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12	Mixed models repeated measures analysis	0.281	Adjusted Mean Difference	1.64	2-Sided	95	-1.35	4.63	Superiority or Other
OG000 OG002	Week 12	Mixed models repeated measures analysis	0.251	Adjusted mean difference	1.73	2-Sided	95	-1.24	4.71	Superiority or Other
OG000 OG003	Week 12	Mixed models repeated measures analysis	0.724	Adjusted mean difference	0.53	2-Sided	95	-2.43	3.50	Superiority or Other
OG004 OG005	Week 12	Mixed models repeated measures analysis	0.007	Adjusted mean difference	4.45	2-Sided	95	1.21	7.70	Superiority or Other
OG004 OG006	Week 12	Mixed models repeated measures analysis	0.019	Adjusted mean difference	3.86	2-Sided	95	0.63	7.09	Superiority or Other
OG000 OG001	Week 24	Mixed models repeated measures analysis	0.225	Adjusted mean difference	1.72	2-Sided	95	-1.07	4.51	Superiority or Other
OG000 OG002	Week 24	Mixed models repeated measures analysis	0.571	Adjusted mean difference	0.79	2-Sided	95	-1.97	3.56	Superiority or Other
OG000 OG003	Week 24	Mixed models repeated measures analysis	0.725	Adjusted mean difference	0.49	2-Sided	95	-2.25	3.24	Superiority or Other
OG004 OG005	Week 24	Mixed models repeated measures analysis	0.268	Adjusted mean difference	2.01	2-Sided	95	-1.56	5.57	Superiority or Other
OG004 OG006	Week 24	Mixed models repeated measures analysis	0.996	Adjusted mean difference	-0.01	2-Sided	95	-3.55	3.54	Superiority or Other

Title

Denominators

Categories

Percent Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00346
- ParticipantsOG00447
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG0001.2(-2.87 to 5.25) OG0014.6(0.48 to 8.74) OG0023.8(-0.27 to 7.89) OG003

Percent Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12	Mixed models repeated measures analysis	0.246	Adjusted mean difference	3.41	2-Sided	95	-2.38	9.21	Superiority or Other
OG000 OG002	Week 12	Mixed models repeated measures analysis	0.371	Adjusted mean difference	2.62	2-Sided	95	-3.14	8.38	Superiority or Other
OG000 OG003	Week 12	Mixed models repeated measures analysis	0.643	Adjusted mean difference	1.35	2-Sided	95	-4.40	7.10	Superiority or Other
OG004 OG005	Week 12	Mixed models repeated measures analysis	0.018	Adjusted mean difference	7.66	2-Sided	95	1.33	13.99	Superiority or Other
OG004 OG006	Week 12	Mixed models repeated measures analysis	0.043	Adjusted mean difference	6.52	2-Sided	95	0.22	12.83	Superiority or Other
OG000 OG001	Week 24	Mixed models repeated measures analysis	0.160	Adjusted mean difference	3.90	2-Sided	95	-1.56	9.36	Superiority or Other
OG000 OG002	Week 24	Mixed models repeated measures analysis	0.758	Adjusted mean difference	0.85	2-Sided	95	-4.56	6.25	Superiority or Other
OG000 OG003	Week 24	Mixed models repeated measures analysis	0.347	Adjusted mean difference	2.57	2-Sided	95	-2.81	7.95	Superiority or Other
OG004 OG005	Week 24	Mixed models repeated measures analysis	0.343	Adjusted mean difference	2.99	2-Sided	95	-3.22	9.21	Superiority or Other
OG004 OG006	Week 24	Mixed models repeated measures analysis	0.824	Adjusted mean difference	-0.70	2-Sided	95	-6.87	5.48	Superiority or Other

Title

Denominators

Categories

Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00145
- ParticipantsOG00244
- ParticipantsOG00346
- ParticipantsOG00447
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG000-2.8(-7.65 to 2.02) OG001-21.4(-26.26 to -16.48) OG002-30.5(-35.40 to -25.57) OG003

Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12	Mixed models repeated measures analysis	<0.001	Adjusted Mean Difference	-18.55	2-Sided	95	-25.44	-11.67	Superiority or Other
OG000 OG002	Week 12	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-27.67	2-Sided	95	-34.55	-20.79	Superiority or Other
OG000 OG003	Week 12	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-32.09	2-Sided	95	-38.95	-25.22	Superiority or Other
OG004 OG005	Week 12	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-14.56	2-Sided	95	-22.89	-6.24	Superiority or Other
OG004 OG006	Week 12	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-28.50	2-Sided	95	-36.83	-20.16	Superiority or Other
OG000 OG001	Week 24	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-19.67	2-Sided	95	-27.07	-12.27	Superiority or Other
OG000 OG002	Week 24	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-28.17	2-Sided	95	-35.52	-20.82	Superiority or Other
OG000 OG003	Week 24	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-25.41	2-Sided	95	-32.73	-18.09	Superiority or Other
OG004 OG005	Week 24	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-12.72	2-Sided	95	-19.35	-6.09	Superiority or Other
OG004 OG006	Week 24	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-16.85	2-Sided	95	-23.47	-10.23	Superiority or Other

Title

Denominators

Categories

Percent Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00145
- ParticipantsOG00244
- ParticipantsOG00346
- ParticipantsOG00447
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG000-1.9(-7.31 to 3.45) OG001-23.5(-28.94 to -18.07) OG002-32.5(-37.93 to -27.01) OG003

Percent Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-21.58	2-Sided	95	-29.23	-13.92	Superiority or Other
OG000 OG002	Week 12	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-30.54	2-Sided	95	-38.19	-22.89	Superiority or Other
OG000 OG003	Week 12	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-35.95	2-Sided	95	-43.59	-28.31	Superiority or Other
OG004 OG005	Week 12	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-17.14	2-Sided	95	-25.87	-8.41	Superiority or Other
OG004 OG006	Week 12	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-30.72	2-Sided	95	-39.45	-21.98	Superiority or Other
OG000 OG001	Week 24	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-22.09	2-Sided	95	-30.32	-13.86	Superiority or Other
OG000 OG002	Week 24	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-30.95	2-Sided	95	-39.13	-22.77	Superiority or Other
OG000 OG003	Week 24	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-27.23	2-Sided	95	-35.38	-19.09	Superiority or Other
OG004 OG005	Week 24	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-15.34	2-Sided	95	-22.90	-7.78	Superiority or Other
OG004 OG006	Week 24	Mixed models repeated measures analysis	<0.001	Adjusted mean difference	-19.15	2-Sided	95	-26.70	-11.59	Superiority or Other

Title

Denominators

Categories

Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00145
- ParticipantsOG00244
- ParticipantsOG00346
- ParticipantsOG00447
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG0002.1(-3.56 to 7.85) OG0013.9(-1.83 to 9.67) OG0027.6(1.84 to 13.33) OG003

Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12	Mixed models repeated measures analysis	0.667	Adjusted Mean Difference	1.77	2-Sided	95	-6.33	9.88	Superiority or Other
OG000 OG002	Week 12	Mixed models repeated measures analysis	0.187	Adjusted mean difference	5.44	2-Sided	95	-2.66	13.54	Superiority or Other
OG000 OG003	Week 12	Mixed models repeated measures analysis	0.352	Adjusted mean difference	3.82	2-Sided	95	-4.25	11.90	Superiority or Other
OG004 OG005	Week 12	Mixed models repeated measures analysis	0.090	Adjusted mean difference	5.60	2-Sided	95	-0.89	12.09	Superiority or Other
OG004 OG006	Week 12	Mixed models repeated measures analysis	0.184	Adjusted mean difference	4.36	2-Sided	95	-2.10	10.82	Superiority or Other
OG000 OG001	Week 24	Mixed models repeated measures analysis	0.879	Adjusted mean difference	0.59	2-Sided	95	-7.09	8.28	Superiority or Other
OG000 OG002	Week 24	Mixed models repeated measures analysis	0.911	Adjusted mean difference	0.43	2-Sided	95	-7.17	8.02	Superiority or Other
OG000 OG003	Week 24	Mixed models repeated measures analysis	0.283	Adjusted mean difference	4.12	2-Sided	95	-3.44	11.69	Superiority or Other
OG004 OG005	Week 24	Mixed models repeated measures analysis	0.728	Adjusted mean difference	-1.41	2-Sided	95	-9.41	6.59	Superiority or Other
OG004 OG006	Week 24	Mixed models repeated measures analysis	0.587	Adjusted mean difference	-2.19	2-Sided	95	-10.13	5.75	Superiority or Other

Title

Denominators

Categories

Percent Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00145
- ParticipantsOG00244
- ParticipantsOG00346
- ParticipantsOG00447
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG0002.6(-4.06 to 9.28) OG0012.0(-4.65 to 8.55) OG0024.9(-1.63 to 11.48) OG003

Percent Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12	Mixed models repeated measures analysis	0.890	Adjusted mean difference	-0.66	2-Sided	95	-10.05	8.74	Superiority or Other
OG000 OG002	Week 12	Mixed models repeated measures analysis	0.625	Adjusted mean difference	2.32	2-Sided	95	-7.04	11.68	Superiority or Other
OG000 OG003	Week 12	Mixed models repeated measures analysis	0.172	Adjusted mean difference	6.54	2-Sided	95	-2.86	15.94	Superiority or Other
OG004 OG005	Week 12	Mixed models repeated measures analysis	0.109	Adjusted mean difference	3.50	2-Sided	95	-0.79	7.80	Superiority or Other
OG004 OG006	Week 12	Mixed models repeated measures analysis	0.218	Adjusted mean difference	2.67	2-Sided	95	-1.60	6.94	Superiority or Other
OG000 OG001	Week 24	Mixed models repeated measures analysis	0.812	Adjusted mean difference	-0.86	2-Sided	95	-8.01	6.29	Superiority or Other
OG000 OG002	Week 24	Mixed models repeated measures analysis	0.749	Adjusted mean difference	-1.15	2-Sided	95	-8.24	5.94	Superiority or Other
OG000 OG003	Week 24	Mixed models repeated measures analysis	0.108	Adjusted mean difference	5.82	2-Sided	95	-1.29	12.93	Superiority or Other
OG004 OG005	Week 24	Mixed models repeated measures analysis	0.752	Adjusted mean difference	-0.83	2-Sided	95	-5.99	4.34	Superiority or Other
OG004 OG006	Week 24	Mixed models repeated measures analysis	0.550	Adjusted mean difference	-1.55	2-Sided	95	-6.68	3.57	Superiority or Other

Title

Denominators

Categories

Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00145
- ParticipantsOG00244
- ParticipantsOG00346
- ParticipantsOG00447
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG0001.0(-0.99 to 2.95) OG0011.2(-0.84 to 3.18) OG0022.3(0.29 to 4.32) OG003

Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00346

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12	Mixed models repeated measures analysis	0.893	Adjusted Mean Difference	0.19	2-Sided	95	-2.62	3.00	Superiority or Other
OG000 OG002	Week 12	Mixed models repeated measures analysis	0.355	Adjusted mean difference	1.33	2-Sided	95	-1.49	4.15	Superiority or Other
OG000 OG003	Week 12	Mixed models repeated measures analysis	0.655	Adjusted mean difference	-0.64	2-Sided	95	-3.45	2.17	Superiority or Other
OG004 OG005	Week 12	Mixed models repeated measures analysis	0.719	Adjusted mean difference	-0.49	2-Sided	95	-3.20	2.21	Superiority or Other
OG004 OG006	Week 12	Mixed models repeated measures analysis	0.768	Adjusted mean difference	0.41	2-Sided	95	-2.31	3.12	Superiority or Other
OG000 OG001	Week 24	Mixed models repeated measures analysis	0.199	Adjusted mean difference	1.66	2-Sided	95	-0.88	4.20	Superiority or Other
OG000 OG002	Week 24	Mixed models repeated measures analysis	0.483	Adjusted mean difference	0.90	2-Sided	95	-1.62	3.41	Superiority or Other
OG000 OG003	Week 24	Mixed models repeated measures analysis	0.420	Adjusted mean difference	1.03	2-Sided	95	-1.49	3.56	Superiority or Other
OG004 OG005	Week 24	Mixed models repeated measures analysis	0.488	Adjusted mean difference	-0.69	2-Sided	95	-2.67	1.28	Superiority or Other
OG004 OG006	Week 24	Mixed models repeated measures analysis	0.694	Adjusted mean difference	-0.39	2-Sided	95	-2.36	1.58	Superiority or Other

Title

Denominators

Categories

Percent Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00145
- ParticipantsOG00244
- ParticipantsOG00346
- ParticipantsOG00447
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG0008.1(-14.72 to 30.96) OG00118.4(-4.09 to 40.90) OG0028.5(-13.70 to 30.72) OG003

Percent Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00346

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12	Mixed models repeated measures analysis	0.527	Adjusted mean difference	10.29	2-Sided	95	-21.73	42.30	Superiority or Other
OG000 OG002	Week 12	Mixed models repeated measures analysis	0.981	Adjusted mean difference	0.39	2-Sided	95	-31.49	32.26	Superiority or Other
OG000 OG003	Week 12	Mixed models repeated measures analysis	0.974	Adjusted mean difference	0.54	2-Sided	95	-31.72	32.80	Superiority or Other
OG004 OG005	Week 12	Mixed models repeated measures analysis	0.640	Adjusted mean difference	-1.58	2-Sided	95	-8.25	5.09	Superiority or Other
OG004 OG006	Week 12	Mixed models repeated measures analysis	0.750	Adjusted mean difference	1.08	2-Sided	95	-5.61	7.77	Superiority or Other
OG000 OG001	Week 24	Mixed models repeated measures analysis	0.509	Adjusted mean difference	9.80	2-Sided	95	-19.41	39.01	Superiority or Other
OG000 OG002	Week 24	Mixed models repeated measures analysis	0.855	Adjusted mean difference	-2.69	2-Sided	95	-31.76	26.38	Superiority or Other
OG000 OG003	Week 24	Mixed models repeated measures analysis	0.839	Adjusted mean difference	3.04	2-Sided	95	-26.39	32.47	Superiority or Other
OG004 OG005	Week 24	Mixed models repeated measures analysis	0.392	Adjusted mean difference	-1.99	2-Sided	95	-6.57	2.59	Superiority or Other
OG004 OG006	Week 24	Mixed models repeated measures analysis	0.565	Adjusted mean difference	-1.33	2-Sided	95	-5.91	3.24	Superiority or Other

Title

Denominators

Categories

Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00346
- ParticipantsOG00447
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG000-5.6± 29.58 OG001-35.8± 24.73 OG002-52.7± 32.67 OG003

Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Title

Denominators

Categories

Percent Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00346
- ParticipantsOG00447
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG000-2.35± 14.406 OG001-18.96± 12.299 OG002-26.45± 14.943 OG003

Percent Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Title

Denominators

Categories

Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00145
- ParticipantsOG00244
- ParticipantsOG00346
- ParticipantsOG00447
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG0001.654± 9.8020 OG001-0.515± 17.6889 OG002-2.956± 9.9368 OG003

Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Title

Denominators

Categories

Percent Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00145
- ParticipantsOG00244
- ParticipantsOG00346
- ParticipantsOG00447
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG0006.11± 30.573 OG00140.43± 333.949 OG002-11.89± 22.517 OG003

Percent Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Title

Denominators

Categories

Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00142
- ParticipantsOG00241
- ParticipantsOG00342
- ParticipantsOG00445
- ParticipantsOG00548
- ParticipantsOG00649

Title	Measurements
	OG000-12.3± 50.98 OG001-11.8± 35.82 OG002-6.0± 46.43 OG003

Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00141
- ParticipantsOG00242
- ParticipantsOG00343

Title

Denominators

Categories

Percent Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00142
- ParticipantsOG00241
- ParticipantsOG00342
- ParticipantsOG00445
- ParticipantsOG00548
- ParticipantsOG00649

Title	Measurements
	OG0009.62± 71.415 OG0012.81± 54.888 OG002-3.77± 54.845 OG003

Percent Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00141
- ParticipantsOG00242
- ParticipantsOG00343

Title

Denominators

Categories

Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00346
- ParticipantsOG00447
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG000-14.1± 54.92 OG001-28.7± 76.49 OG002-17.5± 87.65 OG003

Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Title

Denominators

Categories

Percent Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00244
- ParticipantsOG00346
- ParticipantsOG00447
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG000-1.17± 42.789 OG001-5.01± 40.253 OG002-7.13± 35.229 OG003

Percent Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Title

Denominators

Categories

Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00346
- ParticipantsOG00447
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG000-5.7± 26.92 OG001-37.5± 22.40 OG002-55.0± 32.75 OG003

Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Title

Denominators

Categories

Percent Change at Week 12

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00243
- ParticipantsOG00346
- ParticipantsOG00447
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG000-2.28± 20.234 OG001-28.34± 15.836 OG002-38.52± 21.362 OG003

Percent Change at Week 24

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Title

Denominators

Categories

Week 12

- ParticipantsOG00043
- ParticipantsOG00141
- ParticipantsOG00242
- ParticipantsOG00348
- ParticipantsOG00449

Title	Measurements
	OG0001.0157± 2.09363 OG0011.4737± 1.35406 OG0022.0516± 2.25916 OG003

Week 24

- ParticipantsOG00040
- ParticipantsOG00142
- ParticipantsOG00246
- ParticipantsOG00347

Title

Denominators

Categories

Week 12: <100 mg/dL

- ParticipantsOG00047
- ParticipantsOG00144
- ParticipantsOG00242
- ParticipantsOG00346
- ParticipantsOG00446
- ParticipantsOG00548
- ParticipantsOG00650

Title	Measurements
	OG00048.9 OG00190.9 OG00295.2 OG003

Week 24: <100 mg/dL

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Week 12: <70 mg/dL

- ParticipantsOG00047
- ParticipantsOG00144
- ParticipantsOG00242
- ParticipantsOG00346

Week 24: <70 mg/dL

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Week 12: <40 mg/dL

- ParticipantsOG00047
- ParticipantsOG00144
- ParticipantsOG00242
- ParticipantsOG00346

Week 24: <40 mg/dL

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Week 12: <25 mg/dL

- ParticipantsOG00047
- ParticipantsOG00144
- ParticipantsOG00242
- ParticipantsOG00346

Week 24: <25 mg/dL

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00245
- ParticipantsOG00347

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Week 12, Less than 100 mg/dL	Regression, Logistic	<0.001	Odds Ratio (OR)	14.964	2-Sided	95	3.997	56.020	Superiority or Other
OG000 OG002	Week 12, Less than 100 mg/dL	Regression, Logistic	<0.001	Odds Ratio (OR)	49.615	2-Sided	95	7.984	308.328	Superiority or Other
OG000 OG003	Week 12, Less than 100 mg/dL	Regression, Logistic	<0.001	Odds Ratio (OR)	12.842	2-Sided	95	3.674	44.892	Superiority or Other
OG004 OG005	Week 12, Less than 100 mg/dL	Regression, Logistic	0.010	Odds Ratio (OR)	3.107	2-Sided	95	1.304	7.401	Superiority or Other
OG004 OG006	Week 12, Less than 100 mg/dL	Regression, Logistic	<0.001	Odds Ratio (OR)	6.048	2-Sided	95	2.402	15.225	Superiority or Other
OG000 OG001	Week 24, Less than 100 mg/dL	Regression, Logistic	<0.001	Odds Ratio (OR)	12.773	2-Sided	95	3.932	41.495	Superiority or Other
OG000 OG002	Week 24, Less than 100 mg/dL	Regression, Logistic	<0.001	Odds Ratio (OR)	36.886	2-Sided	95	8.330	163.335	Superiority or Other
OG000 OG003	Week 24, Less than 100 mg/dL	Regression, Logistic	<0.001	Odds Ratio (OR)	20.750	2-Sided	95	5.741	75.006	Superiority or Other
OG004 OG005	Week 24, Less than 100 mg/dL	Regression, Logistic	0.001	Odds Ratio (OR)	6.219	2-Sided	95	2.061	18.764	Superiority or Other
OG004 OG006	Week 24, Less than 100 mg/dL	Regression, Logistic	0.001	Odds Ratio (OR)	6.205	2-Sided	95	2.060	18.693	Superiority or Other
OG000 OG001	Week 12, Less than 70 mg/dL	Regression, Logistic	<0.001	Odds Ratio (OR)	27.703	2-Sided	95	5.752	133.423	Superiority or Other
OG000 OG002	Week 12, Less than 70 mg/dL	Regression, Logistic	<0.001	Odds Ratio (OR)	71.177	2-Sided	95	13.783	367.564	Superiority or Other
OG000 OG003	Week 12, Less than 70 mg/dL	Regression, Logistic	<0.001	Odds Ratio (OR)	100.667	2-Sided	95	19.855	510.387	Superiority or Other
OG004 OG005	Week 12, Less than 70 mg/dL.	Regression, Logistic	<0.001							Superiority or Other
OG000 OG001	Week 24, Less than 70 mg/dL.	Regression, Logistic	<0.001	Odds Ratio (OR)	24.941	2-Sided	95	6.336	98.169	Superiority or Other
OG000 OG002	Week 24, Less than 70 mg/dL.	Regression, Logistic	<0.001	Odds Ratio (OR)	80.004	2-Sided	95	18.094	353.742	Superiority or Other
OG000 OG003	Week 24, Less than 70 mg/dL.	Regression, Logistic	<0.001	Odds Ratio (OR)	42.101	2-Sided	95	10.621	166.894	Superiority or Other
OG004 OG005	Week 24, Less than 70 mg/dL.	Regression, Logistic	0.023	Odds Ratio (OR)	11.700	2-Sided	95	1.396	98.075	Superiority or Other
OG004 OG006	Week 24, Less than 70 mg/dL	Regression, Logistic	<0.001	Odds Ratio (OR)	36.841	2-Sided	95	4.527	299.817	Superiority or Other
OG000 OG001	Week 12, Less than 40 mg/dL.	Regression, Logistic	<0.001							Superiority or Other
OG000 OG002	Week 12, Less than 40 mg/dL.	Regression, Logistic	<0.001							Superiority or Other
OG004 OG005	Week 12, Less than 40 mg/dL.	Regression, Logistic	<0.001							Superiority or Other
OG000 OG001	Week 24, Less than 40 mg/dL.	Regression, Logistic	<0.001							Superiority or Other
OG000 OG002	Week 24, Less than 40 mg/dL.	Regression, Logistic	<0.001							Superiority or Other
OG004 OG005	Week 24, Less than 40 mg/dL.	Regression, Logistic	<0.001							Superiority or Other
OG000 OG001	Week 12, Less than 25 mg/dL.	Regression, Logistic	<0.001							Superiority or Other
OG000 OG002	Week 12, Less than 25 mg/dL.	Regression, Logistic	<0.001							Superiority or Other
OG004 OG005	Week 12, Less than 25 mg/dL.	Regression, Logistic	<0.001							Superiority or Other
OG000 OG001	Week 24, Less than 25 mg/dL	Regression, Logistic	1.000	Odds Ratio (OR)	1.587					Superiority or Other
OG000 OG002	Week 24, Less than 25 mg/dL.	Regression, Logistic	<0.001							Superiority or Other
OG004 OG005	Week 24, Less than 25 mg/dL	Regression, Logistic	1.000	Odds Ratio (OR)	0.925					Superiority or Other

Title	Measurements
	OG000-0.9(-7.39 to 5.64) OG001-30.0(-36.64 to -23.29) OG002-41.0(-47.62 to -34.42) OG003-40.0(-46.55 to -33.51) OG0042.4(-4.08 to 8.96) OG005-21.3(-27.63 to -15.07) OG006-26.6(-32.84 to -20.45)

Title	Measurements
	OG000-2.5(-7.68 to 2.66) OG001-22.2(-27.46 to -16.89) OG002-30.7(-35.92 to -25.44) OG003-27.9(-33.09 to -22.75) OG004-2.9(-7.70 to 1.83) OG005-15.7(-20.26 to -11.06) OG006-19.8(-24.32 to -15.26)

Title	Measurements
	OG000-1.5(-7.27 to 4.25) OG001-23.6(-29.48 to -17.72) OG002-32.5(-38.29 to -26.64) OG003-28.7(-34.50 to -22.99) OG004-1.4(-6.88 to 3.98) OG005-16.8(-22.04 to -11.54) OG006-20.6(-25.76 to -15.42)

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases