Long Term Safety Study of PRALUENT

• Sponsor: Regeneron Pharmaceuticals (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03694197
• Collaborator: Sanofi (Industry)
• Enrollment: 1,389
• Locations: 124
• Arm: 1
• Actual Duration (Months): 18.3
• Patients Per Site: 11.2
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed the neurocognitive function study R727-CL-1532 (NCT02957682).

The secondary objectives of the study were:

• To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C)

• To evaluate the effect of PRALUENT on other lipid parameters

• To evaluate the effect of PRALUENT on gonadal steroid hormones

Condition or Disease	Intervention/Treatment	Phase
Heterozygous Familial Hypercholesterolemia; Non-familial Hypercholesterolemia	Drug: Praluent	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 1389 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Long Term Safety Study of PRALUENT in Patients With Heterozygous Familial Hypercholesterolemia or With Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk and Previously Enrolled in the Neurocognitive Function Trial
• Actual Study Start Date: Sep 28, 2018
• Actual Primary Completion Date: Apr 8, 2020
• Actual Study Completion Date: Apr 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Open label	Drug: Praluent; Subcutaneous (SC) administration; Other Names: Alirocumab REGN727 SAR236553

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks [After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks]

   An AE is any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. AEs include serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of special interest (AESI). AESI include local injection site reactions, general allergic events, elevated alanine aminotransferase (ALT) levels greater than or equal to (≥) 3 upper limit normal (ULN) (if baseline is less than (<) ULN)/ALT ≥2 x ULN (if baseline ≥ ULN), neurologic events, neurocognitive events (according to Customized Medical Dictionary for Regulatory Activities [MedDRA] Query [CMQ] by Sponsor grouping and CMQ by FDA grouping), cataract, new onset diabetes (NOD), hepatic disorders, and diabetes mellitus (DM)/diabetic complications.

Secondary Outcome Measures

1. Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time [Up to week 72]

   The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

2. Percent Change in LDL-C From Baseline Over Time [Up to week 72]

3. Total Cholesterol (Total-C) Values From Baseline Over Time [Up to week 72]

   The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

4. Percent Change From Baseline in Total-C Over Time [Up to week 72]

5. Lipoprotein a (Lp(a)) Values From Baseline Over Time [Up to week 72]

   The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

6. Percent Change From Baseline in Lp(a) Over Time [Up to week 72]

7. Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time [Up to week 72]

   The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

8. Percent Change From Baseline in Non-HDL-C Over Time [Up to week 72]

9. High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time [Up to week 72]

   The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

10. Percent Change From Baseline in HDL-C Over Time [Up to week 72]

11. Fasting Triglycerides (TGs) Values From Baseline Over Time [Up to week 72]

    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

12. Percent Change From Baseline in Fasting TGs Over Time [Up to week 72]

13. Apolipoprotein B (Apo B) Values From Baseline Over Time [Up to week 72]

    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

14. Percent Change From Baseline in Apo B Over Time [Up to week 72]

15. Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time [Up to week 72]

    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

16. Percent Change From Baseline in Apo A1 Over Time [Up to week 72]

17. Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time [Up to week 72]

    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

18. Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time [Up to week 72]

19. Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time [Up to week 72]

    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

20. Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time [Up to week 72]

21. Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time [Up to week 72]

    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

22. Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time [Up to week 72]

23. Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time [Up to week 72]

    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

24. Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time [Up to week 72]

25. Alanine Aminotransferase Values From Baseline Over Time [Up to week 72]

    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

26. Change From Baseline in Alanine Aminotransferase Over Time [Up to week 72]

27. Aspartate Aminotransferase Values From Baseline Over Time [Up to week 72]

    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

28. Change From Baseline in Aspartate Aminotransferase Over Time [Up to week 72]

29. Alkaline Phosphatase Values From Baseline Over Time [Up to week 72]

    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

30. Change From Baseline in Alkaline Phosphatase Over Time [Up to week 72]

31. Total Bilirubin Values From Baseline Over Time [Up to week 72]

    The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)

32. Change From Baseline in Total Bilirubin Over Time [Up to week 72]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

Participants randomized into the neurocognitive function study (R727-CL-1532) who completed treatment and the end of study (EOS) visit with no premature or permanent discontinuation of study drug.

Key Exclusion Criteria:

1. Significant protocol deviation in the parent study (neurocognitive function study R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as noncompliance

2. Any participant who experienced an AE leading to permanent discontinuation from the neurocognitive function study R727-CL-1532 (NCT02957682).

3. Any new condition or worsening of an existing condition which, in the opinion of the investigator or per the PRALUENT local label, would make the participant unsuitable for enrollment or could interfere with the participant participating in or completing the open-label extension (OLE) study

4. Known hypersensitivity to monoclonal antibody or any component of the drug product

5. Pregnant or breastfeeding women

Note: Other inclusion/ exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regeneron Research Site	Auburn	Alabama	United States	36830
2	Regeneron Research Site	Mobile	Alabama	United States	36608
3	Regeneron Research Site	Beverly Hills	California	United States	90210
4	Regeneron Research Site	Los Gatos	California	United States	95032
5	Regeneron Research Site	North Hollywood	California	United States	91606
6	Regeneron Research Site	Port Hueneme	California	United States	93041
7	Regeneron Research Site	Aurora	Colorado	United States	80012
8	Regeneron Research Site	Colorado Springs	Colorado	United States	80906
9	Regeneron Research Site	Lake Worth	Florida	United States	33461
10	Regeneron Research Site	Miami Springs	Florida	United States	33166
11	Regeneron Research Site	Champaign	Illinois	United States	61822
12	Regeneron Research Site	Evansville	Indiana	United States	47714
13	Regeneron Research Site	Indianapolis	Indiana	United States	46237
14	Regeneron Research Site	Ames	Iowa	United States	50010-30144
15	Regeneron Research Site	Iowa City	Iowa	United States	52242
16	Regeneron Research Site	Waterloo	Iowa	United States	50702
17	Regeneron Research Site	Newton	Kansas	United States	67114
18	Regeneron Research Site	Louisville	Kentucky	United States	40213
19	Regeneron Research Site	Bangor	Maine	United States	04401
20	Regeneron Research Site	Baltimore	Maryland	United States	21229
21	Regeneron Research Site	Oxon Hill	Maryland	United States	20745
22	Regeneron Research Site	Olive Branch	Mississippi	United States	38654
23	Regeneron Research Site	Washington	Missouri	United States	63090
24	Regeneron Research Site	Buffalo	New York	United States	14215
25	Regeneron Research Site	New Hyde Park	New York	United States	11042
26	Regeneron Research Site	Cary	North Carolina	United States	27518
27	Regeneron Research Site	Charlotte	North Carolina	United States	28209
28	Regeneron Research Site	Charlotte	North Carolina	United States	28277
29	Regeneron Research Site	Greensboro	North Carolina	United States	27401
30	Regeneron Research Site	Hickory	North Carolina	United States	28601
31	Regeneron Research Site	Raleigh	North Carolina	United States	27609
32	Regeneron Research Site	Rocky Mount	North Carolina	United States	27804
33	Regeneron Research Site	Salisbury	North Carolina	United States	28144
34	Regeneron Research Site	Statesville	North Carolina	United States	28625
35	Regeneron Research Site	Wilmington	North Carolina	United States	28401
36	Regeneron Research Site	Winston-Salem	North Carolina	United States	27103
37	Regeneron Research Site	Cincinnati	Ohio	United States	45219
38	Regeneron Research Site	Cleveland	Ohio	United States	44122
39	Regeneron Research Site	Dayton	Ohio	United States	45414
40	Regeneron Research Site	Charleston	South Carolina	United States	29407
41	Regeneron Research Site	Summerville	South Carolina	United States	29485
42	Regeneron Research Site	Rapid City	South Dakota	United States	57701
43	Regeneron Research Site	Bristol	Tennessee	United States	37620
44	Regeneron Research Site 2	Knoxville	Tennessee	United States	37760
45	Regeneron Research Site 3	Knoxville	Tennessee	United States	37912
46	Regeneron Research Site	Knoxville	Tennessee	United States	37938
47	Regeneron Research Site	Powell	Tennessee	United States	37849
48	Regeneron Research Site	Dallas	Texas	United States	75231
49	Regeneron Research Site	Houston	Texas	United States	77027
50	Regeneron Research Site	Schertz	Texas	United States	78154
51	Regeneron Research Site	Shavano Park	Texas	United States	78213
52	Regeneron Research Site	Shavano Park	Texas	United States	78231
53	Regeneron Research Site	Falls Church	Virginia	United States	22042
54	Regeneron Research Site	Winchester	Virginia	United States	22601
55	Regeneron Research Site	Tacoma	Washington	United States	98405
56	Regeneron Research Site	Walla Walla	Washington	United States	99362
57	Regeneron Research Site	Manitowoc	Wisconsin	United States	54220
58	Regeneron Research Site	Pleven		Bulgaria	5800
59	Regeneron Research Site	Plovdiv		Bulgaria	4000
60	Regeneron Research Site	Sofia		Bulgaria	1309
61	Regeneron Research Site	Sofia		Bulgaria	1407
62	Regeneron Research Site #2	Sofia		Bulgaria	1784
63	Regeneron Research Site	Stara Zagora		Bulgaria	6000
64	Regeneron Research Site	Varna		Bulgaria	9000
65	Regeneron Research Site	Tallinn	Harjumaa	Estonia	10138
66	Regeneron Research Site	Paide		Estonia	72713
67	Regeneron Research Site #2	Tallinn		Estonia	10128
68	Regeneron Research Site	Tallinn		Estonia	10617
69	Regeneron Research Site	Tartu		Estonia	51014
70	Regeneron Research Site	Ekaterinburg		Russian Federation	620109
71	Regeneron Research Site	Ivanovo		Russian Federation	153012
72	Regeneron Research Site	Kirov		Russian Federation	610014
73	Regeneron Research Site	Moscow		Russian Federation	121309
74	Regeneron Research Site	Moscow		Russian Federation	121359
75	Regeneron Research Site	Moscow		Russian Federation	121552
76	Regeneron Research Site	Novosibirsk		Russian Federation	630008
77	Regeneron Research Site	Rostov-na-Donu		Russian Federation	344068
78	Regeneron Research Site	Saint Petersburg		Russian Federation	197376
79	Regeneron Research Site	Saint-Petersburg		Russian Federation	193312
80	Regeneron Research Site	Saint-Petersburg		Russian Federation	198205
81	Regeneron Research Site	Saratov		Russian Federation	410028
82	Regeneron Research Site #2	St. Petersburg		Russian Federation	192288
83	Regeneron Research Site	St. Petersburg		Russian Federation	192288
84	Regeneron Research Site	St. Petersburg		Russian Federation	195112
85	Regeneron Research Site	St. Petersburg		Russian Federation	197376
86	Regeneron Research Site	St. Petersburg		Russian Federation	197706
87	Regeneron Research Site	Sverdlovskaya		Russian Federation	620109
88	Regeneron Research Site	Tyumen		Russian Federation	625032
89	Regeneron Research Site 1	Yaroslavl		Russian Federation	150030
90	Regeneron Research Site 2	Yaroslavl		Russian Federation	150030
91	Regeneron Research Site	Kuilsrivier	Cape Town	South Africa	7580
92	Regeneron Research Site	Parow	Cape Town	South Africa	7500
93	Regeneron Research Site	Port Elizabeth	Eastern Cape	South Africa	6001
94	Regeneron Research Site	Halfway House	Gauteng	South Africa	1685
95	Regeneron Research Site	Pretoria West	Gauteng	South Africa	183
96	Regeneron Research Site	Pretoria	Gauteng	South Africa	0002
97	Regeneron Research Site	Pretoria	Gauteng	South Africa	0122
98	Regeneron Research Site	Pretoria	Gauteng	South Africa	0184
99	Regeneron Research Site	Kempton Park	Johannesburg	South Africa	1619
100	Regeneron Research Site	Soweto	Johannesburg	South Africa	1818
101	Regeneron Research Site	Cape Town	Western Cape	South Africa	7530
102	Regeneron Research Site	Cape Town	Western Cape	South Africa	7925
103	Regeneron Research Site	George	Western Cape	South Africa	6529
104	Regeneron Research Site	Paarl	Western Cape	South Africa	7646
105	Regeneron Research Site	Somerset West	Western Cape	South Africa	7130
106	Regeneron Research Site	Worcester	Western Cape	South Africa	6850
107	Regeneron Research Site	Bloemfontein		South Africa	9301
108	Regeneron Research Site	Claremont		South Africa	7708
109	Regeneron Research Site	Johannesburg		South Africa	2013
110	Regeneron Research Site #2	Kharkiv		Ukraine	61002
111	Regeneron Research Site	Kharkov		Ukraine	61039
112	Regeneron Research Site	Kiev		Ukraine	2091
113	Regeneron Research Site	Kyiv		Ukraine	02002
114	Regeneron Research Site	Kyiv		Ukraine	02660
115	Regeneron Research Site	Kyiv		Ukraine	03037
116	Regeneron Research Site	Kyiv		Ukraine	03049
117	Regeneron Research Site	Kyiv		Ukraine	03115
118	Regeneron Research Site #2	Kyiv		Ukraine	04114
119	Regeneron Research Site	Kyiv		Ukraine
120	Regeneron Research Site	Lviv		Ukraine	79015
121	Regeneron Research Site	Uzhorod		Ukraine	88000
122	Regeneron Research Site	Vinnitsa		Ukraine	21029
123	Regeneron Research Site	Vinnitsya		Ukraine	21018
124	Regeneron Research Site	Vinnytsya		Ukraine	21018

Sponsors and Collaborators

• Regeneron Pharmaceuticals
• Sanofi

Investigators

• Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

• Study Protocol - Sep 17, 2018
• Statistical Analysis Plan - Jul 17, 2020

More Information

Publications

None provided.

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03694197
• Other Study ID Numbers: R727-CL-1609; 2018-002810-11
• First Posted: Oct 3, 2018
• Last Update Posted: Jun 15, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia

Study Results

Participant Flow

Recruitment Details	The 1389 participants who completed double-blind treatment and the end-of-study (EOS) visit in R727-CL-1532 (NCT02957682) signed consent and were screened for this open-label study (EOS visit corresponded to day 1/visit 1 of this study).
Pre-assignment Detail	First subcutaneous (SC) injection was administered in the clinic (day 1/visit 1). Four of the1389 participants discontinued on day 1 before treatment: 2 discontinued due to failure to meet inclusion/exclusion criteria,1 withdrew consent, and 1 discontinued due to adverse event (AE). A total of 1385 participants received any study drug on day 1.

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Period Title: Overall Study
STARTED	1385
COMPLETED	0
NOT COMPLETED	1385

Baseline Characteristics

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Overall Participants	1385
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	64.6 (8.63)
Sex: Female, Male (Count of Participants)
Female	527 38.1%
Male	858 61.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 0.7%
Not Hispanic or Latino	1372 99.1%
Unknown or Not Reported	3 0.2%
Race/Ethnicity, Customized (Number) [Number]
White	1178 85.1%
Black or African American	81 5.8%
Asian	7 0.5%
American Indian or Alaska Native	1 0.1%
Native Hawaiian or Other Pacific Islander	0 0%
Other	118 8.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks
Description	An AE is any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. AEs include serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of special interest (AESI). AESI include local injection site reactions, general allergic events, elevated alanine aminotransferase (ALT) levels greater than or equal to (≥) 3 upper limit normal (ULN) (if baseline is less than (<) ULN)/ALT ≥2 x ULN (if baseline ≥ ULN), neurologic events, neurocognitive events (according to Customized Medical Dictionary for Regulatory Activities [MedDRA] Query [CMQ] by Sponsor grouping and CMQ by FDA grouping), cataract, new onset diabetes (NOD), hepatic disorders, and diabetes mellitus (DM)/diabetic complications.
Time Frame	After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks

Outcome Measure Data

Analysis Population Description

Safety analysis set (SAF): All participants who received any study drug

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Any treatment emergent adverse event (TEAE)	568 41%
Any treatment emergent serious adverse event (SAE)	89 6.4%
Any TEAE leading to death	5 0.4%
Any TEAE leading to permanent treatment discontinuation	9 0.6%
Any neurocognitive disorders TEAE (by Sponsor CMQ)	4 0.3%
Any neurocognitive disorders TEAE (by FDA CMQ)	0 0%
Any NOD; # analyzed = # of participants w/out diabetes at baseline	15 1.1%
Any hepatic disorders TEAE	14 1%
Any neurological TEAE	15 1.1%
Any general allergic TEAE	25 1.8%
At least one treatment-emergent injection site reaction	22 1.6%
Any cataract TEAE	5 0.4%
Any elevated ALT ≥3 ULN	1 0.1%
Any DM/diabetic complications TEAE; # analyzed = # of participants w/diabetes at baseline	41 3%
Any DM/diabetic complications TEAE; # analyzed = # of participants w/out diabetes at baseline	3 0.2%

2. Secondary Outcome

Title	Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time
Description	The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Baseline	117.8 (40.67)
Week 8	58.9 (37.31)
Week 12	63.6 (40.79)
Week 24	56.2 (36.59)
Week 48	56.8 (36.13)
Week 72	52.2 (38.80)

3. Secondary Outcome

Title	Percent Change in LDL-C From Baseline Over Time
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Week 8	-48.74 (31.121)
Week 12	-44.64 (35.338)
Week 24	-50.75 (30.249)
Week 48	-52.35 (27.929)
Week 72	-51.21 (32.742)

4. Secondary Outcome

Title	Total Cholesterol (Total-C) Values From Baseline Over Time
Description	The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Baseline	199.5 (48.88)
Week 8	139.5 (44.76)
Week 12	145.0 (48.68)
Week 24	137.3 (44.18)
Week 48	139.5 (44.53)
Week 72	131.7 (43.25)

5. Secondary Outcome

Title	Percent Change From Baseline in Total-C Over Time
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Week 8	-28.68 (20.158)
Week 12	-25.99 (23.058)
Week 24	-29.98 (20.930)
Week 48	-30.89 (21.004)
Week 72	-31.55 (22.238)

6. Secondary Outcome

Title	Lipoprotein a (Lp(a)) Values From Baseline Over Time
Description	The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Baseline	39.7 (47.86)
Week 8	35.0 (41.99)
Week 12	32.7 (39.42)
Week 24	33.9 (42.54)
Week 48	38.6 (50.66)
Week 72	40.4 (56.47)

7. Secondary Outcome

Title	Percent Change From Baseline in Lp(a) Over Time
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Week 8	-12.69 (35.452)
Week 12	10.63 (228.659)
Week 24	-6.80 (110.827)
Week 48	-7.89 (116.831)
Week 72	-22.23 (28.233)

8. Secondary Outcome

Title	Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time
Description	The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Baseline	152.4 (48.81)
Week 8	88.5 (43.54)
Week 12	94.3 (48.77)
Week 24	87.3 (43.56)
Week 48	88.9 (44.25)
Week 72	80.9 (42.67)

9. Secondary Outcome

Title	Percent Change From Baseline in Non-HDL-C Over Time
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Week 8	-40.35 (27.470)
Week 12	-36.89 (29.567)
Week 24	-41.47 (26.763)
Week 48	-42.33 (28.728)
Week 72	-43.28 (29.534)

10. Secondary Outcome

Title	High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time
Description	The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Baseline	47.1 (13.92)
Week 8	51.0 (14.82)
Week 12	50.6 (13.95)
Week 24	49.9 (14.80)
Week 48	50.5 (14.66)
Week 72	50.8 (14.61)

11. Secondary Outcome

Title	Percent Change From Baseline in HDL-C Over Time
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Week 8	10.54 (22.735)
Week 12	10.33 (21.933)
Week 24	8.53 (21.824)
Week 48	9.81 (23.690)
Week 72	9.24 (21.505)

12. Secondary Outcome

Title	Fasting Triglycerides (TGs) Values From Baseline Over Time
Description	The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Baseline	179.2 (146.51)
Week 8	154.8 (113.05)
Week 12	162.2 (182.00)
Week 24	169.3 (161.45)
Week 48	171.1 (131.35)
Week 72	156.9 (65.21)

13. Secondary Outcome

Title	Percent Change From Baseline in Fasting TGs Over Time
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Week 8	-4.68 (49.230)
Week 12	-4.29 (40.748)
Week 24	0.42 (54.118)
Week 48	1.54 (69.156)
Week 72	-5.97 (41.440)

14. Secondary Outcome

Title	Apolipoprotein B (Apo B) Values From Baseline Over Time
Description	The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Baseline	103.8 (27.25)
Week 8	62.5 (27.63)
Week 12	68.0 (31.32)
Week 24	61.5 (26.20)
Week 48	63.7 (26.40)
Week 72	58.5 (25.82)

15. Secondary Outcome

Title	Percent Change From Baseline in Apo B Over Time
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Week 8	-36.51 (34.460)
Week 12	-34.48 (27.905)
Week 24	-38.16 (24.867)
Week 48	-37.93 (23.767)
Week 72	-39.04 (26.383)

16. Secondary Outcome

Title	Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time
Description	The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Baseline	145.3 (24.95)
Week 8	148.5 (24.73)
Week 12	149.4 (25.38)
Week 24	150.7 (26.36)
Week 48	152.6 (25.96)
Week 72	151.4 (26.03)

17. Secondary Outcome

Title	Percent Change From Baseline in Apo A1 Over Time
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Week 8	5.07 (13.385)
Week 12	2.99 (13.638)
Week 24	5.35 (14.108)
Week 48	4.77 (13.836)
Week 72	1.21 (13.170)

18. Secondary Outcome

Title	Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time
Description	The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (Female participants who received any study drug); Here, "Number Analyzed" = Number of female participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	527
FSH Baseline	57.948 (26.7383)
FSH Week 8	59.264 (24.7912)
FSH Week 12	54.279 (23.9923)
FSH Week 24	57.664 (25.9830)
FSH Week 48	56.529 (25.1408)
FSH Week 72	58.600 (24.5205)
LH Baseline	30.155 (13.1090)
LH Week 8	33.794 (14.4459)
LH Week 12	30.779 (13.0946)
LH Week 24	31.260 (13.7344)
LH Week 48	29.585 (13.9792)
LH Week 72	29.248 (11.0829)

19. Secondary Outcome

Title	Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (Female participants who received any study drug); Here, "Number Analyzed" = Number of female participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	527
FSH Week 8	-0.765 (12.0083)
FSH Week 12	-0.984 (12.1584)
FSH Week 24	-0.575 (8.7780)
FSH Week 48	-0.877 (15.9972)
FSH Week 72	-1.861 (8.6119)
LH Week 8	2.730 (8.2258)
LH Week 12	1.882 (8.2884)
LH Week 24	0.939 (6.3694)
LH Week 48	0.367 (8.5631)
LH Week 72	0.222 (6.8910)

20. Secondary Outcome

Title	Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time
Description	The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (Male participants who received any study drug); Here, "Number Analyzed" = Number of male participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	858
FSH Baseline	8.006 (7.4451)
FSH Week 8	7.959 (7.5500)
FSH Week 12	7.766 (6.8204)
FSH Week 24	8.268 (8.1355)
FSH Week 48	9.597 (11.2138)
FSH Week 72	10.005 (13.2973)
LH Baseline	6.500 (4.2832)
LH Week 8	7.094 (4.7226)
LH Week 12	6.688 (4.4079)
LH Week 24	6.931 (4.8597)
LH Week 48	7.677 (6.5478)
LH Week 72	8.173 (8.9083)

21. Secondary Outcome

Title	Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (Male participants who received any study drug); Here, "Number Analyzed" = Number of male participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	858
FSH Week 8	0.285 (3.7264)
FSH Week 12	-0.598 (4.1076)
FSH Week 24	0.331 (6.0522)
FSH Week 48	0.960 (10.3803)
FSH Week 72	2.458 (13.4730)
LH Week 8	0.535 (2.4847)
LH Week 12	-0.136 (3.2638)
LH Week 24	0.582 (4.4964)
LH Week 48	1.015 (6.6344)
LH Week 72	1.964 (9.3028)

22. Secondary Outcome

Title	Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time
Description	The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (Female participants who received any study drug); Here, "Number Analyzed" = Number of female participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	527
Baseline	55.589 (80.8238)
Week 8	58.676 (69.0119)
Week 12	59.673 (74.7587)
Week 24	64.304 (103.8955)
Week 48	64.503 (102.1595)
Week 72	57.926 (67.1795)

23. Secondary Outcome

Title	Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (Female participants who received any study drug); Here, "Number Analyzed" = Number of female participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	527
Week 8	4.272 (77.1561)
Week 12	9.262 (73.1050)
Week 24	7.869 (78.4151)
Week 48	11.763 (97.5350)
Week 72	9.569 (38.0952)

24. Secondary Outcome

Title	Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time
Description	The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (Male participants who received any study drug); Here, "Number Analyzed" = Number of male participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	858
Baseline	13.4370 (6.36321)
Week 8	14.5802 (5.99821)
Week 12	14.2443 (6.77070)
Week 24	13.5818 (6.11269)
Week 48	13.4798 (7.04977)
Week 72	12.7538 (6.37408)

25. Secondary Outcome

Title	Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (Male participants who received any study drug); Here, "Number Analyzed" = Number of male participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	858
Week 8	0.6030 (4.46401)
Week 12	0.7965 (4.74765)
Week 24	0.1946 (5.89220)
Week 48	0.0498 (6.34201)
Week 72	1.2569 (5.29335)

26. Secondary Outcome

Title	Alanine Aminotransferase Values From Baseline Over Time
Description	The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Baseline	0.516 (0.3218)
Week 8	0.468 (0.2745)
Week 12	0.505 (0.4940)
Week 24	0.493 (0.2851)
Week 48	0.533 (0.3267)
Week 72	0.468 (0.2340)

27. Secondary Outcome

Title	Change From Baseline in Alanine Aminotransferase Over Time
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Week 8	-0.025 (0.3006)
Week 12	0.009 (0.5189)
Week 24	-0.036 (0.3294)
Week 48	-0.027 (0.3052)
Week 72	-0.062 (0.1872)

28. Secondary Outcome

Title	Aspartate Aminotransferase Values From Baseline Over Time
Description	The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Baseline	0.553 (0.2516)
Week 8	0.520 (0.2536)
Week 12	0.527 (0.2698)
Week 24	0.544 (0.3071)
Week 48	0.565 (0.2773)
Week 72	0.556 (0.2256)

29. Secondary Outcome

Title	Change From Baseline in Aspartate Aminotransferase Over Time
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Week 8	-0.022 (0.2856)
Week 12	-0.017 (0.3004)
Week 24	-0.013 (0.2901)
Week 48	-0.019 (0.2390)
Week 72	-0.037 (0.1730)

30. Secondary Outcome

Title	Alkaline Phosphatase Values From Baseline Over Time
Description	The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Baseline	0.601 (0.1865)
Week 8	0.635 (0.2151)
Week 12	0.605 (0.1865)
Week 24	0.602 (0.2012)
Week 48	0.602 (0.2657)
Week 72	0.553 (0.1678)

31. Secondary Outcome

Title	Change From Baseline in Alkaline Phosphatase Over Time
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Week 8	0.009 (0.1371)
Week 12	0.013 (0.1203)
Week 24	0.006 (0.1152)
Week 48	0.024 (0.2333)
Week 72	-0.011 (0.1029)

32. Secondary Outcome

Title	Total Bilirubin Values From Baseline Over Time
Description	The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Baseline	10.76 (4.736)
Week 8	10.01 (4.123)
Week 12	10.26 (4.758)
Week 24	10.41 (4.922)
Week 48	10.06 (4.503)
Week 72	8.82 (3.770)

33. Secondary Outcome

Title	Change From Baseline in Total Bilirubin Over Time
Time Frame	Up to week 72

Outcome Measure Data

Analysis Population Description

SAF (All participants who received any study drug); Here, "Number Analyzed" = Number of participants evaluable at that timepoint

Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
Measure Participants	1385
Week 8	-0.37 (3.120)
Week 12	-0.44 (3.854)
Week 24	-0.48 (3.962)
Week 48	-0.05 (3.991)
Week 72	0.71 (2.152)

Adverse Events

Time Frame	Adverse events were recorded from the time of signed informed consent until the end of study, up to 80 weeks.
Adverse Event Reporting Description	Treatment-emergent adverse events (TEAEs) are reported. TEAEs are AEs that developed or worsened or became serious during the TEAE period (time from first dose of study drug to the last study visit).
Arm/Group Title	Alirocumab 75 Q2W/Up150 Q2W
Arm/Group Description	All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels.
All Cause Mortality
	Alirocumab 75 Q2W/Up150 Q2W
	Affected / at Risk (%)	# Events
Total	5/1385 (0.4%)
Serious Adverse Events
	Alirocumab 75 Q2W/Up150 Q2W
	Affected / at Risk (%)	# Events
Total	89/1385 (6.4%)
Cardiac disorders
Angina unstable	10/1385 (0.7%)	10
Angina pectoris	8/1385 (0.6%)	8
Atrial fibrillation	6/1385 (0.4%)	6
Acute myocardial infarction	5/1385 (0.4%)	5
Acute left ventricular failure	2/1385 (0.1%)	2
Cardiac failure congestive	2/1385 (0.1%)	2
Coronary artery disease	2/1385 (0.1%)	2
Arrhythmia	1/1385 (0.1%)	1
Cardiac failure	1/1385 (0.1%)	1
Cardiac failure acute	1/1385 (0.1%)	1
Cardiac failure chronic	1/1385 (0.1%)	1
Cardio-respiratory arrest	1/1385 (0.1%)	1
Cardiovascular insufficiency	1/1385 (0.1%)	1
Myocardial infarction	1/1385 (0.1%)	1
Myocardial ischaemia	1/1385 (0.1%)	1
Eye disorders
Cataract	1/1385 (0.1%)	2
Gastrointestinal disorders
Intestinal ischaemia	1/1385 (0.1%)	1
Pancreatitis	1/1385 (0.1%)	2
Pancreatitis chronic	1/1385 (0.1%)	1
Umbilical hernia	1/1385 (0.1%)	1
General disorders
Chest pain	3/1385 (0.2%)	3
Death	1/1385 (0.1%)	1
Non-cardiac chest pain	1/1385 (0.1%)	1
Hepatobiliary disorders
Cholelithiasis	1/1385 (0.1%)	1
Infections and infestations
Pneumonia	4/1385 (0.3%)	4
Abscess limb	1/1385 (0.1%)	1
Appendiceal abscess	1/1385 (0.1%)	1
Appendicitis perforated	1/1385 (0.1%)	1
Bronchitis	1/1385 (0.1%)	1
Cellulitis	1/1385 (0.1%)	1
Cholecystitis infective	1/1385 (0.1%)	1
Cystitis	1/1385 (0.1%)	1
Diverticulitis	1/1385 (0.1%)	1
Pneumonia staphylococcal	1/1385 (0.1%)	1
Pyelonephritis	1/1385 (0.1%)	1
Injury, poisoning and procedural complications
Arterial injury	1/1385 (0.1%)	1
Cartilage injury	1/1385 (0.1%)	1
Concussion	1/1385 (0.1%)	1
Electric shock	1/1385 (0.1%)	1
Fall	1/1385 (0.1%)	1
Femur fracture	1/1385 (0.1%)	1
Lower limb fracture	1/1385 (0.1%)	1
Traumatic haemorrhage	1/1385 (0.1%)	1
Metabolism and nutrition disorders
Diabetic metabolic decompensation	1/1385 (0.1%)	1
Hypomagnesaemia	1/1385 (0.1%)	1
Type 2 diabetes mellitus	1/1385 (0.1%)	1
Musculoskeletal and connective tissue disorders
Osteoarthritis	2/1385 (0.1%)	2
Muscle spasms	1/1385 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	2/1385 (0.1%)	2
Adenocarcinoma of colon	1/1385 (0.1%)	1
Basal cell carcinoma	1/1385 (0.1%)	1
Synovial sarcoma	1/1385 (0.1%)	1
Nervous system disorders
Cerebrovascular accident	2/1385 (0.1%)	2
Ischaemic stroke	2/1385 (0.1%)	2
Carotid artery disease	1/1385 (0.1%)	1
Carotid artery occlusion	1/1385 (0.1%)	1
Encephalopathy	1/1385 (0.1%)	1
Haemorrhagic transformation stroke	1/1385 (0.1%)	1
Psychiatric disorders
Bipolar disorder	1/1385 (0.1%)	1
Renal and urinary disorders
Nephrolithiasis	2/1385 (0.1%)	2
Ureterolithiasis	1/1385 (0.1%)	1
Reproductive system and breast disorders
Uterine polyp	1/1385 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/1385 (0.1%)	1
Bronchitis chronic	1/1385 (0.1%)	1
Dyspnoea	1/1385 (0.1%)	1
Paranasal cyst	1/1385 (0.1%)	1
Pulmonary embolism	1/1385 (0.1%)	1
Skin and subcutaneous tissue disorders
Diabetic foot	1/1385 (0.1%)	1
Urticaria	1/1385 (0.1%)	1
Vascular disorders
Hypertension	1/1385 (0.1%)	1
Hypertensive crisis	1/1385 (0.1%)	1
Hypertensive urgency	1/1385 (0.1%)	1
Orthostatic hypotension	1/1385 (0.1%)	1
Peripheral artery occlusion	1/1385 (0.1%)	1
Other (Not Including Serious) Adverse Events
	Alirocumab 75 Q2W/Up150 Q2W
	Affected / at Risk (%)	# Events
Total	0/1385 (0%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.