Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

• Sponsor: Regeneron Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02265952
• Collaborator: (none)
• Enrollment: 9
• Locations: 5
• Arm: 1
• Actual Duration (Months): 41.6
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This is an open-label, single-arm study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia (HoFH).

Condition or Disease	Intervention/Treatment	Phase
Homozygous Familial Hypercholesterolemia	Drug: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Single-Arm, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Single and Multiple Doses of REGN1500 in Patients With Homozygous Familial Hypercholesterolemia
• Actual Study Start Date: Feb 4, 2015
• Actual Primary Completion Date: Nov 21, 2016
• Actual Study Completion Date: Jul 23, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Open-label Open-label REGN1500

Drug: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC; Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.

Outcome Measures

Primary Outcome Measures

1. Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period [Baseline (Week 0) up to Week 4]

   Percent change was reported for low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.

Secondary Outcome Measures

1. Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period [Baseline (Week 0) up to Week 4]

   Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.

2. Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period [Week 2 to Week 4]

   Absolute change in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.

3. Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period [Week 2 to Week 4]

   Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.

4. Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period [Baseline (Week 0) up to Week 26]

   Absolute change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.

5. Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period [Baseline (Week 0) up to Week 26]

   Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.

6. Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period [Baseline (Week 26) up to Week 214]

   Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) up to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)

7. Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period [Baseline (Week 26) up to Week 214]

   Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) to week 214 in the OLE period. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)

8. Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period [Baseline (Week 0) up to Week 26]

   Absolute change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to Week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.

9. Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period [Baseline (Week 0) up to Week 26]

   Percent change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to week 26. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.

10. Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period [Baseline (Week 26) up to Week 214]

    Absolute changein Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline to week 214 in open label extension (OLE) period. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET = Early Termination; EOS = End of Study)

11. Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period [Baseline (Week 26) up to Week 214]

    Percent change was reported in Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 26) up to week 214 in OLE Period. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)

12. Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 0) in the Main Study Period [Baseline (Week 0) up to Week 26]

    Percentage of participants who achieved reduction in low-density lipoprotein cholesterol (LDL-C) of greater than or equal to (≥) 25 percent (%) from baseline in the main study period was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.

13. Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 26) in the Open Label Extension (OLE) Period [Baseline (Week 26) to Week 214]

    Percentage of participants who achieved a reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 25% from baseline (week 26) to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.

14. Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 0) in the Main Study Period [Baseline (Week 0) to Week 26]

    Percentage of participants who achieved a reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 50% from baseline (week 0) to week 26 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.

15. Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 26) in the Open Label Extension (OLE) Period [Baseline (Week 26) up to Week 214]

    Percentage of participants who achieved reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 50% from baseline (week 26) in the OLE period was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.

16. Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period [Baseline (Week 0) up to Week 26]

    Absolute change was reported in HDL-C, TG, and Apo A-1 from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period.

17. Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period [Baseline (Week 0) up to Week 26]

    Percent change was reported in HDL-C, TG, and Apo A-1 from baseline (week 0) up to week 26. HDL-C, TG, and Apo A-1 were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.

18. Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period [Baseline (Week 26) up to Week 214]

    Percent change was reported in HDL-C, TG and Apo A-1 from baseline (week 26) up to week 214. HDL-C, TG and Apo A-1 were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)

19. Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period [Baseline (Week 26) up to Week 214]

    Absolute change was reported in HDL-C, TG and Apo A-1 from baseline (week 26) up to week 214. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)

20. Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period [Baseline (Week 0) up to Week 16]

    Absolute change was reported in Apo CIII from baseline (week 0) up to week 16. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.

21. Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period [Baseline (Week 0) to Week 16]

    Percent change was reported in Apo CIII from baseline (week 0) up to week 16. Apo CIII was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Men and women ≥18 years of age at the time of the screening visit

2. Diagnosis of homozygous familial hypercholesterolemia (HoFH)

3. Willing to consistently maintain usual diet for the duration of the study

Exclusion Criteria:

1. Background medical lipid modifying therapy that has not been stable for at least 4 weeks (6 weeks for fibrates) prior to the screening visit

2. Having undergone lipid apheresis within 4 weeks prior to the screening visit

3. Use of another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) prior to the screening visit

4. Previous participation in any clinical trial of REGN1500

Note: The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Los Angeles	California	United States
2		Philadelphia	Pennsylvania	United States
3		Dallas	Texas	United States
4		Chicoutimi	Quebec	Canada
5		Amsterdam		Netherlands

Sponsors and Collaborators

• Regeneron Pharmaceuticals

Investigators

• Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

• Gaudet D, Gipe DA, Pordy R, Ahmad Z, Cuchel M, Shah PK, Chyu KY, Sasiela WJ, Chan KC, Brisson D, Khoury E, Banerjee P, Gusarova V, Gromada J, Stahl N, Yancopoulos GD, Hovingh GK. ANGPTL3 Inhibition in Homozygous Familial Hypercholesterolemia. N Engl J Med. 2017 Jul 20;377(3):296-297. doi: 10.1056/NEJMc1705994.

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02265952
• Other Study ID Numbers: R1500-CL-1331; 2016-000411-32
• First Posted: Oct 16, 2014
• Last Update Posted: Dec 9, 2019
• Last Verified: Dec 1, 2019

• Additional relevant MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia

Study Results

Participant Flow

Recruitment Details	The study was conducted at five sites in United States, Canada, and the Netherlands between 04 Feb 2015 and 23 Jul 2018. A total of 12 participants were screened in the study. Out of 12 participants, 9 participants received the study treatment.
Pre-assignment Detail	This study consisted of 2 screening periods: 1st for main study and 2nd for open label extension (OLE) period. Participants on stable background medical lipid-modifying therapy for at least 4 weeks prior to screening, or who didn't undergo lipid apheresis within 4 weeks prior to screening visit, were directly entered into a 2-week screening period.

Arm/Group Title	REGN1500 250 mg SC/15 mg/kg IV/450 mg SC	REGN1500 300 mg SC/20 mg/kg IV
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.	Participants received REGN1500 SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 [Day 1499]) after the last dose of study drug in the OLE treatment period.
Period Title: Main Study Period
STARTED	9	0
COMPLETED	9	0
NOT COMPLETED	0	0
Period Title: Main Study Period
STARTED	0	8
COMPLETED	0	0
NOT COMPLETED	0	8

Baseline Characteristics

Arm/Group Title	REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Overall Participants	9
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.9 (9.06)
Age, Customized (Number) [Number]
< 45 years	7 77.8%
≥ 45 to < 65 years	2 22.2%
≥ 65 to < 75 years	0 0%
< 75 years	0 0%
Sex: Female, Male (Count of Participants)
Female	4 44.4%
Male	5 55.6%
Ethnicity (Count of Participants)
Hispanic or Latino	3 33.3%
Not Hispanic or Latino	6 66.7%
Not Reported	0 0%
Race (Count of Participants)
White	7 77.8%
Black or African American	0 0%
Asian	0 0%
American Indian or Alaska Native	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Other	0 0%
Not Reported	2 22.2%
Baseline Low-Density Lipoprotein Cholesterol (LDL-C) (Milligram per Deciliter (mg/dL)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Milligram per Deciliter (mg/dL)]	376.0 (240.85)
Baseline High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	38.8 (14.24)
Baseline Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	392.1 (246.41)
Baseline Apolipoprotein B (Apo B) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	226.1 (131.70)
Baseline Apolipoprotein CIII (Apo CIII) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	7.976 (3.3747)
Baseline Triglyceride (TG) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	80.0 (41.20)
Baseline Lipoprotein(a) (Lp[a]) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	154.9 (109.25)
Baseline Total Cholesterol (Total -C) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	430.9 (235.60)
Baseline Apolipoprotein A-1 (Apo A-1) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	110.4 (23.74)

Outcome Measures

1. Secondary Outcome

Title	Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period
Description	Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time Frame	Baseline (Week 0) up to Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Measure Participants	9
Mean (Standard Deviation) [mg/dL]	-157.34 (89.590)

2. Primary Outcome

Title	Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period
Description	Percent change was reported for low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time Frame	Baseline (Week 0) up to Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Measure Participants	9
Mean (Standard Deviation) [Percent Change]	-49.17 (23.136)

3. Secondary Outcome

Title	Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period
Description	Absolute change in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time Frame	Week 2 to Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Measure Participants	9
Mean (Standard Deviation) [Milligram per Deciliter (mg/dL)]	-63.63 (50.970)

4. Secondary Outcome

Title	Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period
Description	Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time Frame	Week 2 to Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Measure Participants	9
Mean (Standard Deviation) [Percent Change]	-30.05 (18.503)

5. Secondary Outcome

Title	Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Description	Absolute change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time Frame	Baseline (Week 0) up to Week 26

Outcome Measure Data

Analysis Population Description

"n" = Number of participants who were evaluable for this endpoint at a given time point.

Arm/Group Title	REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Measure Participants	9
Change at Day 4 (n= 9)	-39.60 (41.677)
Change at Week 1 (n= 9)	-67.59 (46.041)
Change at Week 2 (n= 9)	-93.71 (86.504)
Change at Week 3 (n= 9)	-129.97 (90.533)
Change at Week 4 (n= 9)	-157.34 (89.590)
Change at Week 5 (n= 8)	-179.18 (101.260)
Change at Week 6 (n= 9)	-183.41 (111.313)
Change at Week 8 (n= 9)	-176.72 (118.441)
Change at Week 10 (n= 9)	-151.19 (78.164)
Change at Week 12 (n= 9)	-109.40 (74.108)
Change at Week 13 (n= 2)	-170.15 (105.288)
Change at Week 14 (n= 9)	-104.16 (78.954)
Change at Week 15 (n= 2)	-186.15 (119.147)
Change at Week 16 (n= 9)	-97.29 (179.016)
Change at Week 17 (n= 2)	-174.20 (103.803)
Change at Week 18 (n= 7)	-62.11 (167.004)
Change at Week 20 (n= 2)	-155.25 (79.832)
Change at Week 22 (n= 7)	-41.37 (169.432)
Change at Week 23 (n= 2)	-155.85 (78.984)
Change at Week 25 (n= 2)	-87.90 (23.900)
Change at Week 26 (n= 6)	-23.98 (152.794)

6. Secondary Outcome

Title	Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Description	Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time Frame	Baseline (Week 0) up to Week 26

Outcome Measure Data

Analysis Population Description

"n" = Number of participants who were evaluable for this endpoint at a given time point.

Arm/Group Title	REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Measure Participants	9
Percent change at Day 4 (n= 9)	-12.76 (11.086)
Percent change at Week 1 (n= 9)	-24.00 (21.078)
Percent change at Week 2 (n= 9)	-30.13 (24.402)
Percent change at Week 3 (n= 9)	-41.38 (24.986)
Percent change at Week 4 (n= 9)	-49.17 (23.136)
Percent change at Week 5 (n= 8)	-46.88 (14.507)
Percent change at Week 6 (n= 9)	-52.13 (14.768)
Percent change at Week 8 (n= 9)	-51.59 (17.910)
Percent change at Week 10 (n= 9)	-45.61 (13.839)
Percent change at Week 12 (n= 9)	-36.54 (19.281)
Percent change at Week 13 (n= 2)	-39.84 (10.753)
Percent change at Week 14 (n= 9)	-33.02 (18.538)
Percent change at Week 15 (n= 2)	-43.38 (12.814)
Percent change at Week 16 (n= 9)	-24.98 (25.441)
Percent change at Week 17 (n= 2)	-40.99 (9.950)
Percent change at Week 18 (n= 7)	-13.72 (28.424)
Percent change at Week 20 (n= 2)	-37.17 (5.503)
Percent change at Week 22 (n= 7)	-9.50 (38.456)
Percent change at Week 23 (n= 2)	-37.37 (5.217)
Percent change at Week 25 (n= 2)	-22.12 (2.537)
Percent change at Week 26 (n= 6)	-10.27 (25.806)

7. Secondary Outcome

Title	Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Description	Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) up to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)
Time Frame	Baseline (Week 26) up to Week 214

Outcome Measure Data

Analysis Population Description

"n" = Number of participants who were evaluable for this endpoint at a given time point.

Arm/Group Title	REGN1500 300 mg SC/20 mg/kg IV
Arm/Group Description	Participants received REGN1500 SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 [Day 1499]) after the last dose of study drug in the OLE treatment period.
Measure Participants	8
Change at Week 26 (n= 8)	261.34 (178.792)
Change at Week 27 (n= 8)	-58.73 (56.992)
Change at Week 28 (n= 8)	-88.16 (83.196)
Change at Week 29 (n= 8)	-116.20 (102.219)
Change at Week 30 (n= 7)	-87.80 (108.905)
Change at Week 31 (n= 8)	-144.99 (130.764)
Change at Week 32 (n= 8)	-159.16 (128.072)
Change at Week 34 (n= 8)	-128.38 (108.331)
Change at Week 36 (n= 8)	-105.94 (89.990)
Change at Week 38 (n= 8)	-79.98 (97.851)
Change at Week 39 (n= 6)	-138.28 (123.133)
Change at Week 40 (n= 6)	-127.13 (122.808)
Change at Week 41 (n= 6)	-163.28 (137.365)
Change at Week 42 (n= 6)	-142.65 (126.647)
Change at Week 44 (n= 8)	-140.36 (109.275)
Change at Week 46 (n= 8)	-123.25 (112.503)
Change at Week 50 (n= 8)	-106.61 (99.458)
Change at Week 54 (n= 8)	-13.38 (177.649)
Change at Week 58 (n= 6)	-48.27 (93.443)
Change at Week 70 (n= 4)	-117.93 (145.917)
Change at Week 82 (n= 4)	-63.88 (64.738)
Change at Week 94 (n= 1)	-369.90 (NA)
Change at Week 106 (n= 1)	-290.00 (NA)
Change at ET (n= 8)	-9.78 (64.930)
Change at EOS (n= 3)	95.63 (147.100)

8. Secondary Outcome

Title	Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Description	Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) to week 214 in the OLE period. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)
Time Frame	Baseline (Week 26) up to Week 214

Outcome Measure Data

Analysis Population Description

"n" = Number of participants who were evaluable for this endpoint at a given time point.

Arm/Group Title	REGN1500 300 mg SC/20 mg/kg IV
Arm/Group Description	Participants received REGN1500 SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 [Day 1499]) after the last dose of study drug in the OLE treatment period.
Measure Participants	8
Baseline (n= 8)	261.34 (178.792)
Percent change at Week 27 (n= 8)	-22.49 (16.520)
Percent change at Week 28 (n= 8)	-36.74 (20.931)
Percent change at Week 29 (n= 8)	-44.35 (20.817)
Percent change at Week 30 (n= 7)	-37.37 (31.297)
Percent change at Week 31 (n= 8)	-50.74 (20.147)
Percent change at Week 32 (n= 8)	-60.03 (18.502)
Percent change at Week 34 (n= 8)	-53.03 (22.130)
Percent change at Week 36 (n= 8)	-47.90 (21.623)
Percent change at Week 38 (n= 8)	-37.05 (25.341)
Percent change at Week 39 (n= 6)	-59.83 (22.220)
Percent change at Week 40 (n= 6)	-53.90 (20.970)
Percent change at Week 41 (n= 6)	-66.28 (18.555)
Percent change at Week 42 (n= 6)	-59.59 (18.950)
Percent change at Week 44 (n= 8)	-57.64 (18.599)
Percent change at Week 46 (n= 8)	-48.74 (19.717)
Percent change at Week 50 (n= 8)	-42.31 (23.194)
Percent change at Week 54 (n= 8)	-13.60 (44.339)
Percent change at Week 58 (n= 6)	-12.86 (27.645)
Percent change at Week 70 (n= 4)	-38.61 (36.151)
Percent change at Week 82 (n= 4)	-24.68 (30.789)
Percent change at Week 94 (n= 1)	-81.67 (NA)
Percent change at Week 106 (n= 1)	-64.03 (NA)
Percent change at ET (n= 8)	-17.65 (28.813)
Percent change at EOS (n= 3)	19.59 (40.976)

9. Secondary Outcome

Title	Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Description	Absolute change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to Week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time Frame	Baseline (Week 0) up to Week 26

Outcome Measure Data

Analysis Population Description

"n" = Number of participants who were evaluable for this endpoint at a given time point.

Arm/Group Title	REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Measure Participants	9
Apo B: Change at Week 2 (n = 9)	-53.0 (56.29)
Apo B: Change at Week 3 (n = 9)	-81.0 (54.97)
Apo B: Change at Week 4 (n = 9)	-96.3 (56.01)
Apo B: Change at Week 5 (n = 8)	-104.6 (61.43)
Apo B: Change at Week 6 (n = 9)	-100.7 (71.12)
Apo B: Change at Week 8 (n = 9)	-96.8 (67.36)
Apo B: Change at Week 12 (n = 9)	-60.0 (63.61)
Apo B: Change at Week 14 (n = 9)	-61.7 (64.18)
Apo B: Change at Week 16 (n = 9)	-62.6 (98.77)
Apo B: Change at Week 18 (n = 7)	-28.6 (80.58)
Apo B: Change at Week 20 (n = 2)	-114.0 (67.88)
Apo B: Change at Week 22 (n = 7)	-22.7 (77.82)
Apo B: Change at Week 23 (n = 2)	-119.0 (79.20)
Apo B: Change at Week 26 (n = 6)	-4.7 (68.52)
Non-HDL-C: Change at Day 4 (n = 9)	-44.61 (42.322)
Non-HDL-C: Change at Week 1 (n = 9)	-72.16 (46.480)
Non-HDL-C: Change at Week 2 (n = 9)	-97.12 (88.026)
Non-HDL-C: Change at Week 3 (n = 9)	-138.09 (91.574)
Non-HDL-C: Change at Week 4 (n = 9)	-165.64 (93.130)
Non-HDL-C: Change at Week 5 (n = 8)	-187.46 (104.826)
Non-HDL-C: Change at Week 6 (n = 9)	-191.20 (116.337)
Non-HDL-C: Change at Week 8 (n = 9)	-182.98 (121.701)
Non-HDL-C: Change at Week 10 (n = 9)	-156.98 (81.636)
Non-HDL-C: Change at Week 12 (n = 9)	-116.20 (77.582)
Non-HDL-C: Change at Week 13 (n = 2)	-180.25 (116.178)
Non-HDL-C: Change at Week 14 (n = 9)	-108.58 (83.773)
Non-HDL-C: Change at Week 15 (n = 2)	-196.85 (135.270)
Non-HDL-C: Change at Week 16 (n = 9)	-99.58 (186.796)
Non-HDL-C: Change at Week 17 (n = 2)	-185.40 (114.834)
Non-HDL-C: Change at Week 18 (n = 7)	-60.41 (169.805)
Non-HDL-C: Change at Week 20 (n = 2)	-161.90 (85.843)
Non-HDL-C: Change at Week 22 (n = 7)	-41.16 (175.121)
Non-HDL-C: Change at Week 23 (n = 2)	-163.25 (85.065)
Non-HDL-C: Change at Week 25 (n = 2)	-92.20 (29.981)
Non-HDL-C: Change at Week 26 (n = 6)	-25.47 (156.948)
Total-C: Change at Day 4 (n = 9)	-50.36 (41.860)
Total-C: Change at Week 1 (n = 9)	-81.99 (46.513)
Total-C: Change at Week 2 (n = 9)	-109.03 (86.365)
Total-C: Change at Week 3 (n = 9)	-154.10 (86.927)
Total-C: Change at Week 4 (n = 9)	-180.79 (87.304)
Total-C: Change at Week 5 (n = 8)	-199.11 (98.202)
Total-C: Change at Week 6 (n = 9)	-207.63 (107.187)
Total-C: Change at Week 8 (n = 9)	-195.18 (113.993)
Total-C: Change at Week 10 (n = 9)	-167.87 (76.914)
Total-C: Change at Week 12 (n = 9)	-122.94 (76.104)
Total-C: Change at Week 13 (n = 2)	-188.45 (113.349)
Total-C: Change at Week 14 (n = 9)	-114.68 (84.082)
Total-C: Change at Week 15 (n = 2)	-205.60 (136.047)
Total-C: Change at Week 16 (n = 9)	-105.24 (186.103)
Total-C: Change at Week 17 (n = 2)	-195.00 (111.157)
Total-C: Change at Week 18 (n = 7)	-63.27 (166.911)
Total-C: Change at Week 20 (n = 2)	-170.45 (78.135)
Total-C: Change at Week 22 (n = 7)	-41.30 (174.597)
Total-C: Change at Week 23 (n = 2)	-167.55 (80.539)
Total-C: Change at Week 25 (n = 2)	-90.15 (26.234)
Total-C: Change at Week 26 (n = 6)	-30.77 (156.736)
Lp(a): Change at Week 2 (n = 9)	-22.4 (30.18)
Lp(a): Change at Week 3 (n = 9)	-20.8 (30.11)
Lp(a): Change at Week 4 (n = 9)	-21.1 (28.29)
Lp(a): Change at Week 5 (n = 8)	-30.1 (24.91)
Lp(a): Change at Week 6 (n = 9)	-25.0 (31.40)
Lp(a): Change at Week 8 (n = 9)	-28.9 (23.81)
Lp(a): Change at Week 12 (n = 9)	-20.9 (16.30)
Lp(a): Change at Week 14 (n = 9)	-22.3 (21.01)
Lp(a): Change at Week 16 (n = 9)	-26.9 (38.97)
Lp(a): Change at Week 18 (n = 7)	-29.9 (29.27)
Lp(a): Change at Week 20 (n = 2)	-19.0 (46.67)
Lp(a): Change at Week 22 (n = 7)	-24.3 (37.53)
Lp(a): Change at Week 23 (n = 2)	-12.5 (19.09)
Lp(a): Change at Week 26 (n = 6)	-16.3 (37.90)

10. Secondary Outcome

Title	Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Description	Percent change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to week 26. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time Frame	Baseline (Week 0) up to Week 26

Outcome Measure Data

Analysis Population Description

"n" = Number of participants who were evaluable for this endpoint at a given time point.

Arm/Group Title	REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Measure Participants	9
Apo B: Percent change at Week 2 (n = 9)	-24.38 (20.959)
Apo B: Percent change at Week 3 (n = 9)	-38.63 (22.114)
Apo B: Percent change at Week 4 (n = 9)	-45.89 (18.222)
Apo B: Percent change at Week 5 (n = 8)	-42.28 (13.247)
Apo B: Percent change at Week 6 (n = 9)	-43.12 (14.716)
Apo B: Percent change at Week 8 (n = 9)	-42.66 (14.475)
Apo B: Percent change at Week 12 (n = 9)	-29.47 (21.736)
Apo B: Percent change at Week 14 (n = 9)	-27.42 (18.418)
Apo B: Percent change at Week 16 (n = 9)	-21.60 (24.970)
Apo B: Percent change at Week 18 (n = 7)	-7.63 (24.347)
Apo B: Percent change at Week 20 (n = 2)	-39.32 (6.481)
Apo B: Percent change at Week 22 (n = 7)	-8.07 (30.444)
Apo B: Percent change at Week 23 (n = 2)	-40.29 (10.089)
Apo B: Percent change at Week 26 (n = 6)	-2.03 (25.320)
Non-HDL-C: Percent change at Day 4 (n = 9)	-13.61 (10.721)
Non-HDL-C: Percent change at Week 1 (n = 9)	-24.12 (20.083)
Non-HDL-C: Percent change at Week 2 (n = 9)	-29.61 (23.406)
Non-HDL-C: Percent change at Week 3 (n = 9)	-41.62 (23.969)
Non-HDL-C: Percent change at Week 4 (n = 9)	-48.91 (22.257)
Non-HDL-C: Percent change at Week 5 (n = 8)	-46.61 (14.172)
Non-HDL-C: Percent change at Week 6 (n = 9)	-51.49 (14.344)
Non-HDL-C: Percent change at Week 8 (n = 9)	-50.65 (17.231)
Non-HDL-C: Percent change at Week 10 (n = 9)	-44.80 (13.148)
Non-HDL-C: Percent change at Week 12 (n = 9)	-36.40 (18.711)
Non-HDL-C: Percent change at Week 13 (n = 2)	-39.84 (11.313)
Non-HDL-C: Percent change at Week 14 (n = 9)	-32.71 (18.214)
Non-HDL-C: Percent change at Week 15 (n = 2)	-43.09 (14.482)
Non-HDL-C: Percent change at Week 16 (n = 9)	-24.22 (25.899)
Non-HDL-C: Percent change at Week 17 (n = 2)	-41.21 (10.455)
Non-HDL-C: Percent change at Week 18 (n = 7)	-12.70 (27.798)
Non-HDL-C: Percent change at Week 20 (n = 2)	-36.71 (5.471)
Non-HDL-C: Percent change at Week 22 (n = 7)	-9.43 (37.102)
Non-HDL-C: Percent change at Week 23 (n = 2)	-37.10 (5.138)
Non-HDL-C: Percent change at Week 25 (n = 2)	-21.86 (1.676)
Non-HDL-C: Percent change at Week 26 (n = 6)	-9.99 (25.292)
Total-C: Percent change at Day 4 (n = 9)	-13.18 (8.932)
Total-C: Percent change at Week 1 (n = 9)	-23.23 (16.602)
Total-C: Percent change at Week 2 (n = 9)	-29.14 (20.307)
Total-C: Percent change at Week 3 (n = 9)	-40.81 (21.011)
Total-C: Percent change at Week 4 (n = 9)	-46.95 (19.083)
Total-C: Percent change at Week 5 (n = 8)	-45.43 (12.909)
Total-C: Percent change at Week 6 (n = 9)	-50.68 (13.327)
Total-C: Percent change at Week 8 (n = 9)	-48.29 (15.556)
Total-C: Percent change at Week 10 (n = 9)	-42.15 (10.858)
Total-C: Percent change at Week 12 (n = 9)	-33.48 (16.136)
Total-C: Percent change at Week 13 (n = 2)	-38.98 (10.525)
Total-C: Percent change at Week 14 (n = 9)	-29.66 (15.759)
Total-C: Percent change at Week 15 (n = 2)	-42.01 (14.356)
Total-C: Percent change at Week 16 (n = 9)	-23.51 (25.208)
Total-C: Percent change at Week 17 (n = 2)	-40.59 (9.468)
Total-C: Percent change at Week 18 (n = 7)	-12.65 (26.105)
Total-C: Percent change at Week 20 (n = 2)	-36.28 (3.862)
Total-C: Percent change at Week 22 (n = 7)	-7.73 (33.729)
Total-C: Percent change at Week 23 (n = 2)	-35.50 (4.662)
Total-C: Percent change at Week 25 (n = 2)	-19.82 (1.459)
Total-C: Percent change at Week 26 (n = 6)	-10.05 (22.903)
Lp(a): Percent change at Week 2 (n = 9)	-11.64 (20.323)
Lp(a): Percent change at Week 3 (n = 9)	-12.25 (19.350)
Lp(a): Percent change at Week 4 (n = 9)	-10.85 (24.465)
Lp(a): Percent change at Week 5 (n = 8)	-23.79 (17.908)
Lp(a): Percent change at Week 6 (n = 9)	-17.12 (23.680)
Lp(a): Percent change at Week 8 (n = 9)	-17.24 (17.764)
Lp(a): Percent change at Week 12 (n = 9)	-13.09 (12.614)
Lp(a): Percent change at Week 14 (n = 9)	-13.54 (10.151)
Lp(a): Percent change at Week 16 (n = 9)	-16.93 (24.795)
Lp(a): Percent change at Week 18 (n = 7)	-19.61 (21.686)
Lp(a): Percent change at Week 20 (n = 2)	-19.72 (32.894)
Lp(a): Percent change at Week 22 (n = 7)	-10.37 (29.230)
Lp(a): Percent change at Week 23 (n = 2)	-10.62 (15.373)
Lp(a): Percent change at Week 26 (n = 6)	3.46 (39.400)

11. Secondary Outcome

Title	Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Description	Absolute changein Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline to week 214 in open label extension (OLE) period. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET = Early Termination; EOS = End of Study)
Time Frame	Baseline (Week 26) up to Week 214

Outcome Measure Data

Analysis Population Description

"n" = Number of participants who were evaluable for this endpoint at a given time point.

Arm/Group Title	REGN1500 300 mg SC/20 mg/kg IV
Arm/Group Description	Participants received REGN1500 SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 [Day 1499]) after the last dose of study drug in the OLE treatment period.
Measure Participants	8
Apo B: Change at Week 30 (n= 7)	-48.1 (61.41)
Apo B: Change at Week 34 (n= 8)	-65.9 (58.96)
Apo B: Change at Week 38 (n= 8)	-40.9 (56.34)
Apo B: Change at Week 42 (n= 6)	-79.5 (71.19)
Apo B: Change at Week 44 (n= 8)	-78.6 (58.93)
Apo B: Change at Week 50 (n= 8)	-57.8 (50.82)
Apo B: Change at Week 70 (n= 4)	-60.3 (78.24)
Apo B: Change at Week 82 (n= 4)	-38.0 (35.66)
Apo B: Change at Week 94 (n= 1)	-212.0 (NA)
Apo B: Change at Week 106 (n= 1)	-173.0 (NA)
Apo B: Change at ET (n= 8)	-3.5 (42.88)
Apo B: Change at EOS (n= 3)	65.0 (100.53)
Non- HDL-C: Change at Week 27 (n= 8)	-65.06 (61.756)
Non- HDL-C: Change at Week 28 (n= 8)	-95.65 (87.499)
Non- HDL-C: Change at Week 29 (n= 8)	-122.94 (106.296)
Non- HDL-C: Change at Week 30 (n= 7)	-94.33 (113.286)
Non- HDL-C: Change at Week 31 (n= 8)	-152.98 (135.977)
Non- HDL-C: Change at Week 32 (n= 8)	-166.94 (133.990)
Non- HDL-C: Change at Week 34 (n= 8)	-133.69 (112.247)
Non- HDL-C: Change at Week 36 (n= 8)	-111.06 (93.635)
Non- HDL-C: Change at Week 38 (n= 8)	-84.16 (101.210)
Non- HDL-C: Change at Week 39 (n= 6)	-146.35 (128.368)
Non- HDL-C: Change at Week 40 (n= 6)	-134.50 (128.198)
Non- HDL-C: Change at Week 41 (n= 6)	-171.25 (143.692)
Non- HDL-C:Change at Week 42 (n= 6)	-150.28 (132.214)
Non- HDL-C: Change at Week 44 (n= 8)	-149.00 (114.152)
Non- HDL-C: Change at Week 46 (n= 8)	-129.99 (116.770)
Non- HDL-C: Change at Week 50 (n= 8)	-110.83 (104.353)
Non- HDL-C: Change at Week 54 (n= 8)	-14.79 (178.797)
Non- HDL-C: Change at Week 58 (n= 6)	-49.13 (97.212)
Non- HDL-C: Change at Week 70 (n= 4)	-121.83 (152.887)
Non- HDL-C: Change at Week 82 (n= 4)	-69.00 (66.715)
Non- HDL-C: Change at Week 94 (n= 1)	-388.10 (NA)
Non- HDL-C: Change at Week 106 (n= 1)	-303.10 (NA)
Non- HDL-C: Change at ET (n= 8)	-12.45 (64.513)
Non- HDL-C: Change at EOS (n= 3)	102.07 (153.301)
Total-C: Change at Week 27 (n= 8)	-73.80 (60.737)
Total-C: Change at Week 28 (n= 8)	-107.78 (83.051)
Total-C: Change at Week 29 (n= 8)	-134.33 (102.667)
Total-C: Change at Week 30 (n= 7)	-107.61 (109.689)
Total-C: Change at Week 31 (n= 8)	-166.85 (130.925)
Total-C: Change at Week 32 (n= 8)	-181.09 (130.048)
Total-C: Change at Week 34 (n= 8)	-148.90 (106.534)
Total-C: Change at Week 36 (n= 8)	-125.14 (89.065)
Total-C: Change at Week 38 (n= 8)	-93.00 (99.558)
Total-C: Change at Week 39 (n= 6)	-160.38 (125.452)
Total-C: Change at Week 40 (n= 6)	-150.42 (124.695)
Total-C: Change at Week 41 (n= 6)	-188.42 (141.249)
Total-C: Change at Week 42 (n= 6)	-166.80 (128.247)
Total-C: Change at Week 44 (n= 8)	-164.68 (110.222)
Total-C: Change at Week 46 (n= 8)	-144.69 (110.682)
Total-C: Change at Week 50 (n= 8)	-123.04 (99.299)
Total-C: Change at Week 54 (n= 8)	-23.80 (180.982)
Total-C: Change at Week 58 (n= 6)	-54.45 (97.160)
Total-C: Change at Week 70 (n= 4)	-132.55 (152.664)
Total-C: Change at Week 82 (n= 4)	-75.43 (67.802)
Total-C: Change at Week 94 (n= 1)	-392.30 (NA)
Total-C: Change at Week 106 (n= 1)	-303.10 (NA)
Total-C: Change at ET (n= 8)	-20.38 (68.809)
Total-C: Change at EOS (n= 3)	100.40 (144.828)
Lp(a): Change at Week 30 (n= 7)	-9.0 (27.59)
Lp(a): Change at Week 34 (n= 8)	-10.8 (24.00)
Lp(a): Change at Week 38 (n= 8)	-16.0 (19.70)
Lp(a): Change at Week 42 (n= 6)	-0.8 (41.36)
Lp(a): Change at Week 44 (n= 8)	1.5 (37.73)
Lp(a): Change at Week 50 (n= 8)	11.6 (48.23)
Lp(a): Change at Week 70 (n= 4)	36.8 (77.92)
Lp(a): Change at Week 82 (n= 4)	-5.3 (27.04)
Lp(a): Change at Week 94 (n= 1)	-18.0 (NA)
Lp(a): Change at Week 106 (n= 1)	39.0 (NA)
Lp(a): Change at Week ET (n= 8)	11.6 (26.72)
Lp(a): Change at EOS (n= 3)	18.3 (18.01)

12. Secondary Outcome

Title	Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Description	Percent change was reported in Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 26) up to week 214 in OLE Period. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)
Time Frame	Baseline (Week 26) up to Week 214

Outcome Measure Data

Analysis Population Description

"n" = Number of participants who were evaluable for this endpoint at a given time point.

Arm/Group Title	REGN1500 300 mg SC/20 mg/kg IV
Arm/Group Description	Participants received REGN1500 SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 [Day 1499]) after the last dose of study drug in the OLE treatment period.
Measure Participants	8
Apo B: Percent change at Week 30 (n= 7)	-30.59 (25.991)
Apo B: Percent change at Week 34 (n= 8)	-41.27 (19.573)
Apo B: Percent change at Week 38 (n= 8)	-29.02 (25.029)
Apo B: Percent change at Week 42 (n= 6)	-50.90 (17.497)
Apo B: Percent change at Week 44 (n= 8)	-48.59 (16.201)
Apo B: Percent change at Week 50 (n= 8)	-36.68 (19.620)
Apo B: Percent change at Week 70 (n= 4)	-33.44 (26.773)
Apo B: Percent change at Week 82 (n= 4)	-24.87 (17.148)
Apo B: Percent change at Week 94 (n= 1)	-77.09 (NA)
Apo B: Percent change at Week 106 (n= 1)	-62.91 (NA)
Apo B: Percent change at ET (n= 8)	-11.94 (25.708)
Apo B: Percent change at EOS (n= 3)	22.60 (38.988)
Non- HDL-C: Percent change at Week 27 (n= 8)	-23.62 (15.342)
Non- HDL-C: Percent change at Week 28 (n= 8)	-37.22 (19.207)
Non- HDL-C: Percent change at Week 29 (n= 8)	-44.30 (19.766)
Non- HDL-C: Percent change at Week 30 (n= 7)	-37.90 (29.133)
Non- HDL-C: Percent change at Week 31 (n= 8)	-50.59 (19.285)
Non- HDL-C: Percent change at Week 32 (n= 8)	-59.09 (18.200)
Non- HDL-C: Percent change at Week 34 (n= 8)	-51.55 (21.112)
Non- HDL-C: Percent change at Week 36 (n= 8)	-46.62 (20.797)
Non- HDL-C: Percent change at Week 38 (n= 8)	-36.10 (24.473)
Non- HDL-C: Percent change at Week 39 (n= 6)	-59.25 (21.381)
Non- HDL-C: Percent change at Week 40 (n= 6)	-53.24 (20.135)
Non- HDL-C: Percent change at Week 41 (n= 6)	-65.07 (18.375)
Non- HDL-C: Percent change at Week 42 (n= 6)	-58.92 (18.287)
Non- HDL-C: Percent change at Week 44 (n= 8)	-57.03 (17.675)
Non- HDL-C: Percent change at Week 46 (n= 8)	-48.27 (18.674)
Non- HDL-C: Percent change at Week 50 (n= 8)	-41.16 (22.284)
Non- HDL-C: Percent change at Week 54 (n= 8)	-12.93 (42.412)
Non- HDL-C: Percent change at Week 58 (n= 6)	-12.28 (26.060)
Non- HDL-C: Percent change at Week 70 (n= 4)	-37.68 (35.771)
Non- HDL-C: Percent change at Week 82 (n= 4)	-26.16 (27.153)
Non- HDL-C: Percent change at Week 94 (n= 1)	-81.52 (NA)
Non- HDL-C: Percent change at Week 106 (n= 1)	-63.66 (NA)
Non- HDL-C: Percent change at ET (n= 8)	-17.65 (27.339)
Non- HDL-C: Percent change at EOS (n= 3)	19.98 (40.313)
Total-C: Percent change at Week 27 (n= 8)	-22.24 (11.566)
Total-C: Percent change at Week 28 (n= 8)	-34.78 (14.984)
Total-C: Percent change at Week 29 (n= 8)	-40.57 (14.335)
Total-C: Percent change at Week 30 (n= 7)	-36.37 (23.550)
Total-C: Percent change at Week 31 (n= 8)	-48.83 (16.944)
Total-C: Percent change at Week 32 (n= 8)	-55.05 (16.624)
Total-C: Percent change at Week 34 (n= 8)	-48.67 (18.123)
Total-C: Percent change at Week 36 (n= 8)	-44.16 (19.175)
Total-C: Percent change at Week 38 (n= 8)	-33.29 (22.145)
Total-C: Percent change at Week 39 (n= 6)	-54.40 (19.803)
Total-C: Percent change at Week 40 (n= 6)	-50.13 (18.316)
Total-C: Percent change at Week 41 (n= 6)	-60.87 (17.966)
Total-C: Percent change at Week 42 (n= 6)	-54.88 (15.886)
Total-C: Percent change at Week 44 (n= 8)	-53.41 (16.231)
Total-C: Percent change at Week 46 (n= 8)	-46.06 (16.855)
Total-C: Percent change at Week 50 (n= 8)	-39.04 (19.318)
Total-C: Percent change at Week 54 (n= 8)	-12.82 (38.323)
Total-C: Percent change at Week 58 (n= 6)	-13.78 (21.976)
Total-C: Percent change at Week 70 (n= 4)	-36.63 (32.371)
Total-C: Percent change at Week 82 (n= 4)	-23.09 (19.171)
Total-C: Percent change at Week 94 (n= 1)	-77.50 (NA)
Total-C: Percent change at Week 106 (n= 1)	-59.88 (NA)
Total-C: Percent change at ET (n= 8)	-16.76 (25.085)
Total-C: Percent change at EOS (n= 3)	18.20 (33.900)
Lp(a): Percent change at Week 30 (n= 7)	-3.57 (24.610)
Lp(a): Percent change at Week 34 (n= 8)	-6.43 (21.281)
Lp(a): Percent change at Week 38 (n= 8)	-9.50 (14.429)
Lp(a): Percent change at Week 42 (n= 6)	-4.76 (24.227)
Lp(a): Percent change at Week 44 (n= 8)	-5.13 (25.377)
Lp(a): Percent change at Week 50 (n= 8)	1.02 (29.756)
Lp(a): Percent change at Week 70 (n= 4)	15.80 (36.280)
Lp(a): Percent change at Week 82 (n= 4)	-3.77 (16.168)
Lp(a): Percent change at Week 94 (n= 1)	-11.92 (NA)
Lp(a): Percent change at Week 106 (n= 1)	25.83 (NA)
Lp(a): Percent change at ET (n= 8)	9.96 (21.597)
Lp(a): Percent change at EOS (n= 3)	40.51 (39.616)

13. Secondary Outcome

Title	Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 0) in the Main Study Period
Description	Percentage of participants who achieved reduction in low-density lipoprotein cholesterol (LDL-C) of greater than or equal to (≥) 25 percent (%) from baseline in the main study period was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time Frame	Baseline (Week 0) up to Week 26

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Measure Participants	9
Number [Percentage of participants]	100 1111.1%

14. Secondary Outcome

Title	Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 26) in the Open Label Extension (OLE) Period
Description	Percentage of participants who achieved a reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 25% from baseline (week 26) to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time Frame	Baseline (Week 26) to Week 214

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	REGN1500 300 mg SC/20 mg/kg IV
Arm/Group Description	Participants received REGN1500 SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 [Day 1499]) after the last dose of study drug in the OLE treatment period.
Measure Participants	8
Number [Percentage of participants]	100 1111.1%

15. Secondary Outcome

Title	Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 0) in the Main Study Period
Description	Percentage of participants who achieved a reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 50% from baseline (week 0) to week 26 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time Frame	Baseline (Week 0) to Week 26

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Measure Participants	9
Number [Percentage of participants]	77.8 864.4%

16. Secondary Outcome

Title	Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 26) in the Open Label Extension (OLE) Period
Description	Percentage of participants who achieved reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 50% from baseline (week 26) in the OLE period was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time Frame	Baseline (Week 26) up to Week 214

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	REGN1500 300 mg SC/20 mg/kg IV
Arm/Group Description	Participants received REGN1500 SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 [Day 1499]) after the last dose of study drug in the OLE treatment period.
Measure Participants	8
Number [Percentage]	87.5

17. Secondary Outcome

Title	Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Description	Absolute change was reported in HDL-C, TG, and Apo A-1 from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period.
Time Frame	Baseline (Week 0) up to Week 26

Outcome Measure Data

Analysis Population Description

"n" = Number of participants who were evaluable for this endpoint at a given time point.

Arm/Group Title	REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Measure Participants	9
HDL-C: Change at Day 4 (n = 9)	-5.81 (4.789)
HDL-C: Change at Week 1 (n = 9)	-9.92 (6.578)
HDL-C: Change at Week 2 (n = 9)	-11.99 (7.351)
HDL-C: Change at Week 3 (n = 9)	-16.02 (10.737)
HDL-C: Change at Week 4 (n = 9)	-15.07 (10.792)
HDL-C: Change at Week 5 (n = 8)	-11.66 (8.442)
HDL-C: Change at Week 6 (n = 9)	-16.46 (11.868)
HDL-C: Change at Week 8 (n = 9)	-12.06 (11.334)
HDL-C: Change at Week 10 (n = 9)	-10.94 (8.215)
HDL-C: Change at Week 12 (n = 9)	-6.82 (6.811)
HDL-C: Change at Week 13 (n = 2)	-8.10 (2.970)
HDL-C: Change at Week 14 (n = 9)	-6.18 (4.205)
HDL-C: Change at Week 15 (n = 2)	-8.70 (0.566)
HDL-C: Change at Week 16 (n = 9)	-5.54 (5.785)
HDL-C: Change at Week 17 (n = 2)	-9.40 (3.818)
HDL-C: Change at Week 18 (n = 7)	-2.93 (7.435)
HDL-C: Change at Week 20 (n = 2)	-8.70 (8.202)
HDL-C: Change at Week 22 (n = 7)	-0.30 (6.943)
HDL-C: Change at Week 23 (n = 2)	-4.00 (4.384)
HDL-C: Change at Week 25 (n = 2)	2.50 (3.818)
HDL-C: Change at Week 26 (n = 6)	-5.30 (5.266)
TG: Change at Day 4 (n = 9)	-25.17 (18.545)
TG: Change at Week 1 (n = 9)	-21.41 (17.603)
TG: Change at Week 2 (n = 9)	-15.83 (15.908)
TG: Change at Week 3 (n = 9)	-39.73 (31.977)
TG: Change at Week 4 (n = 9)	-40.81 (30.277)
TG: Change at Week 5 (n = 8)	-42.04 (28.887)
TG: Change at Week 6 (n = 9)	-38.73 (35.120)
TG: Change at Week 8 (n = 9)	-30.37 (26.383)
TG: Change at Week 10 (n = 9)	-28.79 (21.095)
TG: Change at Week 12 (n = 9)	-33.23 (32.901)
TG: Change at Week 13 (n = 2)	-49.15 (56.922)
TG: Change at Week 14 (n = 9)	-22.11 (35.348)
TG: Change at Week 15 (n = 2)	-52.20 (82.590)
TG: Change at Week 16 (n = 9)	-11.20 (48.136)
TG: Change at Week 17 (n = 2)	-55.35 (58.195)
TG: Change at Week 18 (n = 7)	9.77 (24.537)
TG: Change at Week 20 (n = 2)	-33.65 (33.729)
TG: Change at Week 22 (n = 7)	1.90 (33.916)
TG: Change at Week 23 (n = 2)	-36.30 (31.254)
TG: Change at Week 25 (n = 2)	-23.45 (34.436)
TG: Change at Week 26 (n = 6)	-5.87 (28.748)
Apo A-1: Change at Week 2 (n = 9)	-28.6 (18.64)
Apo A-1: Change at Week 3 (n = 9)	-43.3 (22.54)
Apo A-1: Change at Week 4 (n = 9)	-43.4 (16.88)
Apo A-1: Change at Week 5 (n = 8)	-35.8 (17.53)
Apo A-1: Change at Week 6 (n = 9)	-40.7 (19.86)
Apo A-1: Change at Week 8 (n = 9)	-33.6 (20.64)
Apo A-1: Change at Week 12 (n = 9)	-17.2 (20.04)
Apo A-1: Change at Week 14 (n = 9)	-17.7 (11.97)
Apo A-1: Change at Week 16 (n = 9)	-11.3 (16.50)
Apo A-1: Change at Week 18 (n = 7)	-4.9 (17.72)
Apo A-1: Change at Week 20 (n = 2)	-24.0 (8.49)
Apo A-1: Change at Week 22 (n = 7)	1.9 (15.42)
Apo A-1: Change at Week 23 (n = 2)	-23.0 (8.49)
Apo A-1: Change at Week 26 (n = 6)	-10.8 (13.83)

18. Secondary Outcome

Title	Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Description	Percent change was reported in HDL-C, TG, and Apo A-1 from baseline (week 0) up to week 26. HDL-C, TG, and Apo A-1 were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time Frame	Baseline (Week 0) up to Week 26

Outcome Measure Data

Analysis Population Description

"n" = Number of participants who were evaluable for this endpoint at a given time point.

Arm/Group Title	REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Measure Participants	9
HDL-C: Percent Change at Day 4 (n = 9)	-14.37 (10.830)
HDL-C: Percent Change at Week 1 (n = 9)	-23.34 (10.783)
HDL-C: Percent Change at Week 2 (n = 9)	-28.75 (8.458)
HDL-C: Percent Change at Week 3 (n = 9)	-36.96 (16.495)
HDL-C: Percent Change at Week 4 (n = 9)	-35.24 (16.212)
HDL-C: Percent Change at Week 5 (n = 8)	-29.74 (14.240)
HDL-C: Percent Change at Week 6 (n = 9)	-37.88 (15.864)
HDL-C: Percent Change at Week 8 (n = 9)	-25.42 (23.199)
HDL-C: Percent Change at Week 10 (n = 9)	-24.57 (22.409)
HDL-C: Percent Change at Week 12 (n = 9)	-13.59 (23.189)
HDL-C: Percent Change at Week 13 (n = 2)	-24.48 (6.243)
HDL-C: Percent Change at Week 14 (n = 9)	-16.81 (14.822)
HDL-C: Percent Change at Week 15 (n = 2)	-26.97 (4.895)
HDL-C: Percent Change at Week 16 (n = 9)	-12.03 (16.026)
HDL-C: Percent Change at Week 17 (n = 2)	-28.34 (8.393)
HDL-C: Percent Change at Week 18 (n = 7)	-1.05 (24.171)
HDL-C: Percent Change at Week 20 (n = 2)	-25.39 (22.187)
HDL-C: Percent Change at Week 22 (n = 7)	3.78 (20.466)
HDL-C: Percent Change at Week 23 (n = 2)	-11.56 (12.094)
HDL-C: Percent Change at Week 25 (n = 2)	8.41 (12.698)
HDL-C: Percent Change at Week 26 (n = 6)	-12.00 (11.109)
TG: Percent Change at Day 4 (n = 9)	-29.61 (18.562)
TG: Percent Change at Week 1 (n = 9)	-23.41 (20.150)
TG: Percent Change at Week 2 (n = 9)	-17.19 (18.735)
TG: Percent Change at Week 3 (n = 9)	-44.38 (19.223)
TG: Percent Change at Week 4 (n = 9)	-46.57 (17.014)
TG: Percent Change at Week 5 (n = 8)	-44.49 (16.583)
TG: Percent Change at Week 6 (n = 9)	-40.03 (26.830)
TG: Percent Change at Week 8 (n = 9)	-30.69 (24.800)
TG: Percent Change at Week 10 (n = 9)	-31.40 (16.697)
TG: Percent Change at Week 12 (n = 9)	-35.38 (25.014)
TG: Percent Change at Week 13 (n = 2)	-35.11 (26.733)
TG: Percent Change at Week 14 (n = 9)	-23.51 (28.335)
TG: Percent Change at Week 15 (n = 2)	-27.77 (55.240)
TG: Percent Change at Week 16 (n = 9)	-6.70 (40.326)
TG: Percent Change at Week 17 (n = 2)	-42.09 (22.941)
TG: Percent Change at Week 18 (n = 7)	23.13 (55.349)
TG: Percent Change at Week 20 (n = 2)	-26.30 (11.945)
TG: Percent Change at Week 22 (n = 7)	8.86 (43.819)
TG: Percent Change at Week 23 (n = 2)	-30.58 (6.662)
TG: Percent Change at Week 25 (n = 2)	-13.62 (21.582)
TG: Percent Change at Week 26 (n = 6)	-1.60 (33.318)
Apo A-1: Percent Change at Week 2 (n = 9)	-24.37 (12.794)
Apo A-1: Percent Change at Week 3 (n = 9)	-36.47 (16.930)
Apo A-1: Percent Change at Week 4 (n = 9)	-38.54 (8.906)
Apo A-1: Percent Change at Week 5 (n = 8)	-31.91 (11.491)
Apo A-1: Percent Change at Week 6 (n = 9)	-34.72 (12.342)
Apo A-1: Percent Change at Week 8 (n = 9)	-29.03 (14.765)
Apo A-1: Percent Change at Week 12 (n = 9)	-11.85 (25.176)
Apo A-1: Percent Change at Week 14 (n = 9)	-17.65 (13.824)
Apo A-1: Percent Change at Week 16 (n = 9)	-9.86 (14.372)
Apo A-1: Percent Change at Week 18 (n = 7)	-1.16 (19.598)
Apo A-1: Percent Change at Week 20 (n = 2)	-22.15 (7.965)
Apo A-1: Percent Change at Week 22 (n = 7)	4.21 (17.857)
Apo A-1: Percent Change at Week 23 (n = 2)	-21.22 (7.959)
Apo A-1: Percent Change at Week 26 (n = 6)	-9.68 (11.250)

19. Secondary Outcome

Title	Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Description	Percent change was reported in HDL-C, TG and Apo A-1 from baseline (week 26) up to week 214. HDL-C, TG and Apo A-1 were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)
Time Frame	Baseline (Week 26) up to Week 214

Outcome Measure Data

Analysis Population Description

"n" = Number of participants who were evaluable for this endpoint at a given time point.

Arm/Group Title	REGN1500 300 mg SC/20 mg/kg IV
Arm/Group Description	Participants received REGN1500 SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 [Day 1499]) after the last dose of study drug in the OLE treatment period.
Measure Participants	8
HDL-C: Percent change at Week 27 (n= 8)	-21.47 (11.815)
HDL-C: Percent change at Week 28 (n= 8)	-27.60 (11.485)
HDL-C: Percent change at Week 29 (n= 8)	-26.51 (16.584)
HDL-C: Percent change at Week 30 (n= 7)	-27.57 (14.566)
HDL-C: Percent change at Week 31 (n= 8)	-32.81 (18.939)
HDL-C: Percent change at Week 32 (n= 8)	-32.72 (14.684)
HDL-C: Percent change at Week 34 (n= 8)	-34.60 (15.971)
HDL-C: Percent change at Week 36 (n= 8)	-31.14 (18.695)
HDL-C: Percent change at Week 38 (n= 8)	-18.57 (15.411)
HDL-C: Percent change at Week 39 (n= 6)	-32.09 (16.062)
HDL-C: Percent change at Week 40 (n= 6)	-36.25 (9.327)
HDL-C: Percent change at Week 41 (n= 6)	-39.14 (13.804)
HDL-C: Percent change at Week 42 (n= 6)	-38.31 (10.670)
HDL-C: Percent change at Week 44 (n= 8)	-37.01 (12.049)
HDL-C: Percent change at Week 46 (n= 8)	-32.77 (13.829)
HDL-C: Percent change at Week 50 (n= 8)	-25.17 (17.957)
HDL-C: Percent change at Week 54 (n= 8)	-20.16 (18.657)
HDL-C: Percent change at Week 58 (n= 6)	-10.87 (14.194)
HDL-C: Percent change at Week 70 (n= 4)	-24.67 (15.473)
HDL-C: Percent change at Week 82 (n= 4)	-17.56 (10.574)
HDL-C: Percent change at Week 94 (n= 1)	-13.95 (NA)
HDL-C: Percent change at Week 106 (n= 1)	0.00 (NA)
HDL-C: Percent change at ET (n= 8)	-15.08 (21.569)
HDL-C: Percent change at EOS (n= 3)	-0.78 (27.385)
Triglycerides: Percent change at Week 27 (n= 8)	-38.62 (26.036)
Triglycerides: Percent change at Week 28 (n= 8)	-41.76 (27.247)
Triglycerides: Percent change at Week 29 (n= 8)	-41.17 (18.721)
Triglycerides: Percent change at Week 30 (n= 7)	-38.82 (23.649)
Triglycerides: Percent change at Week 31 (n= 8)	-44.86 (28.212)
Triglycerides: Percent change at Week 32 (n= 8)	-45.33 (23.671)
Triglycerides: Percent change at Week 34 (n= 8)	-28.58 (23.643)
Triglycerides: Percent change at Week 36 (n= 8)	-25.89 (36.606)
Triglycerides: Percent change at Week 38 (n= 8)	-24.32 (25.386)
Triglycerides: Percent change at Week 39 (n= 6)	-48.37 (26.457)
Triglycerides: Percent change at Week 40 (n= 6)	-43.36 (26.527)
Triglycerides: Percent change at Week 41 (n= 6)	-46.65 (25.386)
Triglycerides: Percent change at Week 42 (n= 6)	-43.09 (29.631)
Triglycerides: Percent change at Week 44 (n= 8)	-47.98 (35.076)
Triglycerides: Percent change at Week 46 (n= 8)	-37.64 (26.234)
Triglycerides: Percent change at Week 50 (n= 8)	-22.10 (27.247)
Triglycerides: Percent change at Week 54 (n= 8)	-1.08 (30.518)
Triglycerides: Percent change at Week 58 (n= 6)	3.72 (25.130)
Triglycerides: Percent change at Week 70 (n= 4)	-22.28 (31.761)
Triglycerides: Percent change at Week 82 (n= 4)	-36.47 (9.998)
Triglycerides: Percent change at Week 94 (n= 1)	-76.36 (NA)
Triglycerides: Percent change at Week 106 (n= 1)	-57.98 (NA)
Triglycerides: Percent change at ET (n= 8)	-14.52 (25.892)
Triglycerides: Percent change at EOS (n= 3)	30.98 (40.511)
Apo A-1: Percent change at Week 30 (n= 7)	-27.20 (12.119)
Apo A-1: Percent change at Week 34 (n= 8)	-29.05 (17.483)
Apo A-1: Percent change at Week 38 (n= 8)	-11.79 (23.939)
Apo A-1: Percent change at Week 42 (n= 6)	-35.47 (9.512)
Apo A-1: Percent change at Week 44 (n= 8)	-34.28 (11.306)
Apo A-1: Percent change at Week 50 (n= 8)	-21.01 (15.471)
Apo A-1: Percent change at Week 70 (n= 4)	-25.28 (11.950)
Apo A-1: Percent change at Week 82 (n= 4)	-18.98 (6.534)
Apo A-1: Percent change at Week 94 (n= 1)	-22.45 (NA)
Apo A-1: Percent change at Week 106 (n= 1)	3.06 (NA)
Apo A-1: Percent change at ET (n= 8)	-9.63 (25.308)
Apo A-1: Percent change at EOS (n= 3)	11.27 (25.093)

20. Secondary Outcome

Title	Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Description	Absolute change was reported in HDL-C, TG and Apo A-1 from baseline (week 26) up to week 214. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)
Time Frame	Baseline (Week 26) up to Week 214

Outcome Measure Data

Analysis Population Description

"n" = Number of participants who were evaluable for this endpoint at a given time point.

Arm/Group Title	REGN1500 300 mg SC/20 mg/kg IV
Arm/Group Description	Participants received REGN1500 SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 [Day 1499]) after the last dose of study drug in the OLE treatment period.
Measure Participants	8
HDL-C: Change at Week 27 (n= 8)	-8.78 (5.736)
HDL-C: Change at Week 28 (n= 8)	-12.08 (7.244)
HDL-C: Change at Week 29 (n= 8)	-11.44 (7.858)
HDL-C: Change at Week 30 (n= 7)	-13.29 (9.270)
HDL-C: Change at Week 31 (n= 8)	-13.94 (8.655)
HDL-C: Change at Week 32 (n= 8)	-14.11 (8.163)
HDL-C: Change at Week 34 (n= 8)	-15.10 (9.167)
HDL-C: Change at Week 36 (n= 8)	-14.14 (10.426)
HDL-C: Change at Week 38 (n= 8)	-8.89 (7.513)
HDL-C: Change at Week 39 (n= 6)	-14.02 (8.023)
HDL-C: Change at Week 40 (n= 6)	-15.90 (7.171)
HDL-C: Change at Week 41 (n= 6)	-17.17 (8.262)
HDL-C: Change at Week 42 (n= 6)	-16.65 (7.148)
HDL-C: Change at Week 44 (n= 8)	-15.83 (8.167)
HDL-C: Change at Week 46 (n= 8)	-14.85 (10.173)
HDL-C: Change at Week 50 (n= 8)	-12.25 (10.985)
HDL-C: Change at Week 54 (n= 8)	-9.06 (9.107)
HDL-C: Change at Week 58 (n= 6)	-5.42 (6.058)
HDL-C: Change at Week 70 (n= 4)	-10.83 (10.448)
HDL-C: Change at Week 82 (n= 4)	-6.28 (2.655)
HDL-C: Change at Week 94 (n= 1)	-4.20 (NA)
HDL-C: Change at Week 106 (n= 1)	0.00 (NA)
HDL-C: Percent change at ET (n= 8)	-7.86 (8.258)
HDL-C: Change at EOS (n= 3)	-1.67 (10.698)
Triglycerides: Change at Week 27 (n= 8)	-31.19 (28.590)
Triglycerides: Change at Week 28 (n= 8)	-36.28 (30.630)
Triglycerides: Change at Week 29 (n= 8)	-32.86 (25.188)
Triglycerides: Change at Week 30 (n= 7)	-32.37 (30.475)
Triglycerides: Change at Week 31 (n= 8)	-39.04 (30.169)
Triglycerides: Change at Week 32 (n= 8)	-37.83 (30.808)
Triglycerides: Change at Week 34 (n= 8)	-25.41 (26.559)
Triglycerides: Change at Week 36 (n= 8)	-24.66 (28.139)
Triglycerides: Change at Week 38 (n= 8)	-21.13 (25.190)
Triglycerides: Change at Week 39 (n= 6)	-40.27 (32.803)
Triglycerides: Change at Week 40 (n= 6)	-37.30 (33.559)
Triglycerides: Change at Week 41 (n= 6)	-39.37 (33.251)
Triglycerides: Change at Week 42 (n= 6)	-37.62 (33.724)
Triglycerides: Change at Week 44 (n= 8)	-42.25 (32.682)
Triglycerides: Change at Week 46 (n= 8)	-31.53 (28.209)
Triglycerides: Change at Week 50 (n= 8)	-20.00 (27.720)
Triglycerides: Change at Week 54 (n= 8)	-6.40 (26.869)
Triglycerides: Change at Week 58 (n= 6)	-3.53 (21.753)
Triglycerides: Change at Week 70 (n= 4)	-21.23 (35.614)
Triglycerides: Change at Week 82 (n= 4)	-26.33 (21.457)
Triglycerides: Change at Week 94 (n= 1)	-88.50 (NA)
Triglycerides: Change at Week 106 (n= 1)	-67.20 (NA)
Triglycerides: Change at ET (n= 8)	-11.71 (21.343)
Triglycerides: Change at EOS (n= 3)	30.67 (35.390)
Apo A-1: Change at Week 30 (n= 7)	-34.4 (20.18)
Apo A-1: Change at Week 34 (n= 8)	-35.1 (24.70)
Apo A-1: Change at Week 38 (n= 8)	-18.0 (26.54)
Apo A-1: Change at Week 42 (n= 6)	-43.7 (15.71)
Apo A-1: Change at Week 44 (n= 8)	-39.4 (18.12)
Apo A-1: Change at Week 50 (n= 8)	-26.9 (23.56)
Apo A-1: Change at Week 70 (n= 4)	-30.3 (20.12)
Apo A-1: Change at Week 82 (n= 4)	-21.0 (5.83)
Apo A-1: Change at Week 94 (n= 1)	-22.0 (NA)
Apo A-1: Change at Week 106 (n= 1)	3.0 (NA)
Apo A-1: Change at ET (n= 8)	-15.6 (24.34)
Apo A-1: Change at EOS (n= 3)	7.0 (24.98)

21. Secondary Outcome

Title	Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Description	Absolute change was reported in Apo CIII from baseline (week 0) up to week 16. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time Frame	Baseline (Week 0) up to Week 16

Outcome Measure Data

Analysis Population Description

"n" = Number of participants who were evaluable for this endpoint at a given time point.

Arm/Group Title	REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Measure Participants	9
Apo CIII: Change at Day 4 (n = 9)	-3.729 (1.6905)
Apo CIII: Change at Week 1 (n = 9)	-4.296 (1.9829)
Apo CIII: Change at Week 2 (n = 9)	-4.301 (2.2542)
Apo CIII: Change at Week 5 (n = 8)	-6.000 (2.8541)
Apo CIII: Change at Week 6 (n = 1)	-8.380 (NA)
Apo CIII: Change at Week 12 (n = 9)	-3.772 (2.8443)
Apo CIII: Change at Week 14 (n = 9)	-3.866 (3.7327)
Apo CIII: Change at Week 16 (n = 9)	-2.757 (4.4877)

22. Secondary Outcome

Title	Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Description	Percent change was reported in Apo CIII from baseline (week 0) up to week 16. Apo CIII was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period.
Time Frame	Baseline (Week 0) to Week 16

Outcome Measure Data

Analysis Population Description

"n" = Number of participants who were evaluable for this endpoint at a given time point.

Arm/Group Title	REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Measure Participants	9
Apo CIII: Percent Change at Day 4 (n = 9)	-46.59 (22.129)
Apo CIII: Percent Change at Week 1 (n = 9)	-55.43 (18.541)
Apo CIII: Percent Change at Week 2 (n = 9)	-56.57 (24.815)
Apo CIII: Percent Change at Week 5 (n = 8)	-75.44 (9.667)
Apo CIII: Percent Change at Week 6 (n = 1)	-91.48 (NA)
Apo CIII: Percent Change at Week 12 (n = 9)	-49.07 (25.517)
Apo CIII: Percent Change at Week 14 (n = 9)	-40.67 (44.674)
Apo CIII: Percent Change at Week 16 (n = 9)	-28.30 (54.676)

Adverse Events

Time Frame	All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description	During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
Arm/Group Title	Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC		OLE Period: REGN1500 300 mg SC/20 mg/kg IV
Arm/Group Description	Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.		Participants received REGN1500 a SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 [Day 1499]) after the last dose of study drug in the OLE treatment period.
All Cause Mortality
	Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC		OLE Period: REGN1500 300 mg SC/20 mg/kg IV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/8 (0%)
Serious Adverse Events
	Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC		OLE Period: REGN1500 300 mg SC/20 mg/kg IV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/9 (11.1%)		2/8 (25%)
Cardiac disorders
Coronary artery disease	1/9 (11.1%)	1	0/8 (0%)	0
Coronary artery stenosis	0/9 (0%)	0	1/8 (12.5%)	1
Respiratory, thoracic and mediastinal disorders
Bronchospasm	0/9 (0%)	0	1/8 (12.5%)	1
Other (Not Including Serious) Adverse Events
	Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC		OLE Period: REGN1500 300 mg SC/20 mg/kg IV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/9 (100%)		8/8 (100%)
Blood and lymphatic system disorders
Anaemia	1/9 (11.1%)	1	1/8 (12.5%)	1
Eye disorders
Corneal opacity	1/9 (11.1%)	1	0/8 (0%)	0
Eye inflammation	0/9 (0%)	0	1/8 (12.5%)	1
Gastrointestinal disorders
Abdominal pain	0/9 (0%)	0	1/8 (12.5%)	2
Diarrhoea	1/9 (11.1%)	2	4/8 (50%)	6
Faeces discoloured	1/9 (11.1%)	1	0/8 (0%)	0
Nausea	4/9 (44.4%)	6	3/8 (37.5%)	5
Vomiting	1/9 (11.1%)	1	1/8 (12.5%)	1
General disorders
Chest discomfort	1/9 (11.1%)	1	1/8 (12.5%)	1
Chest pain	1/9 (11.1%)	1	0/8 (0%)	0
Fatigue	0/9 (0%)	0	1/8 (12.5%)	1
Injection site haematoma	0/9 (0%)	0	1/8 (12.5%)	1
Influenza like illness	2/9 (22.2%)	3	2/8 (25%)	2
Injection site haemorrhage	1/9 (11.1%)	2	0/8 (0%)	0
Local swelling	0/9 (0%)	0	1/8 (12.5%)	1
Oedema peripheral	0/9 (0%)	0	1/8 (12.5%)	1
Pyrexia	0/9 (0%)	0	1/8 (12.5%)	1
Immune system disorders
Food allergy	0/9 (0%)	0	1/8 (12.5%)	2
Infections and infestations
Gastroenteritis	1/9 (11.1%)	2	1/8 (12.5%)	1
Nasopharyngitis	2/9 (22.2%)	3	3/8 (37.5%)	4
Influenza	0/9 (0%)	0	1/8 (12.5%)	1
Pharyngitis	1/9 (11.1%)	1	0/8 (0%)	0
Rhinitis	0/9 (0%)	0	1/8 (12.5%)	1
Sinusitis	1/9 (11.1%)	2	2/8 (25%)	2
Upper respiratory tract infection	0/9 (0%)	0	2/8 (25%)	3
Urinary tract infection	0/9 (0%)	0	1/8 (12.5%)	1
Injury, poisoning and procedural complications
Crush injury	0/9 (0%)	0	1/8 (12.5%)	1
Contusion	0/9 (0%)	0	1/8 (12.5%)	1
Procedural hypotension	1/9 (11.1%)	1	0/8 (0%)	0
Thermal burn	1/9 (11.1%)	1	0/8 (0%)	0
Investigations
Blood creatine phosphokinase increased	1/9 (11.1%)	3	1/8 (12.5%)	2
Crystal urine present	1/9 (11.1%)	1	0/8 (0%)	0
Liver function test abnormal	1/9 (11.1%)	1	0/8 (0%)	0
Transaminases increased	0/9 (0%)	0	1/8 (12.5%)	1
Metabolism and nutrition disorders
Hypokalaemia	1/9 (11.1%)	1	0/8 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	4/9 (44.4%)	6	4/8 (50%)	8
Muscle spasms	1/9 (11.1%)	1	0/8 (0%)	0
Musculoskeletal pain	2/9 (22.2%)	2	2/8 (25%)	3
Myalgia	2/9 (22.2%)	2	0/8 (0%)	0
Neck pain	1/9 (11.1%)	1	1/8 (12.5%)	1
Pain in extremity	1/9 (11.1%)	1	1/8 (12.5%)	1
Nervous system disorders
Dizziness	1/9 (11.1%)	1	1/8 (12.5%)	1
Headache	1/9 (11.1%)	1	0/8 (0%)	0
Memory impairment	0/9 (0%)	0	1/8 (12.5%)	1
Psychiatric disorders
Insomnia	0/9 (0%)	0	1/8 (12.5%)	1
Renal and urinary disorders
Renal failure chronic	0/9 (0%)	0	1/8 (12.5%)	1
Respiratory, thoracic and mediastinal disorders
Bronchospasm	0/9 (0%)	0	1/8 (12.5%)	1
Cough	0/9 (0%)	0	1/8 (12.5%)	1
Dyspnoea	1/9 (11.1%)	1	0/8 (0%)	0
Epistaxis	1/9 (11.1%)	1	0/8 (0%)	0
Oropharyngeal pain	1/9 (11.1%)	1	0/8 (0%)	0
Rhinalgia	1/9 (11.1%)	1	0/8 (0%)	0
Upper-Airway cough syndrome	0/9 (0%)	0	1/8 (12.5%)	1
Skin and subcutaneous tissue disorders
Alopecia	0/9 (0%)	0	1/8 (12.5%)	1
Ecchymosis	1/9 (11.1%)	1	0/8 (0%)	0
Generalised erythema	0/9 (0%)	0	1/8 (12.5%)	1
Pruritus allergic	0/9 (0%)	0	1/8 (12.5%)	1
Rash	0/9 (0%)	0	1/8 (12.5%)	3
Vascular disorders
Flushing	1/9 (11.1%)	2	0/8 (0%)	0

Limitations/Caveats

At the time patients completed the main study, the open-label extension (OLE) study was not yet open to enrollment. Therefore, there was a lag of between 168 days to 586 days between the end of the main study and the start of the OLE study.

More Information

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.