Trial Outcomes & Findings for Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia (NCT NCT03399786)

Last Updated: 2021-05-18

Results Overview

Percent change was calculated as 100x(calculated LDL-C value at Week 24 - calculated LDL-C value at baseline)/calculated LDL-C value at baseline. The baseline LDL-C value was the last calculated LDL-C value obtained before the first dose of double-blind-study drug. The calculated LDL-C at week 24 was the LDL-C value obtained within the week 24 efficacy analysis window, regardless of adherence to treatment and subsequent therapies (intent-to-treat \[ITT\] estimand). The ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

65 participants

Primary outcome timeframe

Week 24

Results posted on

2021-05-18

Participant Flow

This study was conducted at 30 centers that enrolled participants in 11 countries in Europe, Asia, North America, and Australia. Randomization was stratified by apheresis treatment status and by region (Japan, Rest of the World \[ROW\]).

A total of 75 participants were screened and 65 participants randomized. There were 10 participants that were considered screen failures.

Participant milestones

Participant milestones
Measure	Placebo IV Q4W (DBTP) Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP).	Evinacumab 15 mg/kg (DBTP) Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP).	Placebo IV Q4W (OLTP) All participants in the placebo arm who completed the double-blind treatment period (DBTP) received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg (OLTP) All participants in the evinacumab arm who completed the double-blind treatment period (DBTP) received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Double-blind Treatment Period (DBTP) STARTED	22	43	0	0
Double-blind Treatment Period (DBTP) COMPLETED	21	43	0	0
Double-blind Treatment Period (DBTP) NOT COMPLETED	1	0	0	0
Open-label Treatment Period (OLTP) STARTED	0	0	20	44
Open-label Treatment Period (OLTP) COMPLETED	0	0	19	43
Open-label Treatment Period (OLTP) NOT COMPLETED	0	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo IV Q4W (DBTP) Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP).	Placebo IV Q4W (OLTP) All participants in the placebo arm who completed the double-blind treatment period (DBTP) received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg (OLTP) All participants in the evinacumab arm who completed the double-blind treatment period (DBTP) received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Double-blind Treatment Period (DBTP) Withdrawal by Subject	1	0	0
Open-label Treatment Period (OLTP) Noncompliance with protocol by the participant	0	1	0
Open-label Treatment Period (OLTP) Pregnancy	0	0	1

Baseline Characteristics

Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Total n=65 Participants Total of all reporting groups
Age, Continuous	36.7 Years STANDARD_DEVIATION 11.52 • n=39 Participants	44.3 Years STANDARD_DEVIATION 16.78 • n=41 Participants	41.7 Years STANDARD_DEVIATION 15.54 • n=35 Participants
Age, Customized ≥12 years to <18 years of age	1 Participants n=39 Participants	1 Participants n=41 Participants	2 Participants n=35 Participants
Age, Customized ≥18 years to <45 years of age	16 Participants n=39 Participants	23 Participants n=41 Participants	39 Participants n=35 Participants
Age, Customized ≥45 years to <65 years of age	5 Participants n=39 Participants	11 Participants n=41 Participants	16 Participants n=35 Participants
Age, Customized ≥65 years to <75 years of age	0 Participants n=39 Participants	7 Participants n=41 Participants	7 Participants n=35 Participants
Age, Customized ≥75 years of age	0 Participants n=39 Participants	1 Participants n=41 Participants	1 Participants n=35 Participants
Sex: Female, Male Female	11 Participants n=39 Participants	24 Participants n=41 Participants	35 Participants n=35 Participants
Sex: Female, Male Male	11 Participants n=39 Participants	19 Participants n=41 Participants	30 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=39 Participants	1 Participants n=41 Participants	2 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=39 Participants	38 Participants n=41 Participants	58 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants	4 Participants n=41 Participants	5 Participants n=35 Participants
Race White	17 Participants n=39 Participants	31 Participants n=41 Participants	48 Participants n=35 Participants
Race Black or African American	0 Participants n=39 Participants	2 Participants n=41 Participants	2 Participants n=35 Participants
Race Asian	4 Participants n=39 Participants	6 Participants n=41 Participants	10 Participants n=35 Participants
Race American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race Not Reported	0 Participants n=39 Participants	2 Participants n=41 Participants	2 Participants n=35 Participants
Race Other	1 Participants n=39 Participants	2 Participants n=41 Participants	3 Participants n=35 Participants
Calculated Low-density Lipoprotein Cholesterol (LDL-C)	246.5 Milligrams per Deciliter (mg/dL) STANDARD_DEVIATION 153.71 • n=39 Participants	259.5 Milligrams per Deciliter (mg/dL) STANDARD_DEVIATION 172.40 • n=41 Participants	255.1 Milligrams per Deciliter (mg/dL) STANDARD_DEVIATION 165.21 • n=35 Participants
Apolipoprotein B (Apo B)	175.9 mg/dL STANDARD_DEVIATION 98.76 • n=39 Participants	169.1 mg/dL STANDARD_DEVIATION 82.75 • n=41 Participants	171.4 mg/dL STANDARD_DEVIATION 87.78 • n=35 Participants
Non-high-density Lipoprotein Cholesterol (non-HDL-C)	269.9 mg/dL STANDARD_DEVIATION 157.81 • n=39 Participants	281.9 mg/dL STANDARD_DEVIATION 172.61 • n=41 Participants	277.8 mg/dL STANDARD_DEVIATION 166.60 • n=35 Participants
Total Cholesterol (TC)	315.9 mg/dL STANDARD_DEVIATION 150.44 • n=39 Participants	325.6 mg/dL STANDARD_DEVIATION 170.76 • n=41 Participants	322.3 mg/dL STANDARD_DEVIATION 163.05 • n=35 Participants
Lipoprotein A (Lp[a])	103.4 Nanomoles per Liter (nmol/L) STANDARD_DEVIATION 109.43 • n=39 Participants	111.3 Nanomoles per Liter (nmol/L) STANDARD_DEVIATION 114.40 • n=41 Participants	108.7 Nanomoles per Liter (nmol/L) STANDARD_DEVIATION 111.95 • n=35 Participants
Fasting Triglycerides (TG)	144.1 mg/dL STANDARD_DEVIATION 144.54 • n=39 Participants	113.1 mg/dL STANDARD_DEVIATION 68.39 • n=41 Participants	123.6 mg/dL STANDARD_DEVIATION 100.71 • n=35 Participants
Apolipoprotein CIII (Apo CIII)	9.7 mg/dL STANDARD_DEVIATION 5.23 • n=39 Participants	9.2 mg/dL STANDARD_DEVIATION 4.00 • n=41 Participants	9.39 mg/dL STANDARD_DEVIATION 4.42 • n=35 Participants

PRIMARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Percent Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24 (Intent-to-Treat [ITT] Estimand)	1.9 Percent Change Standard Error 6.5 • Interval 6.5 to	-47.1 Percent Change Standard Error 4.6 • Interval 4.6 to

SECONDARY outcome

Timeframe: Week 24

Percent change in Apo B from baseline at Week 24 in the DBTP was reported; value obtained regardless of adherence to study treatment and subsequent therapies (ITT estimand). ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 24 (ITT Estimand)	-4.5 Percent Change Standard Error 4.8 • Interval 4.8 to	-41.4 Percent Change Standard Error 3.3 • Interval 3.3 to

SECONDARY outcome

Timeframe: Week 24

Percent change from baseline in non-HDL-C at Week 24 in the DBTP was reported; value obtained regardless of adherence to study treatment and subsequent therapies (ITT estimand). ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 24 (ITT Estimand)	2.0 Percent Change Standard Error 5.4 • Interval 5.4 to	-49.7 Percent Change Standard Error 3.8 • Interval 3.8 to

SECONDARY outcome

Timeframe: Week 24

Percent change in TC from baseline at Week 24 in the DBTP was reported; value obtained regardless of adherence to study treatment and subsequent therapies (ITT estimand). ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Percent Change in Total Cholesterol (TC) From Baseline to Week 24 (ITT Estimand)	1.0 Percent Change Standard Error 4.2 • Interval 4.2 to	-47.4 Percent Change Standard Error 3.0 • Interval 3.0 to

SECONDARY outcome

Timeframe: At Week 24

Percentage of participants who achieved reduction in calculated LDL-C ≥30% at Week 24 in the DBTP was reported; value obtained regardless of adherence to study treatment and subsequent therapies (ITT estimand). ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Percentage of Participants With ≥30% Reduction in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 (ITT Estimand)	18.2 Percentage of Participants	83.7 Percentage of Participants

SECONDARY outcome

Timeframe: At Week 24

Percentage of participants who achieved reduction in calculated LDL-C ≥ 50% at Week 24 in the DBTP was reported; value obtained regardless of adherence to study treatment and subsequent therapies (ITT estimand). ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Percentage of Participants With ≥50% Reduction in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 (ITT Estimand)	4.5 Percentage of Participants	55.8 Percentage of Participants

SECONDARY outcome

Timeframe: Week 24

Absolute change in calculated LDL-C from baseline at Week 24 in the DBTP was reported; value obtained regardless of adherence to study treatment and subsequent therapies (ITT estimand). ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Absolute Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24 (ITT Estimand)	-2.6 Milligrams per Deciliter (mg/dL) Standard Error 17.6 • Interval 17.6 to	-134.7 Milligrams per Deciliter (mg/dL) Standard Error 12.4 • Interval 12.4 to

SECONDARY outcome

Timeframe: At Week 24

US apheresis eligibility criteria included participants who had inadequate response to diet and LMTs after 6 months of treatment and with functional Homozygous familial hypercholesterolemia (HoFH) or Heterozygous familial hypercholesterolemia (HeFH) (with 0-1 risk factor) with LDL-C ≥ 300 mg/dL (7.77 mmol/L). Percentage of participants who met US apheresis eligibility criteria at Week 24 in the DBTP was reported; value obtained regardless of adherence to study treatment and subsequent therapies (ITT estimand). ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Percentage of Participants Who Met United States (US) Apheresis Eligibility Criteria at Week 24 (ITT Estimand)	22.7 Percentage of Participants	7.0 Percentage of Participants

SECONDARY outcome

Timeframe: At Week 24

Percentage of participants with LDL-C value \<100 mg/dL (2.59 mmol/L) in the DBTP at Week 24 was reported; value obtained regardless of adherence to study treatment and subsequent therapies (ITT estimand). ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analysed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Percentage of Participants With Low-Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter (mg/dL) (2.59 Millimoles Per Liter [mmol/L]) at Week 24 (ITT Estimand)	22.7 Percentage of Participants	46.5 Percentage of Participants

SECONDARY outcome

Timeframe: At Week 24

EU apheresis eligibility criteria included participants who had inadequate response to diet and Lipid modifying therapies (LMTs) after 3 months of treatment, Primary prevention: Participants with Familial hypercholesterolemia (FH) with LDL-C \>160 mg/dL (4.2 mmol/L) and Cardiovascular (CV) events in close relatives. Secondary prevention: Participants with progressive CV events with LDL-C \> 120 to 130 mg/dL (3.1-3.4 mmol/L). Percentage of participants who met EU apheresis eligibility criteria at Week 24 in the DBTP was reported; value obtained regardless of adherence to study treatment and subsequent therapies (ITT estimand). ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Percentage of Participants Who Met European Union (EU) Apheresis Eligibility Criteria at Week 24 (ITT Estimand)	77.3 Percentage of Participants	32.6 Percentage of Participants

SECONDARY outcome

Timeframe: At Week 24

Percentage of participants with LDL-C \<70 mg/dL (1.81 mmol/L) at Week 24 in the DBTP was reported; value obtained regardless of adherence to study treatment and subsequent therapies (ITT estimand). ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Percentage of Participants With Calculated Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL (1.81 mmol/L) at Week 24 (ITT Estimand)	4.5 Percentage of Participants	27.9 Percentage of Participants

SECONDARY outcome

Timeframe: Week 24

Percent change from baseline in TG at Week 24 in the DBTP was reported; value obtained regardless of adherence to study treatment and subsequent therapies (ITT estimand). ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Percent Change in Fasting Triglycerides (TG) From Baseline to Week 24 (ITT Estimand)	-4.6 Percent Change Standard Error 7.0 • Interval 7.0 to	-55.0 Percent Change Standard Error 3.1 • Interval 3.1 to

SECONDARY outcome

Timeframe: Week 24

Percent change in Lp(a) from baseline at Week 24 in the DBTP was reported; value obtained regardless of adherence to study treatment and subsequent therapies (ITT estimand). ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Percent Change in Lipoprotein A (Lp[a]) From Baseline to Week 24 (ITT Estimand)	-3.6 Percent Change Standard Error 5.8 • Interval 5.8 to	-5.5 Percent Change Standard Error 4.0 • Interval 4.0 to

SECONDARY outcome

Timeframe: Week 24

Absolute change in Apo B from baseline at Week 24 in the DBTP was reported; value obtained regardless of adherence to study treatment and subsequent therapies (ITT estimand). ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Absolute Change in Apolipoprotein B (Apo B) From Baseline to Week 24 (ITT Estimand)	-8.0 mg/dL Standard Error 9.1 • Interval 9.1 to	-74.4 mg/dL Standard Error 6.3 • Interval 6.3 to

SECONDARY outcome

Timeframe: Week 24

Absolute change in non-HDL-C from baseline at Week 24 in the DBTP was reported; value obtained regardless of adherence to study treatment and subsequent therapies (ITT estimand). ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Absolute Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 24 (ITT Estimand)	-0.4 mg/dL Standard Error 17.4 • Interval 17.4 to	-148.0 mg/dL Standard Error 12.3 • Interval 12.3 to

SECONDARY outcome

Timeframe: Week 24

Absolute change in TC from baseline at Week 24 in the DBTP was reported; value obtained regardless of adherence to study treatment and subsequent therapies (ITT estimand). ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Absolute Change in Total Cholesterol (TC) From Baseline to Week 24 (ITT Estimand)	-0.4 mg/dL Standard Error 17.2 • Interval 17.2 to	-161.6 mg/dL Standard Error 12.2 • Interval 12.2 to

SECONDARY outcome

Timeframe: Week 24

Percent change in Apo CIII from baseline at Week 24 in the DBTP was reported; value obtained regardless of adherence to study treatment and subsequent therapies (ITT estimand). ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).

Outcome measures

Outcome measures
Measure	Placebo IV Q4W n=22 Participants Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg IV Q4W n=43 Participants Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP). All participants who completed the double-blind treatment period received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline to Week 24 (ITT Estimand)	5.8 Percent Change Standard Error 5.5 • Interval 5.5 to	-84.1 Percent Change Standard Error 3.9 • Interval 3.9 to

Adverse Events

Placebo IV Q4W (DBTP)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Evinacumab 15 mg/kg (DBTP)

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo IV Q4W (OLTP)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Evinacumab 15 mg/kg (OLTP)

Serious events: 7 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo IV Q4W (DBTP) n=21 participants at risk Participants received IV infusion of placebo matched to evinacumab every 4 weeks (Q4W) from day 1 to week 20 in the double-blind treatment period (DBTP).	Evinacumab 15 mg/kg (DBTP) n=44 participants at risk Participants received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from day 1 to week 20 in the double-blind treatment period (DBTP).	Placebo IV Q4W (OLTP) n=20 participants at risk All participants in the placebo arm who completed the double-blind treatment period (DBTP) received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).	Evinacumab 15 mg/kg (OLTP) n=44 participants at risk All participants in the evinacumab arm who completed the double-blind treatment period (DBTP) received IV infusion of evinacumab at a dose of 15 mg/kg Q4W from week 24 to week 44 in the open-label treatment period (OLTP).
Cardiac disorders Acute myocardial infarction	0.00% 0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/44 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	2.3% 1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm
Cardiac disorders Angina pectoris	0.00% 0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/44 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	2.3% 1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm
Cardiac disorders Angina unstable	0.00% 0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/44 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	2.3% 1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm
Cardiac disorders Cardiac failure congestive	0.00% 0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/44 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	2.3% 1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm
Cardiac disorders Coronary artery disease	0.00% 0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/44 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	2.3% 1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm
Eye disorders Glaucoma	0.00% 0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/44 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	2.3% 1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm
Infections and infestations Pyelonephritis	0.00% 0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/44 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	2.3% 1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm
Infections and infestations Urosepsis	0.00% 0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	2.3% 1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/44 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm
Injury, poisoning and procedural complications Cardiac procedure complication	0.00% 0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/44 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	2.3% 1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm
Injury, poisoning and procedural complications Carotid artery restenosis	0.00% 0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/44 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	2.3% 1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm
Psychiatric disorders Suicide attempt	0.00% 0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	2.3% 1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/44 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm
Renal and urinary disorders Nephrocalcinosis	0.00% 0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/44 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	2.3% 1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm
Vascular disorders Aortic stenosis	0.00% 0/21 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/44 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	0.00% 0/20 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm	2.3% 1/44 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up until end of study (Week 68) regardless of seriousness or relationship to investigational product (IP). For purpose of safety analysis, arm assignments for participants in Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo arm who inadvertently received evinacumab 15mg/kg was included in Evinacumab 15mg/kg arm

Other adverse events

Additional Information

Clinical Trials Administrator

Regeneron Pharmaceuticals, Inc.

Phone: 844-734-6643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER