Trial Outcomes & Findings for Study of ARO-ANG3 in Participants With Homozygous Familial Hypercholesterolemia (HOFH) (NCT NCT05217667)
NCT ID: NCT05217667
Last Updated: 2026-06-12
Results Overview
LDL-C, computed using Friedewald formula, Martin-Hopkins methodology and preparative ultracentrifugation (PUC).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2026-06-12
Participant Flow
In this open-label clinical study, participants were randomized in a 1:1 ratio into ARO-ANG3 200 mg or 300 mg dose groups.
Participant milestones
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension (EXT) period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
36-Week Treatment Period
STARTED
|
9
|
9
|
|
36-Week Treatment Period
COMPLETED
|
9
|
9
|
|
36-Week Treatment Period
NOT COMPLETED
|
0
|
0
|
|
24-Month Extension Treatment Period
STARTED
|
9
|
9
|
|
24-Month Extension Treatment Period
COMPLETED
|
0
|
0
|
|
24-Month Extension Treatment Period
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension (EXT) period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
24-Month Extension Treatment Period
Study terminated by sponsor
|
7
|
8
|
|
24-Month Extension Treatment Period
Withdrawal by Subject
|
1
|
1
|
|
24-Month Extension Treatment Period
Pregnancy
|
1
|
0
|
Baseline Characteristics
Study of ARO-ANG3 in Participants With Homozygous Familial Hypercholesterolemia (HOFH)
Baseline characteristics by cohort
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.6 years
STANDARD_DEVIATION 19.46 • n=9 Participants
|
36.4 years
STANDARD_DEVIATION 18.09 • n=27 Participants
|
43.0 years
STANDARD_DEVIATION 19.44 • n=267 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
13 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Low Density Lipoprotein Cholesterol (LDL-C)
LDL-C, Friedewald Formula
|
342.7 (mg/dL
STANDARD_DEVIATION 238.07 • n=9 Participants
|
428.7 (mg/dL
STANDARD_DEVIATION 220.43 • n=27 Participants
|
385.7 (mg/dL
STANDARD_DEVIATION 226.93 • n=267 Participants
|
|
Low Density Lipoprotein Cholesterol (LDL-C)
LDL-C, PUC
|
335.0 (mg/dL
STANDARD_DEVIATION 225.55 • n=9 Participants
|
420.6 (mg/dL
STANDARD_DEVIATION 215.72 • n=27 Participants
|
377.8 (mg/dL
STANDARD_DEVIATION 218.58 • n=267 Participants
|
|
Low Density Lipoprotein Cholesterol (LDL-C)
LDL-C, Martin-Hopkins Methodology
|
343.3 (mg/dL
STANDARD_DEVIATION 240.71 • n=9 Participants
|
426.8 (mg/dL
STANDARD_DEVIATION 219.92 • n=27 Participants
|
385.1 (mg/dL
STANDARD_DEVIATION 227.75 • n=267 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Full Analysis Set: All randomized participants who receive at least 1 dose of investigational product (IP)
LDL-C, computed using Friedewald formula, Martin-Hopkins methodology and preparative ultracentrifugation (PUC).
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Percent Change From Baseline in Fasting LDL-C at Week 24
LDL-C Friedewald Formula
|
-36.79 percentage change
Standard Deviation 28.916
|
-40.10 percentage change
Standard Deviation 18.335
|
|
Percent Change From Baseline in Fasting LDL-C at Week 24
LDL-C PUC
|
-35.68 percentage change
Standard Deviation 28.554
|
-39.94 percentage change
Standard Deviation 18.122
|
|
Percent Change From Baseline in Fasting LDL-C at Week 24
LDL-C Martin-Hopkins Methodology
|
-38.34 percentage change
Standard Deviation 28.870
|
-40.88 percentage change
Standard Deviation 18.612
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 28
|
-40.70 percentage change
Standard Deviation 16.466
|
-34.81 percentage change
Standard Deviation 26.207
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 32
|
-28.85 percentage change
Standard Deviation 18.412
|
-33.12 percentage change
Standard Deviation 25.463
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 36/Extension Period Day 1
|
-21.11 percentage change
Standard Deviation 16.129
|
-28.92 percentage change
Standard Deviation 21.960
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 1
|
-36.18 percentage change
Standard Deviation 21.684
|
-47.03 percentage change
Standard Deviation 18.796
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 2
|
-39.46 percentage change
Standard Deviation 18.977
|
-42.12 percentage change
Standard Deviation 21.057
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 3
|
-31.26 percentage change
Standard Deviation 14.697
|
-43.69 percentage change
Standard Deviation 17.100
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 6
|
-33.30 percentage change
Standard Deviation 22.544
|
-39.66 percentage change
Standard Deviation 16.873
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 9
|
-43.92 percentage change
Standard Deviation 17.922
|
-39.04 percentage change
Standard Deviation 21.766
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 12
|
-38.25 percentage change
Standard Deviation 29.764
|
-43.07 percentage change
Standard Deviation 12.729
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 15
|
-41.73 percentage change
Standard Deviation 26.192
|
-41.58 percentage change
Standard Deviation 19.438
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 18
|
-36.72 percentage change
Standard Deviation 8.376
|
-48.03 percentage change
Standard Deviation 9.023
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 21
|
-38.40 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-53.15 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 4
|
-27.83 percentage change
Standard Deviation 25.882
|
-19.69 percentage change
Standard Deviation 19.265
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 8
|
-27.27 percentage change
Standard Deviation 20.516
|
-30.07 percentage change
Standard Deviation 20.929
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 12
|
-23.38 percentage change
Standard Deviation 19.398
|
-33.20 percentage change
Standard Deviation 20.853
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 16
|
-35.65 percentage change
Standard Deviation 18.342
|
-40.22 percentage change
Standard Deviation 20.010
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 20
|
-44.99 percentage change
Standard Deviation 13.282
|
-43.21 percentage change
Standard Deviation 16.710
|
|
Percent Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 24
|
-35.68 percentage change
Standard Deviation 28.554
|
-39.94 percentage change
Standard Deviation 18.122
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 4
|
-68.1 mg/dL
Standard Deviation 54.60
|
-84.6 mg/dL
Standard Deviation 85.88
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 8
|
-93.6 mg/dL
Standard Deviation 74.37
|
-109.8 mg/dL
Standard Deviation 88.77
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 12
|
-88.2 mg/dL
Standard Deviation 102.02
|
-150.3 mg/dL
Standard Deviation 139.66
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 16
|
-111.3 mg/dL
Standard Deviation 77.18
|
-159.4 mg/dL
Standard Deviation 132.50
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 20
|
-155.3 mg/dL
Standard Deviation 101.61
|
-187.9 mg/dL
Standard Deviation 131.88
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 24
|
-123.0 mg/dL
Standard Deviation 137.29
|
-166.0 mg/dL
Standard Deviation 136.71
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 28
|
-150.4 mg/dL
Standard Deviation 124.51
|
-132.8 mg/dL
Standard Deviation 141.12
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 32
|
-107.9 mg/dL
Standard Deviation 113.66
|
-121.4 mg/dL
Standard Deviation 128.45
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Week 36/Extension Period Day 1
|
-75.7 mg/dL
Standard Deviation 92.61
|
-108.3 mg/dL
Standard Deviation 108.18
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 1
|
-118.3 mg/dL
Standard Deviation 94.29
|
-186.8 mg/dL
Standard Deviation 144.73
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 2
|
-127.1 mg/dL
Standard Deviation 95.17
|
-181.1 mg/dL
Standard Deviation 136.82
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 3
|
-102.0 mg/dL
Standard Deviation 98.71
|
-176.4 mg/dL
Standard Deviation 117.12
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 6
|
-113.0 mg/dL
Standard Deviation 122.69
|
-172.3 mg/dL
Standard Deviation 139.58
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 9
|
-154.7 mg/dL
Standard Deviation 120.08
|
-172.5 mg/dL
Standard Deviation 160.59
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 12
|
-141.3 mg/dL
Standard Deviation 171.42
|
-179.1 mg/dL
Standard Deviation 133.98
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 15
|
-112.0 mg/dL
Standard Deviation 92.71
|
-183.4 mg/dL
Standard Deviation 176.95
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 18
|
-84.3 mg/dL
Standard Deviation 66.37
|
-103.0 mg/dL
Standard Deviation 47.15
|
|
Absolute Change From Baseline in Fasting LDL-C (PUC) Over Time
Change at Extension Month 21
|
-38.40 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-53.15 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 16
|
-36.71 percentage change
Standard Deviation 18.664
|
-41.56 percentage change
Standard Deviation 20.491
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 20
|
-46.93 percentage change
Standard Deviation 13.533
|
-43.16 percentage change
Standard Deviation 17.067
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 24
|
-36.79 percentage change
Standard Deviation 28.916
|
-40.10 percentage change
Standard Deviation 18.335
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 28
|
-41.53 percentage change
Standard Deviation 16.158
|
-35.16 percentage change
Standard Deviation 26.449
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 32
|
-29.95 percentage change
Standard Deviation 20.771
|
-33.78 percentage change
Standard Deviation 25.124
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 36/Extension Period Day 1
|
-22.77 percentage change
Standard Deviation 16.547
|
-30.03 percentage change
Standard Deviation 21.839
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 1
|
-36.81 percentage change
Standard Deviation 22.522
|
-41.24 percentage change
Standard Deviation 25.312
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 2
|
-40.50 percentage change
Standard Deviation 19.977
|
-42.21 percentage change
Standard Deviation 21.269
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 3
|
-31.31 percentage change
Standard Deviation 14.853
|
-42.45 percentage change
Standard Deviation 18.503
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 6
|
-32.98 percentage change
Standard Deviation 22.755
|
-40.87 percentage change
Standard Deviation 16.723
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 9
|
-44.08 percentage change
Standard Deviation 18.408
|
-40.97 percentage change
Standard Deviation 18.645
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 12
|
-31.11 percentage change
Standard Deviation 35.128
|
-43.77 percentage change
Standard Deviation 13.293
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 15
|
-45.45 percentage change
Standard Deviation 27.212
|
-42.22 percentage change
Standard Deviation 20.860
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 18
|
-39.47 percentage change
Standard Deviation 7.571
|
-50.40 percentage change
Standard Deviation 8.223
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 21
|
-43.49 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-54.07 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 8
|
-28.27 percentage change
Standard Deviation 21.716
|
-30.76 percentage change
Standard Deviation 20.567
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 12
|
-23.50 percentage change
Standard Deviation 20.560
|
-32.31 percentage change
Standard Deviation 19.843
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 4
|
-27.43 percentage change
Standard Deviation 27.042
|
-21.38 percentage change
Standard Deviation 19.071
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 4
|
-64.4 mg/dL
Standard Deviation 69.81
|
-92.3 mg/dL
Standard Deviation 90.82
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 8
|
-100.2 mg/dL
Standard Deviation 82.08
|
-112.4 mg/dL
Standard Deviation 91.97
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 12
|
-94.9 mg/dL
Standard Deviation 114.91
|
-150.3 mg/dL
Standard Deviation 141.86
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 16
|
-119.0 mg/dL
Standard Deviation 87.02
|
-170.1 mg/dL
Standard Deviation 140.21
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 20
|
-166.0 mg/dL
Standard Deviation 109.08
|
-189.7 mg/dL
Standard Deviation 139.09
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 24
|
-133.1 mg/dL
Standard Deviation 146.24
|
-168.4 mg/dL
Standard Deviation 141.80
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 28
|
-156.0 mg/dL
Standard Deviation 129.17
|
-134.3 mg/dL
Standard Deviation 148.09
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 32
|
-115.8 mg/dL
Standard Deviation 121.44
|
-126.4 mg/dL
Standard Deviation 133.84
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Week 36/Extension Period Day 1
|
-86.8 mg/dL
Standard Deviation 102.70
|
-113.3 mg/dL
Standard Deviation 111.93
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 1
|
-126.2 mg/dL
Standard Deviation 104.74
|
-164.6 mg/dL
Standard Deviation 157.19
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 2
|
-134.6 mg/dL
Standard Deviation 105.09
|
-184.6 mg/dL
Standard Deviation 144.20
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 3
|
-106.4 mg/dL
Standard Deviation 107.77
|
-170.9 mg/dL
Standard Deviation 121.83
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 6
|
-116.1 mg/dL
Standard Deviation 135.18
|
-176.6 mg/dL
Standard Deviation 139.76
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 9
|
-159.4 mg/dL
Standard Deviation 128.86
|
-188.6 mg/dL
Standard Deviation 156.62
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 12
|
-116.1 mg/dL
Standard Deviation 198.15
|
-183.9 mg/dL
Standard Deviation 140.06
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 15
|
-122.5 mg/dL
Standard Deviation 98.25
|
-187.1 mg/dL
Standard Deviation 186.99
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 18
|
-96.3 mg/dL
Standard Deviation 79.61
|
-109.0 mg/dL
Standard Deviation 53.70
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Friedewald Formula) Over Time
Change at Extension Month 21
|
-167.0 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-73.0 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 4
|
-28.53 percentage change
Standard Deviation 27.207
|
-21.99 percentage change
Standard Deviation 19.078
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 8
|
-29.27 percentage change
Standard Deviation 21.231
|
-31.55 percentage change
Standard Deviation 20.546
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 12
|
-24.99 percentage change
Standard Deviation 20.149
|
-32.98 percentage change
Standard Deviation 19.828
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 16
|
-37.97 percentage change
Standard Deviation 18.782
|
-42.17 percentage change
Standard Deviation 20.955
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 20
|
-48.08 percentage change
Standard Deviation 13.287
|
-43.96 percentage change
Standard Deviation 17.260
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 24
|
-38.34 percentage change
Standard Deviation 28.870
|
-40.88 percentage change
Standard Deviation 18.612
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 28
|
-42.57 percentage change
Standard Deviation 16.186
|
-35.84 percentage change
Standard Deviation 26.722
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 32
|
-31.38 percentage change
Standard Deviation 19.993
|
-34.44 percentage change
Standard Deviation 25.219
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 36/Extension Period Day 1
|
-24.15 percentage change
Standard Deviation 15.905
|
-30.69 percentage change
Standard Deviation 22.170
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 1
|
-38.21 percentage change
Standard Deviation 22.258
|
-42.08 percentage change
Standard Deviation 25.450
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 2
|
-41.65 percentage change
Standard Deviation 19.597
|
-43.01 percentage change
Standard Deviation 21.307
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 3
|
-32.78 percentage change
Standard Deviation 14.772
|
-43.21 percentage change
Standard Deviation 18.620
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 6
|
-34.30 percentage change
Standard Deviation 22.650
|
-41.67 percentage change
Standard Deviation 16.818
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 9
|
-45.27 percentage change
Standard Deviation 17.765
|
-41.83 percentage change
Standard Deviation 18.783
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 12
|
-32.45 percentage change
Standard Deviation 35.027
|
-44.43 percentage change
Standard Deviation 13.318
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 15
|
-46.61 percentage change
Standard Deviation 26.813
|
-43.10 percentage change
Standard Deviation 21.140
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 18
|
-40.25 percentage change
Standard Deviation 8.468
|
-51.08 percentage change
Standard Deviation 9.126
|
|
Percent Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 21
|
-45.38 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-55.64 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 4
|
-67.2 mg/dL
Standard Deviation 68.68
|
-94.1 mg/dL
Standard Deviation 90.01
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 8
|
-103.2 mg/dL
Standard Deviation 83.76
|
-114.4 mg/dL
Standard Deviation 91.79
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 12
|
-98.7 mg/dL
Standard Deviation 118.30
|
-152.2 mg/dL
Standard Deviation 141.63
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 16
|
-122.6 mg/dL
Standard Deviation 90.70
|
-171.5 mg/dL
Standard Deviation 140.29
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 20
|
-169.6 mg/dL
Standard Deviation 112.71
|
-191.2 mg/dL
Standard Deviation 138.28
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 24
|
-137.4 mg/dL
Standard Deviation 150.41
|
-170.2 mg/dL
Standard Deviation 141.44
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 28
|
-159.4 mg/dL
Standard Deviation 132.26
|
-135.8 mg/dL
Standard Deviation 147.78
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 32
|
-119.4 mg/dL
Standard Deviation 124.79
|
-128.1 mg/dL
Standard Deviation 133.38
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Week 36/Extension Period Day 1
|
-90.4 mg/dL
Standard Deviation 106.96
|
-114.8 mg/dL
Standard Deviation 111.89
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 1
|
-130.2 mg/dL
Standard Deviation 108.61
|
-166.3 mg/dL
Standard Deviation 156.08
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 2
|
-137.9 mg/dL
Standard Deviation 109.00
|
-187.0 mg/dL
Standard Deviation 143.32
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 3
|
-110.1 mg/dL
Standard Deviation 111.46
|
-172.4 mg/dL
Standard Deviation 121.24
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 6
|
-119.7 mg/dL
Standard Deviation 139.04
|
-178.5 mg/dL
Standard Deviation 139.35
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 9
|
-162.9 mg/dL
Standard Deviation 132.54
|
-190.8 mg/dL
Standard Deviation 156.46
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 12
|
-120.0 mg/dL
Standard Deviation 202.32
|
-185.8 mg/dL
Standard Deviation 140.10
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 15
|
-124.2 mg/dL
Standard Deviation 98.40
|
-189.1 mg/dL
Standard Deviation 186.06
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 18
|
-99.7 mg/dL
Standard Deviation 84.95
|
-109.0 mg/dL
Standard Deviation 54.62
|
|
Absolute Change From Baseline in Fasting Calculated LDL-C (Martin-Hopkins Methodology) Over Time
Change at Extension Month 21
|
-177.0 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-74.0 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Week 4
|
-75.99 percentage change
Standard Deviation 13.717
|
-77.66 percentage change
Standard Deviation 11.918
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Week 8
|
-72.23 percentage change
Standard Deviation 18.516
|
-77.33 percentage change
Standard Deviation 10.273
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Week 12
|
-69.66 percentage change
Standard Deviation 17.001
|
-66.64 percentage change
Standard Deviation 19.578
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Week 16
|
-83.91 percentage change
Standard Deviation 8.836
|
-80.91 percentage change
Standard Deviation 15.104
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Week 20
|
-83.25 percentage change
Standard Deviation 7.953
|
-79.51 percentage change
Standard Deviation 14.695
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Week 24
|
-81.00 percentage change
Standard Deviation 11.014
|
-74.82 percentage change
Standard Deviation 20.002
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Week 28
|
-76.19 percentage change
Standard Deviation 9.785
|
-70.35 percentage change
Standard Deviation 25.427
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Week 32
|
-69.42 percentage change
Standard Deviation 14.106
|
-59.70 percentage change
Standard Deviation 34.572
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Week 36/Extension Period Day 1
|
-66.57 percentage change
Standard Deviation 13.478
|
-59.54 percentage change
Standard Deviation 33.818
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Extension Month 1
|
-82.59 percentage change
Standard Deviation 8.319
|
-77.52 percentage change
Standard Deviation 15.543
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Extension Month 2
|
-80.72 percentage change
Standard Deviation 14.062
|
-75.46 percentage change
Standard Deviation 14.189
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Extension Month 3
|
-78.18 percentage change
Standard Deviation 11.013
|
-76.65 percentage change
Standard Deviation 15.024
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Extension Month 6
|
-81.22 percentage change
Standard Deviation 8.489
|
-80.14 percentage change
Standard Deviation 13.502
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Extension Month 9
|
-84.37 percentage change
Standard Deviation 8.689
|
-75.21 percentage change
Standard Deviation 20.166
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Extension Month 12
|
-83.81 percentage change
Standard Deviation 10.646
|
-85.60 percentage change
Standard Deviation 9.790
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Extension Month 15
|
-87.29 percentage change
Standard Deviation 6.102
|
-86.95 percentage change
Standard Deviation 11.749
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Extension Month 18
|
-69.93 percentage change
Standard Deviation 11.949
|
-90.62 percentage change
Standard Deviation 9.120
|
|
Percent Change From Baseline in Fasting Angiopoietin-like 3 (ANGPTL3) Over Time
Change at Extension Month 21
|
-82.96 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-96.17 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Extension Month 6
|
-58.73 mg/dL
Standard Deviation 26.754
|
-87.81 mg/dL
Standard Deviation 68.827
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Extension Month 9
|
-61.83 mg/dL
Standard Deviation 27.948
|
-81.77 mg/dL
Standard Deviation 68.936
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Extension Month 12
|
-61.97 mg/dL
Standard Deviation 29.892
|
-93.64 mg/dL
Standard Deviation 65.406
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Extension Month 15
|
-71.12 mg/dL
Standard Deviation 27.000
|
-94.50 mg/dL
Standard Deviation 65.580
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Extension Month 18
|
-63.10 mg/dL
Standard Deviation 40.721
|
-131.17 mg/dL
Standard Deviation 101.595
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Extension Month 21
|
-112.50 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-98.00 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Week 4
|
-55.94 mg/dL
Standard Deviation 27.798
|
-75.86 mg/dL
Standard Deviation 44.132
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Week 8
|
-53.27 mg/dL
Standard Deviation 29.318
|
-74.35 mg/dL
Standard Deviation 53.111
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Week 12
|
-51.62 mg/dL
Standard Deviation 28.183
|
-71.36 mg/dL
Standard Deviation 60.240
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Week 16
|
-60.86 mg/dL
Standard Deviation 28.032
|
-86.10 mg/dL
Standard Deviation 65.423
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Week 20
|
-57.74 mg/dL
Standard Deviation 27.566
|
-82.50 mg/dL
Standard Deviation 61.125
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Week 24
|
-58.67 mg/dL
Standard Deviation 27.359
|
-80.13 mg/dL
Standard Deviation 65.627
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Week 28
|
-53.20 mg/dL
Standard Deviation 25.683
|
-78.29 mg/dL
Standard Deviation 69.825
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Week 32
|
-51.79 mg/dL
Standard Deviation 26.365
|
-71.29 mg/dL
Standard Deviation 72.972
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Week 36/Extension Period Day 1
|
-48.90 mg/dL
Standard Deviation 25.413
|
-71.21 mg/dL
Standard Deviation 73.255
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Extension Month 1
|
-60.42 mg/dL
Standard Deviation 27.882
|
-82.11 mg/dL
Standard Deviation 66.804
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Extension Month 2
|
-60.00 mg/dL
Standard Deviation 29.487
|
-62.20 mg/dL
Standard Deviation 30.809
|
|
Absolute Change From Baseline in Fasting ANGPTL3 Over Time
Change at Extension Month 3
|
-57.72 mg/dL
Standard Deviation 27.768
|
-81.60 mg/dL
Standard Deviation 67.042
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Week 4
|
-22.66 percentage change
Standard Deviation 20.417
|
-13.56 percentage change
Standard Deviation 16.687
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Week 8
|
-24.57 percentage change
Standard Deviation 14.851
|
-26.12 percentage change
Standard Deviation 14.166
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Week 12
|
-24.18 percentage change
Standard Deviation 14.824
|
-29.53 percentage change
Standard Deviation 15.714
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Week 16
|
-32.61 percentage change
Standard Deviation 13.562
|
-33.44 percentage change
Standard Deviation 16.671
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Week 20
|
-39.24 percentage change
Standard Deviation 12.601
|
-34.47 percentage change
Standard Deviation 14.887
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Week 24
|
-34.37 percentage change
Standard Deviation 24.533
|
-32.31 percentage change
Standard Deviation 14.577
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Week 28
|
-36.28 percentage change
Standard Deviation 15.326
|
-30.68 percentage change
Standard Deviation 21.968
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Week 32
|
-27.11 percentage change
Standard Deviation 15.920
|
-28.24 percentage change
Standard Deviation 20.822
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Week 36/Extension Period Day 1
|
-21.81 percentage change
Standard Deviation 13.064
|
-26.17 percentage change
Standard Deviation 17.824
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Extension Month 1
|
-32.88 percentage change
Standard Deviation 21.132
|
-32.97 percentage change
Standard Deviation 20.864
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Extension Month 2
|
-36.47 percentage change
Standard Deviation 15.287
|
-38.39 percentage change
Standard Deviation 15.463
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Extension Month 3
|
-26.79 percentage change
Standard Deviation 13.649
|
-36.12 percentage change
Standard Deviation 14.355
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Extension Month 6
|
-29.36 percentage change
Standard Deviation 20.417
|
-37.00 percentage change
Standard Deviation 11.472
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Extension Month 9
|
-40.36 percentage change
Standard Deviation 15.728
|
-34.87 percentage change
Standard Deviation 16.299
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Extension Month 12
|
-28.72 percentage change
Standard Deviation 28.370
|
-37.07 percentage change
Standard Deviation 10.802
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Extension Month 15
|
-35.58 percentage change
Standard Deviation 21.948
|
-35.86 percentage change
Standard Deviation 17.353
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Extension Month 18
|
-29.84 percentage change
Standard Deviation 10.307
|
-39.57 percentage change
Standard Deviation 5.181
|
|
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Change at Extension Month 21
|
-33.60 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-37.86 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Week 4
|
-39.14 mg/dL
Standard Deviation 35.959
|
-35.31 mg/dL
Standard Deviation 43.029
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Week 8
|
-60.46 mg/dL
Standard Deviation 45.415
|
-62.98 mg/dL
Standard Deviation 45.343
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Week 12
|
-63.26 mg/dL
Standard Deviation 66.166
|
-79.13 mg/dL
Standard Deviation 59.215
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Week 16
|
-76.58 mg/dL
Standard Deviation 58.965
|
-79.94 mg/dL
Standard Deviation 47.484
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Week 20
|
-96.76 mg/dL
Standard Deviation 72.475
|
-89.02 mg/dL
Standard Deviation 51.091
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Week 24
|
-87.06 mg/dL
Standard Deviation 93.621
|
-83.00 mg/dL
Standard Deviation 55.282
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Week 28
|
-93.94 mg/dL
Standard Deviation 79.427
|
-67.99 mg/dL
Standard Deviation 51.519
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Week 32
|
-70.86 mg/dL
Standard Deviation 78.104
|
-65.27 mg/dL
Standard Deviation 62.697
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Week 36/Extension Period Day 1
|
-55.24 mg/dL
Standard Deviation 60.876
|
-58.07 mg/dL
Standard Deviation 41.244
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Extension Month 1
|
-76.99 mg/dL
Standard Deviation 67.633
|
-76.87 mg/dL
Standard Deviation 58.747
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Extension Month 2
|
-85.06 mg/dL
Standard Deviation 61.798
|
-100.21 mg/dL
Standard Deviation 51.005
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Extension Month 3
|
-66.52 mg/dL
Standard Deviation 75.400
|
-86.02 mg/dL
Standard Deviation 40.782
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Extension Month 6
|
-73.48 mg/dL
Standard Deviation 88.362
|
-95.01 mg/dL
Standard Deviation 51.185
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Extension Month 9
|
-101.70 mg/dL
Standard Deviation 83.541
|
-93.98 mg/dL
Standard Deviation 61.071
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Extension Month 12
|
-77.07 mg/dL
Standard Deviation 118.653
|
-93.29 mg/dL
Standard Deviation 53.665
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Extension Month 15
|
-67.85 mg/dL
Standard Deviation 53.536
|
-95.50 mg/dL
Standard Deviation 74.478
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Extension Month 18
|
-53.90 mg/dL
Standard Deviation 42.896
|
-59.30 mg/dL
Standard Deviation 29.280
|
|
Absolute Change From Baseline in Fasting Total ApoB Over Time
Change at Extension Month 21
|
-84.00 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-39.00 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Week 4
|
-29.86 percentage change
Standard Deviation 25.175
|
-31.21 percentage change
Standard Deviation 13.064
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Week 8
|
-23.71 percentage change
Standard Deviation 33.894
|
-31.20 percentage change
Standard Deviation 13.315
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Week 12
|
-24.48 percentage change
Standard Deviation 22.696
|
-28.31 percentage change
Standard Deviation 19.736
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Week 16
|
-27.57 percentage change
Standard Deviation 26.780
|
-30.91 percentage change
Standard Deviation 18.858
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Week 20
|
-29.20 percentage change
Standard Deviation 28.775
|
-32.74 percentage change
Standard Deviation 16.100
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Week 24
|
-28.40 percentage change
Standard Deviation 26.642
|
-26.79 percentage change
Standard Deviation 19.501
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Week 28
|
-23.75 percentage change
Standard Deviation 23.836
|
-23.26 percentage change
Standard Deviation 19.538
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Week 32
|
-20.03 percentage change
Standard Deviation 22.396
|
-19.41 percentage change
Standard Deviation 21.107
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Week 36/Extension Period Day 1
|
-16.11 percentage change
Standard Deviation 24.469
|
-18.85 percentage change
Standard Deviation 19.893
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Extension Month 1
|
-32.00 percentage change
Standard Deviation 22.504
|
-28.00 percentage change
Standard Deviation 17.379
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Extension Month 2
|
-30.22 percentage change
Standard Deviation 24.818
|
-34.01 percentage change
Standard Deviation 11.100
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Extension Month 3
|
-28.11 percentage change
Standard Deviation 21.782
|
-23.57 percentage change
Standard Deviation 16.735
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Extension Month 6
|
-34.13 percentage change
Standard Deviation 20.060
|
-29.95 percentage change
Standard Deviation 7.836
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Extension Month 9
|
-33.76 percentage change
Standard Deviation 21.895
|
-35.01 percentage change
Standard Deviation 11.163
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Extension Month 12
|
-34.53 percentage change
Standard Deviation 24.550
|
-34.89 percentage change
Standard Deviation 19.870
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Extension Month 15
|
-39.46 percentage change
Standard Deviation 20.759
|
-34.61 percentage change
Standard Deviation 18.802
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Extension Month 18
|
-28.70 percentage change
Standard Deviation 15.714
|
-28.37 percentage change
Standard Deviation 20.700
|
|
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Change at Extension Month 21
|
-19.30 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-55.36 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Week 4
|
-15.2 mg/dL
Standard Deviation 15.44
|
-12.4 mg/dL
Standard Deviation 6.09
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Week 8
|
-14.4 mg/dL
Standard Deviation 17.70
|
-12.8 mg/dL
Standard Deviation 7.34
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Week 12
|
-13.0 mg/dL
Standard Deviation 13.95
|
-11.7 mg/dL
Standard Deviation 8.28
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Week 16
|
-15.2 mg/dL
Standard Deviation 15.37
|
-12.6 mg/dL
Standard Deviation 7.98
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Week 20
|
-16.5 mg/dL
Standard Deviation 16.24
|
-13.0 mg/dL
Standard Deviation 7.07
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Week 24
|
-15.0 mg/dL
Standard Deviation 16.48
|
-11.6 mg/dL
Standard Deviation 7.55
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Week 28
|
-12.6 mg/dL
Standard Deviation 13.79
|
-9.8 mg/dL
Standard Deviation 7.41
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Week 32
|
-11.0 mg/dL
Standard Deviation 11.84
|
-8.0 mg/dL
Standard Deviation 7.60
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Week 36/Extension Period Day 1
|
-8.2 mg/dL
Standard Deviation 13.82
|
-7.8 mg/dL
Standard Deviation 8.27
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Extension Month 1
|
-17.0 mg/dL
Standard Deviation 13.64
|
-12.1 mg/dL
Standard Deviation 10.46
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Extension Month 2
|
-15.8 mg/dL
Standard Deviation 15.13
|
-13.8 mg/dL
Standard Deviation 7.19
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Extension Month 3
|
-14.9 mg/dL
Standard Deviation 13.00
|
-9.8 mg/dL
Standard Deviation 7.21
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Extension Month 6
|
-16.7 mg/dL
Standard Deviation 12.95
|
-13.0 mg/dL
Standard Deviation 6.32
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Extension Month 9
|
-17.8 mg/dL
Standard Deviation 13.70
|
-14.9 mg/dL
Standard Deviation 8.36
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Extension Month 12
|
-17.6 mg/dL
Standard Deviation 13.92
|
-15.4 mg/dL
Standard Deviation 11.88
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Extension Month 15
|
-19.3 mg/dL
Standard Deviation 13.98
|
-16.3 mg/dL
Standard Deviation 12.15
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Extension Month 18
|
-17.3 mg/dL
Standard Deviation 9.45
|
-14.0 mg/dL
Standard Deviation 13.45
|
|
Absolute Change From Baseline in Fasting HDL-C Over Time
Change at Extension Month 21
|
-11.0 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-31.0 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 4
|
-28.56 percentage change
Standard Deviation 25.449
|
-22.46 percentage change
Standard Deviation 17.626
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 8
|
-29.37 percentage change
Standard Deviation 19.205
|
-31.46 percentage change
Standard Deviation 18.442
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 12
|
-26.16 percentage change
Standard Deviation 18.653
|
-33.40 percentage change
Standard Deviation 18.451
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 16
|
-37.63 percentage change
Standard Deviation 18.082
|
-41.98 percentage change
Standard Deviation 19.555
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 20
|
-47.01 percentage change
Standard Deviation 12.407
|
-43.09 percentage change
Standard Deviation 16.064
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 24
|
-38.35 percentage change
Standard Deviation 27.233
|
-40.27 percentage change
Standard Deviation 17.340
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 28
|
-42.36 percentage change
Standard Deviation 15.456
|
-35.74 percentage change
Standard Deviation 25.148
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 32
|
-31.82 percentage change
Standard Deviation 18.125
|
-33.96 percentage change
Standard Deviation 23.654
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 36/Extension Period Day 1
|
-25.35 percentage change
Standard Deviation 15.345
|
-30.48 percentage change
Standard Deviation 21.266
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 1
|
-38.56 percentage change
Standard Deviation 20.841
|
-41.71 percentage change
Standard Deviation 23.691
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 2
|
-40.98 percentage change
Standard Deviation 18.473
|
-42.66 percentage change
Standard Deviation 19.719
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 3
|
-33.13 percentage change
Standard Deviation 14.339
|
-42.82 percentage change
Standard Deviation 17.366
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 6
|
-34.21 percentage change
Standard Deviation 21.376
|
-41.38 percentage change
Standard Deviation 15.704
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 9
|
-44.79 percentage change
Standard Deviation 16.769
|
-41.61 percentage change
Standard Deviation 18.119
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 12
|
-32.37 percentage change
Standard Deviation 33.802
|
-43.93 percentage change
Standard Deviation 11.998
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 15
|
-45.02 percentage change
Standard Deviation 24.453
|
-42.70 percentage change
Standard Deviation 20.219
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 18
|
-39.09 percentage change
Standard Deviation 10.664
|
-50.18 percentage change
Standard Deviation 8.152
|
|
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 21
|
-47.02 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-52.63 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 4
|
-78.1 mg/dL
Standard Deviation 69.62
|
-101.8 mg/dL
Standard Deviation 87.64
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 8
|
-114.0 mg/dL
Standard Deviation 91.37
|
-123.0 mg/dL
Standard Deviation 91.15
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 12
|
-110.7 mg/dL
Standard Deviation 129.72
|
-160.9 mg/dL
Standard Deviation 139.64
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 16
|
-136.3 mg/dL
Standard Deviation 104.65
|
-181.0 mg/dL
Standard Deviation 138.72
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 20
|
-183.8 mg/dL
Standard Deviation 125.14
|
-199.0 mg/dL
Standard Deviation 135.74
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 24
|
-151.9 mg/dL
Standard Deviation 164.87
|
-178.7 mg/dL
Standard Deviation 139.40
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 28
|
-173.1 mg/dL
Standard Deviation 143.21
|
-144.8 mg/dL
Standard Deviation 145.65
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 32
|
-131.7 mg/dL
Standard Deviation 135.84
|
-135.7 mg/dL
Standard Deviation 131.67
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Week 36/Extension Period Day 1
|
-102.9 mg/dL
Standard Deviation 119.50
|
-121.9 mg/dL
Standard Deviation 111.79
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 1
|
-144.4 mg/dL
Standard Deviation 120.85
|
-175.7 mg/dL
Standard Deviation 153.10
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 2
|
-151.7 mg/dL
Standard Deviation 123.14
|
-196.6 mg/dL
Standard Deviation 139.03
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 3
|
-122.8 mg/dL
Standard Deviation 124.37
|
-181.4 mg/dL
Standard Deviation 118.04
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 6
|
-132.1 mg/dL
Standard Deviation 151.85
|
-187.6 mg/dL
Standard Deviation 137.45
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 9
|
-177.6 mg/dL
Standard Deviation 145.59
|
-200.1 mg/dL
Standard Deviation 155.48
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 12
|
-132.9 mg/dL
Standard Deviation 217.41
|
-195.0 mg/dL
Standard Deviation 137.50
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 15
|
-132.0 mg/dL
Standard Deviation 102.55
|
-198.3 mg/dL
Standard Deviation 184.29
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 18
|
-113.0 mg/dL
Standard Deviation 98.50
|
-116.7 mg/dL
Standard Deviation 54.10
|
|
Absolute Change From Baseline in Fasting Non-HDL-C Over Time
Change at Extension Month 21
|
-205.0 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-80.0 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Week 4
|
-31.73 percentage change
Standard Deviation 33.616
|
-35.74 percentage change
Standard Deviation 22.552
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Week 8
|
-33.78 percentage change
Standard Deviation 23.700
|
-38.46 percentage change
Standard Deviation 27.771
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Week 12
|
-38.87 percentage change
Standard Deviation 27.827
|
-41.43 percentage change
Standard Deviation 21.979
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Week 16
|
-41.91 percentage change
Standard Deviation 26.896
|
-42.73 percentage change
Standard Deviation 21.040
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Week 20
|
-37.96 percentage change
Standard Deviation 37.764
|
-32.93 percentage change
Standard Deviation 22.929
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Week 24
|
-45.76 percentage change
Standard Deviation 29.715
|
-36.01 percentage change
Standard Deviation 23.463
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Week 28
|
-38.67 percentage change
Standard Deviation 30.495
|
-39.89 percentage change
Standard Deviation 18.327
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Week 32
|
-35.52 percentage change
Standard Deviation 40.943
|
-33.58 percentage change
Standard Deviation 19.943
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Week 36/Extension Period Day 1
|
-39.50 percentage change
Standard Deviation 26.841
|
-29.98 percentage change
Standard Deviation 27.703
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Extension Month 1
|
-47.09 percentage change
Standard Deviation 25.511
|
-40.22 percentage change
Standard Deviation 27.818
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Extension Month 2
|
-41.65 percentage change
Standard Deviation 25.924
|
-42.87 percentage change
Standard Deviation 25.178
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Extension Month 3
|
-39.88 percentage change
Standard Deviation 30.556
|
-40.42 percentage change
Standard Deviation 23.416
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Extension Month 6
|
-39.23 percentage change
Standard Deviation 25.894
|
-42.81 percentage change
Standard Deviation 13.879
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Extension Month 9
|
-44.60 percentage change
Standard Deviation 25.073
|
-43.23 percentage change
Standard Deviation 23.332
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Extension Month 12
|
-36.90 percentage change
Standard Deviation 33.563
|
-40.51 percentage change
Standard Deviation 24.667
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Extension Month 15
|
-27.93 percentage change
Standard Deviation 30.727
|
-39.31 percentage change
Standard Deviation 26.494
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Extension Month 18
|
-39.68 percentage change
Standard Deviation 31.466
|
-46.88 percentage change
Standard Deviation 11.298
|
|
Percent Change From Baseline in Fasting Very-Low-Density Lipoprotein-Cholesterol (VLDL-C) Over Time
Change at Extension Month 21
|
-73.08 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-41.18 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Week 4
|
-13.7 mg/dL
Standard Deviation 17.35
|
-9.4 mg/dL
Standard Deviation 10.82
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Week 8
|
-13.8 mg/dL
Standard Deviation 17.59
|
-10.6 mg/dL
Standard Deviation 9.88
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Week 12
|
-15.8 mg/dL
Standard Deviation 20.20
|
-10.6 mg/dL
Standard Deviation 9.88
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Week 16
|
-17.3 mg/dL
Standard Deviation 21.80
|
-10.9 mg/dL
Standard Deviation 10.30
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Week 20
|
-17.8 mg/dL
Standard Deviation 23.37
|
-9.3 mg/dL
Standard Deviation 9.62
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Week 24
|
-18.8 mg/dL
Standard Deviation 22.79
|
-10.2 mg/dL
Standard Deviation 10.26
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Week 28
|
-17.1 mg/dL
Standard Deviation 21.52
|
-10.4 mg/dL
Standard Deviation 10.06
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Week 32
|
-15.9 mg/dL
Standard Deviation 21.65
|
-9.2 mg/dL
Standard Deviation 10.00
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Week 36/Extension Period Day 1
|
-16.1 mg/dL
Standard Deviation 20.06
|
-8.6 mg/dL
Standard Deviation 11.07
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Extension Month 1
|
-18.2 mg/dL
Standard Deviation 20.33
|
-11.1 mg/dL
Standard Deviation 11.03
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Extension Month 2
|
-17.1 mg/dL
Standard Deviation 21.14
|
-12.0 mg/dL
Standard Deviation 10.99
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Extension Month 3
|
-16.3 mg/dL
Standard Deviation 21.11
|
-10.6 mg/dL
Standard Deviation 10.51
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Extension Month 6
|
-16.0 mg/dL
Standard Deviation 20.50
|
-11.0 mg/dL
Standard Deviation 9.15
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Extension Month 9
|
-18.1 mg/dL
Standard Deviation 22.75
|
-11.6 mg/dL
Standard Deviation 10.90
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Extension Month 12
|
-16.8 mg/dL
Standard Deviation 23.23
|
-11.1 mg/dL
Standard Deviation 11.43
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Extension Month 15
|
-9.5 mg/dL
Standard Deviation 14.79
|
-11.1 mg/dL
Standard Deviation 11.89
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Extension Month 18
|
-16.7 mg/dL
Standard Deviation 19.35
|
-7.7 mg/dL
Standard Deviation 2.52
|
|
Absolute Change From Baseline in Fasting VLDL-C Over Time
Change at Extension Month 21
|
-38.0 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-7.0 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Week 4
|
-28.71 percentage change
Standard Deviation 23.883
|
-22.78 percentage change
Standard Deviation 15.915
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Week 8
|
-30.34 percentage change
Standard Deviation 17.188
|
-31.13 percentage change
Standard Deviation 16.009
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Week 12
|
-26.92 percentage change
Standard Deviation 17.798
|
-32.98 percentage change
Standard Deviation 17.770
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Week 16
|
-36.70 percentage change
Standard Deviation 17.813
|
-40.23 percentage change
Standard Deviation 18.262
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Week 20
|
-45.35 percentage change
Standard Deviation 13.825
|
-41.16 percentage change
Standard Deviation 14.789
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Week 24
|
-37.19 percentage change
Standard Deviation 26.233
|
-38.43 percentage change
Standard Deviation 16.019
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Week 28
|
-40.24 percentage change
Standard Deviation 14.755
|
-32.99 percentage change
Standard Deviation 22.587
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Week 32
|
-30.44 percentage change
Standard Deviation 15.765
|
-31.35 percentage change
Standard Deviation 21.496
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Week 36/Extension Period Day 1
|
-23.84 percentage change
Standard Deviation 14.448
|
-28.27 percentage change
Standard Deviation 18.955
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Extension Month 1
|
-38.05 percentage change
Standard Deviation 19.686
|
-39.69 percentage change
Standard Deviation 21.726
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Extension Month 2
|
-39.54 percentage change
Standard Deviation 18.333
|
-41.14 percentage change
Standard Deviation 18.174
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Extension Month 3
|
-33.00 percentage change
Standard Deviation 14.076
|
-40.24 percentage change
Standard Deviation 15.197
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Extension Month 6
|
-33.72 percentage change
Standard Deviation 19.469
|
-39.62 percentage change
Standard Deviation 13.901
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Extension Month 9
|
-44.42 percentage change
Standard Deviation 15.779
|
-40.84 percentage change
Standard Deviation 16.580
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Extension Month 12
|
-33.08 percentage change
Standard Deviation 30.808
|
-42.02 percentage change
Standard Deviation 11.373
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Extension Month 15
|
-44.41 percentage change
Standard Deviation 23.042
|
-41.46 percentage change
Standard Deviation 20.037
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Extension Month 18
|
-37.26 percentage change
Standard Deviation 9.306
|
-47.38 percentage change
Standard Deviation 9.357
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) Over Time
Change at Extension Month 21
|
-43.81 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-53.37 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Week 4
|
-93.3 mg/dL
Standard Deviation 73.05
|
-114.2 mg/dL
Standard Deviation 89.54
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Week 8
|
-128.4 mg/dL
Standard Deviation 87.47
|
-135.8 mg/dL
Standard Deviation 88.98
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Week 12
|
-123.7 mg/dL
Standard Deviation 129.62
|
-172.6 mg/dL
Standard Deviation 141.46
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Week 16
|
-151.6 mg/dL
Standard Deviation 106.76
|
-193.6 mg/dL
Standard Deviation 139.58
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Week 20
|
-200.3 mg/dL
Standard Deviation 123.96
|
-212.0 mg/dL
Standard Deviation 138.10
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Week 24
|
-166.9 mg/dL
Standard Deviation 168.36
|
-190.2 mg/dL
Standard Deviation 140.70
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Week 28
|
-185.8 mg/dL
Standard Deviation 139.67
|
-154.6 mg/dL
Standard Deviation 150.40
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Week 32
|
-142.7 mg/dL
Standard Deviation 136.57
|
-143.7 mg/dL
Standard Deviation 133.19
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Week 36/Extension Period Day 1
|
-111.1 mg/dL
Standard Deviation 122.51
|
-129.7 mg/dL
Standard Deviation 112.35
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Extension Month 1
|
-161.4 mg/dL
Standard Deviation 123.97
|
-187.8 mg/dL
Standard Deviation 154.16
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Extension Month 2
|
-167.4 mg/dL
Standard Deviation 125.09
|
-210.4 mg/dL
Standard Deviation 140.11
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Extension Month 3
|
-137.7 mg/dL
Standard Deviation 122.93
|
-191.2 mg/dL
Standard Deviation 116.60
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Extension Month 6
|
-148.8 mg/dL
Standard Deviation 151.75
|
-200.6 mg/dL
Standard Deviation 134.86
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Extension Month 9
|
-195.3 mg/dL
Standard Deviation 143.95
|
-215.0 mg/dL
Standard Deviation 156.35
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Extension Month 12
|
-150.4 mg/dL
Standard Deviation 219.70
|
-210.4 mg/dL
Standard Deviation 140.22
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Extension Month 15
|
-151.3 mg/dL
Standard Deviation 101.84
|
-214.5 mg/dL
Standard Deviation 189.17
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Extension Month 18
|
-130.3 mg/dL
Standard Deviation 94.19
|
-130.7 mg/dL
Standard Deviation 46.32
|
|
Absolute Change From Baseline in Fasting TC Over Time
Change at Extension Month 21
|
-43.81 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-53.37 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Week 4
|
-33.93 percentage change
Standard Deviation 24.238
|
-32.63 percentage change
Standard Deviation 18.963
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Week 8
|
-32.97 percentage change
Standard Deviation 17.992
|
-34.66 percentage change
Standard Deviation 23.930
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Week 12
|
-37.71 percentage change
Standard Deviation 23.891
|
-38.76 percentage change
Standard Deviation 16.770
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Week 16
|
-43.08 percentage change
Standard Deviation 20.862
|
-40.09 percentage change
Standard Deviation 15.672
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Week 20
|
-38.71 percentage change
Standard Deviation 29.791
|
-28.05 percentage change
Standard Deviation 24.021
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Week 24
|
-46.56 percentage change
Standard Deviation 24.519
|
-30.88 percentage change
Standard Deviation 25.683
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Week 28
|
-38.60 percentage change
Standard Deviation 27.162
|
-37.62 percentage change
Standard Deviation 15.234
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Week 32
|
-37.71 percentage change
Standard Deviation 31.286
|
-30.24 percentage change
Standard Deviation 16.575
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Week 36/Extension Period Day 1
|
-40.04 percentage change
Standard Deviation 20.173
|
-25.23 percentage change
Standard Deviation 32.202
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Extension Month 1
|
-48.10 percentage change
Standard Deviation 19.677
|
-37.01 percentage change
Standard Deviation 26.980
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Extension Month 2
|
-42.78 percentage change
Standard Deviation 21.043
|
-40.19 percentage change
Standard Deviation 25.629
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Extension Month 3
|
-39.91 percentage change
Standard Deviation 25.236
|
-36.59 percentage change
Standard Deviation 21.725
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Extension Month 6
|
-39.48 percentage change
Standard Deviation 22.721
|
-37.04 percentage change
Standard Deviation 12.764
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Extension Month 9
|
-45.37 percentage change
Standard Deviation 20.745
|
-39.16 percentage change
Standard Deviation 24.524
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Extension Month 12
|
-37.43 percentage change
Standard Deviation 28.185
|
-39.65 percentage change
Standard Deviation 20.454
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Extension Month 15
|
-31.41 percentage change
Standard Deviation 26.828
|
-38.41 percentage change
Standard Deviation 22.277
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Extension Month 18
|
-27.97 percentage change
Standard Deviation 42.070
|
-48.52 percentage change
Standard Deviation 7.000
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) Over Time
Change at Extension Month 21
|
-64.07 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-36.10 percentage change
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 (Day 1 of Extension Period), Extension Months 1, 2, 3, 6, 9, 12, 15, 18, 21Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP. Participants with an assessment at given time period.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Week 4
|
-53.86 mg/dL
Standard Deviation 55.016
|
-37.20 mg/dL
Standard Deviation 30.916
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Week 8
|
-53.31 mg/dL
Standard Deviation 60.595
|
-41.79 mg/dL
Standard Deviation 29.249
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Week 12
|
-62.75 mg/dL
Standard Deviation 74.300
|
-42.65 mg/dL
Standard Deviation 27.545
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Week 16
|
-71.75 mg/dL
Standard Deviation 80.566
|
-42.09 mg/dL
Standard Deviation 27.530
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Week 20
|
-71.00 mg/dL
Standard Deviation 89.060
|
-36.65 mg/dL
Standard Deviation 34.274
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Week 24
|
-77.86 mg/dL
Standard Deviation 85.043
|
-40.42 mg/dL
Standard Deviation 34.591
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Week 28
|
-68.38 mg/dL
Standard Deviation 81.190
|
-42.54 mg/dL
Standard Deviation 28.038
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Week 32
|
-64.86 mg/dL
Standard Deviation 79.193
|
-35.98 mg/dL
Standard Deviation 26.881
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Week 36/Extension Period Day 1
|
-65.53 mg/dL
Standard Deviation 72.904
|
-32.87 mg/dL
Standard Deviation 39.829
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Extension Month 1
|
-76.20 mg/dL
Standard Deviation 72.636
|
-45.87 mg/dL
Standard Deviation 40.724
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Extension Month 2
|
-71.31 mg/dL
Standard Deviation 78.207
|
-49.96 mg/dL
Standard Deviation 38.154
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Extension Month 3
|
-66.53 mg/dL
Standard Deviation 79.422
|
-41.87 mg/dL
Standard Deviation 32.619
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Extension Month 6
|
-65.42 mg/dL
Standard Deviation 77.178
|
-40.66 mg/dL
Standard Deviation 26.774
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Extension Month 9
|
-75.64 mg/dL
Standard Deviation 87.304
|
-47.31 mg/dL
Standard Deviation 37.028
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Extension Month 12
|
-68.09 mg/dL
Standard Deviation 88.590
|
-46.92 mg/dL
Standard Deviation 34.988
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Extension Month 15
|
-42.98 mg/dL
Standard Deviation 48.869
|
-46.67 mg/dL
Standard Deviation 35.437
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Extension Month 18
|
-46.60 mg/dL
Standard Deviation 81.396
|
-43.67 mg/dL
Standard Deviation 22.759
|
|
Absolute Change From Baseline in Fasting TG Over Time
Change at Extension Month 21
|
-64.07 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
-36.10 mg/dL
Standard Deviation NA
1 participant analyzed (standard deviation cannot be calculated for 1 participant)
|
SECONDARY outcome
Timeframe: From first dose of study drug up to Week 36 (initial treatment period), and up to Month 24 (extension period)Population: Safety Analysis Set: All participants who received at least 1 dose of IP.
An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is an AE occurring during any study phase that: results in death; is immediately life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medically important event or reaction that may require medical intervention to prevent one of the outcomes listed above. AEs are considered treatment-related if the relationship to the study drug is 'possibly related', 'probably related'. A TEAE is defined as an AE that occurs following IP administration or a pre-existing condition exacerbated following IP administration. Injection site reactions are assessed at every visit starting on Day 1 and include any Preferred Term containing 'Injection Site'.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs
|
7 Participants
|
7 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Serious TEAEs
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Study drug-related TEAEs
|
1 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs leading to study drug discontinuation
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Study drug-related TEAEs leading to discontinuation of study drug
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Injection site reaction
|
1 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Maximum severity of TEAE = Mild
|
3 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Maximum severity of TEAE = Moderate
|
3 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Maximum severity of TEAE = Severe
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Weeks 4, 12, 16, 24 (initial treatment period), Week 36/Day 1, Months 1, 3, 6, 9, 12, 15, 18, 21 (extension period)Population: Safety Analysis Set: All participants who received at least 1 dose of IP. Participants with an assessment at given time point.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Extension Period Month 1 · Negative
|
9 Participants
|
9 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Extension Period Month 3 · Positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Extension Period Month 3 · Negative
|
9 Participants
|
9 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Extension Period Month 6 · Positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Extension Period Month 6 · Negative
|
9 Participants
|
9 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Extension Period Month 9 · Positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Extension Period Month 9 · Negative
|
9 Participants
|
9 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Extension Period Month 12 · Positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Extension Period Month 12 · Negative
|
9 Participants
|
8 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Extension Period Month 15 · Positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Extension Period Month 15 · Negative
|
6 Participants
|
8 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Extension Period Month 18 · Positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Extension Period Month 18 · Negative
|
2 Participants
|
3 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Extension Period Month 21 · Positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Extension Period Month 21 · Negative
|
1 Participants
|
1 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Week 36, Extension Period Day 1 · Negative
|
9 Participants
|
9 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Extension Period Month 1 · Positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Week 4 · Positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Week 4 · Negative
|
9 Participants
|
9 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Week 12 · Positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Week 12 · Negative
|
8 Participants
|
9 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Week 16 · Positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Week 16 · Negative
|
9 Participants
|
9 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Week 24 · Positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Week 24 · Negative
|
9 Participants
|
9 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Week 36, Extension Period Day 1 · Positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Day 1 · Positive
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to ARO-ANG3 Over Time
Day 1 · Negative
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP.
Apheresis is the extracorporeal process of removing one or more blood constituents from whole blood and returning the remainder to the circulation.The National Lipid Association outlines eligibility criteria for apheresis, particularly for patients with familial hypercholesterolemia who have not achieved target LDL cholesterol levels despite maximally tolerated pharmacotherapy. LDL-C ≥ 300 mg/dL is a criterion.
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Percentage of Participants Meeting United States National Lipid Association Apheresis Eligibility Criteria of LDL-C ≥ 300 mg/dL at Week 24
|
33.3 percentage of participants
|
44.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis Set: All randomized participants who receive at least 1 dose of IP.
Apheresis is the extracorporeal process of removing one or more blood constituents from whole blood and returning the remainder to the circulation. The European Union (EU) apheresis eligibility criteria (per German Apheresis Working Group) include the following categories: * A patient with primary cardiovascular disease (CVD) prevention is considered as meeting German apheresis eligibility criteria if LDL-C \>160 mg/dL * A patient with secondary CVD prevention is considered as meeting German apheresis eligibility criteria if LDL-C \>120 mg/dL
Outcome measures
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 Participants
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Percentage of Participants Meeting European Union (EU) Apheresis Eligibility Criteria Per German Apheresis Working Group at Week 24
LDL-C >160 mg/dL (>4.14 mmol/L)
|
55.6 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants Meeting European Union (EU) Apheresis Eligibility Criteria Per German Apheresis Working Group at Week 24
LDL-C >120 mg/dL (>3.11 mmol/L)
|
55.6 percentage of participants
|
77.8 percentage of participants
|
Adverse Events
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 participants at risk
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 participants at risk
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Cardiac disorders
Coronary artery disease
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Surgical and medical procedures
Abortion induced
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
Other adverse events
| Measure |
ARO-ANG3 200 mg/EXT ARO-ANG3 200 mg
n=9 participants at risk
Participants will be randomized to receive ARO-ANG3 200 mg subcutaneous (SC) injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
ARO-ANG3 300 mg / EXT ARO-ANG3 300 mg
n=9 participants at risk
Participants will be randomized to receive ARO-ANG3 300 mg SC injection on Day 1 and Day 84 during the initial 36 weeks of the study and on Day1 and Months 3, 6, 9, 12, 15, 18, and 21 of the extension period.
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Vascular disorders
Brachiocephalic vein stenosis
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
22.2%
2/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Investigations
International normalised ratio increased
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Metabolism and nutrition disorders
Dehydration
|
22.2%
2/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Nervous system disorders
Lethargy
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Nervous system disorders
Transient ischaemic attack
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Renal and urinary disorders
Renal artery arteriosclerosis
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Renal and urinary disorders
Renal atrophy
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Skin and subcutaneous tissue disorders
Eczema
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Cardiac disorders
Coronary artery disease
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Gastrointestinal disorders
Tongue geographic
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
General disorders
Injection site bruising
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
22.2%
2/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
General disorders
Injection site erythema
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
22.2%
2/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
General disorders
Injection site pain
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
22.2%
2/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
General disorders
Injection site reaction
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
General disorders
Fatigue
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
General disorders
Injection site oedema
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
General disorders
Peripheral swelling
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Infections and infestations
COVID-19
|
22.2%
2/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
33.3%
3/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Infections and infestations
Nasopharyngitis
|
22.2%
2/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
33.3%
3/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
33.3%
3/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Cardiac disorders
Angina pectoris
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Vascular disorders
Iliac artery stenosis
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
|
Vascular disorders
Jugular vein distension
|
0.00%
0/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
11.1%
1/9 • Up to 33 months: 36-Week Treatment Period plus 24-Month Extension Treatment Period
|
Additional Information
Chief Operating Officer
Arrowhead Pharmaceuticals, Inc.
Phone: 1 (626) 304-3400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor retains first right to publish results for this multi-center study, and thereafter can review results communications prior to release and can embargo communications regarding trial results for a period that is 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication of results but can require removal of its confidential information (excluding results).
- Publication restrictions are in place
Restriction type: OTHER