Study of ARO-ANG3 in Adults With Mixed Dyslipidemia | NCT04832971 | Trialant
NCT04832971
Sponsor
Arrowhead Pharmaceuticals
Status
Completed
Last Update Posted
Dec 3, 2025Actual
Enrollment
204Actual
Phase
Phase 2
Conditions
Mixed Dyslipidemia
Interventions
ARO-ANG3
Placebo
Countries
United States
Australia
Canada
New Zealand
Protocol Section
Identification Module
NCT ID
NCT04832971
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
AROANG3-2001
Secondary IDs
Not provided
Brief Title
Study of ARO-ANG3 in Adults With Mixed Dyslipidemia
Official Title
A Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-ANG3 in Adults With Mixed Dyslipidemia
Acronym
ARCHES-2
Organization
Arrowhead PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Dec 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 28, 2021Actual
Primary Completion Date
Aug 30, 2022Actual
Completion Date
Sep 25, 2024Actual
First Submitted Date
Apr 2, 2021
First Submission Date that Met QC Criteria
Apr 2, 2021
First Posted Date
Apr 6, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Nov 29, 2023
Results First Submitted that Met QC Criteria
Jan 12, 2024
Results First Posted Date
Jan 16, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 1, 2025
Last Update Posted Date
Dec 3, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Arrowhead PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of AROANG3-2001 is to evaluate the efficacy and safety of ARO-ANG3 in participants with mixed dyslipidemia. Participants will initially receive 2 subcutaneous injections of ARO-ANG3 or placebo. Participants who complete the double-blind treatment period may opt to continue in an open-label extension during which they will receive up to 8 doses of ARO-ANG3.
Detailed Description
Not provided
Conditions Module
Conditions
Mixed Dyslipidemia
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
204Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ARO-ANG3 50 mg
Experimental
Two doses of ARO-ANG3 by subcutaneous (sc) injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Drug: ARO-ANG3
ARO-ANG3 100 mg
Experimental
Two doses of ARO-ANG3 bysc injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Drug: ARO-ANG3
ARO-ANG3 200 mg
Experimental
Two doses of ARO-ANG3 by sc injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Drug: ARO-ANG3
Placebo
Placebo Comparator
Calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Drug: ARO-ANG3
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ARO-ANG3
Drug
ARO-ANG3 Injection
ARO-ANG3 100 mg
ARO-ANG3 200 mg
ARO-ANG3 50 mg
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Fasting TG at Week 24
Baseline, Week 24
Secondary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Fasting TG Over Time
Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24
Baseline, Week 24
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Based on medical history, evidence of triglycerides (TG) ≥ 150 mg/dL but ≤ 499 mg/dL
Fasting levels at Screening of LDL-C ≥ 70 mg/dL OR non-HDL-C ≥ 100 mg/dL after at least 4 weeks of stable diet and stable optimal statin therapy
Mean fasting TG ≥ 150 mg/dL and ≤ 499 mg/dL during Screening collected at two separate and consecutive visits and at least 7 days apart and not more than 17 days apart
Willing to follow diet counseling and maintain a stable diet per Investigator judgment based on local standard of care
Participants of childbearing potential must agree to use highly-effective contraception during the study and for at least 24 weeks from last dose of study medication
Women of childbearing potential must have a negative pregnancy test and cannot be breastfeeding
Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1
Men must not donate sperm during the study and for at least 24 weeks following the last dose of study medication
Able and willing to provide written informed consent and to comply with study requirements
Exclusion Criteria:
Current use or use within 365 days from Day 1 of any hepatocyte targeted siRNA or antisense oligonucleotide molecule
Active pancreatitis within 12 weeks prior to Day 1
Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study
Acute coronary syndrome event within 24 weeks of Day 1
Major surgery within 12 weeks of Day 1 or planned surgery during the study
Planned coronary intervention (e.g., stent placement or heart bypass) during the study
Uncontrolled hypertension
Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
Uncontrolled hypothyroidism or hyperthyroidism
Hemorrhagic stroke within 24 weeks of Day 1
History of bleeding diathesis or coagulopathy
Current diagnosis of nephrotic syndrome
Systemic use of corticosteroids or anabolic steroids within 4 weeks prior to Day 1 or planned use during the study
Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply)
Note: additional inclusion/exclusion criteria may apply per protocol
Rosenson RS, Gaudet D, Hegele RA, Ballantyne CM, Nicholls SJ, Lucas KJ, San Martin J, Zhou R, Muhsin M, Chang T, Hellawell J, Watts GF; ARCHES-2 Trial Team. Zodasiran, an RNAi Therapeutic Targeting ANGPTL3, for Mixed Hyperlipidemia. N Engl J Med. 2024 Sep 12;391(10):913-925. doi: 10.1056/NEJMoa2404147. Epub 2024 May 29.
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and/or Serious TEAEs up to Week 24
TEAEs are adverse events (AEs) that occur following IP administration or a pre-existing condition exacerbated following IP administration. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.
From first dose of IP up to Week 24
Number of Participants With TEAEs and/or SAEs Over Time in the Double-Blind Treatment Period
Adverse event (AE)=any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. TEAEs=AEs with onset after administration of the study drug, or when a pre-existing medical condition increases in severity or frequency after study drug administration. Serious adverse event (SAE)= an AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction.
up to Week 36 (double-blind treatment period)
Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension (OLE) Period
Adverse event (AE)=any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. TEAEs=AEs with onset after administration of the study drug, or when a pre-existing medical condition increases in severity or frequency after study drug administration. Serious adverse event (SAE)= an AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction.
From first dose of study drug in the OLE up to Month 24 (open-label extension)
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period
Baseline, OLE Baseline, Months 1-24 (open-label extension)
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period
Baseline, OLE Baseline, Months 1-24 (open-label extension)
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period
Baseline, OLE Baseline, Months 1-24 (open-label extension)
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period
Baseline, OLE Baseline, Months 1-24 (open-label extension)
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period
Baseline, OLE Baseline, Months 1-24 (open-label extension)
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period
Baseline, OLE Baseline, Months 1-24 (open-label extension)
Hialeah
Florida
33012
United States
Research Site 17
Miami
Florida
33144
United States
Research Site 8
Port Orange
Florida
32127
United States
Research Site 24
Minneapolis
Minnesota
55455
United States
Research Site 10
Omaha
Nebraska
68114
United States
Research Site 23
Las Vegas
Nevada
89121
United States
Research Site 22
New York
New York
10029
United States
Research Site 15
Greensboro
North Carolina
27408
United States
Research Site 2
Morehead City
North Carolina
28557
United States
Research Site 1
Marion
Ohio
43302
United States
Research Site 4
Camp Hill
Pennsylvania
17011
United States
Research Site 11
Houston
Texas
77030
United States
Research Site 6
Blacktown
New South Wales
2148
Australia
Research Site 21
Sippy Downs
Queensland
4556
Australia
Research Site 18
Nedlands
6009
Australia
Research Site 25
London
Ontario
N6A 5A5
Canada
Research Site 16
Chicoutimi
Quebec
G7H 7K9
Canada
Research Site 12
Québec
G1G 3Z4
Canada
Research Site 9
Québec
H7T2P5
Canada
Research Site 19
Birkenhead
0626
New Zealand
Research Site 13
Christchurch
8011
New Zealand
Research Site 20
Hamilton
3200
New Zealand
Research Site 14
Rotorua
3010
New Zealand
Derived
Dimitriadis K, Theofilis P, Iliakis P, Pyrpyris N, Dri E, Sakalidis A, Soulaidopoulos S, Tsioufis P, Fragkoulis C, Chrysohoou C, Tsiachris D, Tsioufis K. Management of dyslipidemia in coronary artery disease: the present and the future. Coron Artery Dis. 2024 Sep 1;35(6):516-524. doi: 10.1097/MCA.0000000000001375. Epub 2024 Apr 29.
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
FG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
FG003
ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
FG004
Placebo/ARO-ANG3 50 mg
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
FG005
ARO-ANG3 50 mg/ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
FG006
Placebo/ARO-ANG3 100 mg
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
FG007
ARO-ANG3 100 mg/ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
FG008
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
FG009
ARO-ANG3 200mg/ARO-ANG3 200mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
FG00051 subjects
FG00151 subjects
FG00251 subjects
FG00351 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
Completed Double-Blind (DB) Treatment Period
FG00048 subjects
FG00146 subjects
FG00247 subjects
FG00350 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0003 subjects
FG0015 subjects
FG0024 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG0031 subjects
FG004
Other, Not Specified
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Open-Label Extension (OLE) Period
Type
Comment
Milestone Data
STARTED
Enrolled in OLE Treatment Period
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00413 subjects
FG00536 subjects
FG00614 subjects
FG00739 subjects
FG00813 subjects
FG00941 subjects
COMPLETED
Completed 24-month Treatment at OLE Treatment Period
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
BG001
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
BG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
BG003
ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00051
BG00151
BG00251
BG00351
BG004204
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00060.2± 11.30
BG00160.4± 12.68
BG00260.0± 9.89
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00024
BG00125
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00012
BG00112
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
White
BG00048
BG00149
BG002
Mean Triglycerides (TG) at Baseline
Mean
Standard Deviation
mg/dL
Title
Denominators
Categories
Title
Measurements
BG000235.15± 86.117
BG001242.47± 79.864
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percent Change From Baseline in Fasting TG at Week 24
Full Analysis Set: All randomized participants who received at least 1 dose of investigational product (IP) during the study period, analyzed according to the treatment assigned at randomization.Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) at Day 1 and Week 12 injection during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG003
ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Units
Counts
Participants
OG00047
OG00147
OG00247
OG003
Title
Denominators
Categories
Title
Measurements
OG0007.55± 3.774
OG001-43.67± 3.770
OG002-49.01± 3.777
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening [≥100 mg/dL vs <100 mg/dL]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs. Placebo at Week 24
-51.22
2-Sided
95
-61.73
-40.70
ARO-ANG3 - Placebo
Superiority
Secondary
Percent Change From Baseline in Fasting TG Over Time
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, up to Week 36 (double-blind treatment period)
ID
Title
Description
OG000
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) at Day 1 and Week 12 injection during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG003
ARO-ANG3 200 mg
Secondary
Percent Change From Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization.Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) at Day 1 and Week 12 injection during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG003
ARO-ANG3 200 mg
Secondary
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, up to Week 36 (double-blind treatment period)
ID
Title
Description
OG000
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG003
ARO-ANG3 200 mg
Secondary
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization.Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG003
ARO-ANG3 200 mg
Secondary
Percent Change From Baseline in Fasting Total ApoB Over Time
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, up to Week 36 (double-blind treatment period)
ID
Title
Description
OG000
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) at Day 1 and Week 12 injection during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG003
ARO-ANG3 200 mg
Secondary
Percent Change From Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation at Week 24
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization.Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG003
ARO-ANG3 200 mg
Secondary
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, up to Week 36 (double-blind treatment period)
ID
Title
Description
OG000
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) at Day 1 and Week 12 injection during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG003
ARO-ANG3 200 mg
Secondary
Percent Change From Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 24
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization.Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG003
ARO-ANG3 200 mg
Secondary
Percent Change From Baseline in ANGPTL3 Over Time
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, up to Week 36 (double-blind treatment period)
ID
Title
Description
OG000
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) at Day 1 and Week 12 injection during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG003
ARO-ANG3 200 mg
Secondary
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization.Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG003
ARO-ANG3 200 mg
Secondary
Percent Change From Baseline in Fasting HDL-C Over Time
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, up to Week 36 (double-blind treatment period)
ID
Title
Description
OG000
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) at Day 1 and Week 12 injection during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG003
ARO-ANG3 200 mg
Secondary
Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period
Full PK Analysis Set: All participants who received at least 1 dose of active study drug and had at least 1 PK concentration data value. Observed cases.
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG001
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG002
ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and/or Serious TEAEs up to Week 24
TEAEs are adverse events (AEs) that occur following IP administration or a pre-existing condition exacerbated following IP administration. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
No
From first dose of IP up to Week 24
ID
Title
Description
OG000
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Secondary
Number of Participants With TEAEs and/or SAEs Over Time in the Double-Blind Treatment Period
Adverse event (AE)=any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. TEAEs=AEs with onset after administration of the study drug, or when a pre-existing medical condition increases in severity or frequency after study drug administration. Serious adverse event (SAE)= an AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction.
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
No
up to Week 36 (double-blind treatment period)
ID
Title
Description
OG000
Placebo (Pooled)
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Secondary
Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension (OLE) Period
Adverse event (AE)=any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. TEAEs=AEs with onset after administration of the study drug, or when a pre-existing medical condition increases in severity or frequency after study drug administration. Serious adverse event (SAE)= an AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction.
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
No
From first dose of study drug in the OLE up to Month 24 (open-label extension)
ID
Title
Description
OG000
Placebo/ARO-ANG3 50mg
Placebo calculated volume to match active treatment by subcutaneous (sc) injection for Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg/ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection for up to 8 doses during the open-label extension period.
Secondary
Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, OLE Baseline, Months 1-24 (open-label extension)
ID
Title
Description
OG000
ARO-ANG3 50 mg/ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
OG001
Placebo/ARO-ANG3 50 mg
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
OG002
Placebo/ARO-ANG3 100 mg
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
Secondary
Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, OLE Baseline, Months 1-24 (open-label extension)
ID
Title
Description
OG000
Placebo/ARO-ANG3 50 mg
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg/ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
OG002
Placebo/ARO-ANG3 100 mg
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
Secondary
Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, OLE Baseline, Months 1-24 (open-label extension)
ID
Title
Description
OG000
Placebo/ARO-ANG3 50 mg
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg/ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
OG002
Placebo/ARO-ANG3 100 mg
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
Secondary
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, OLE Baseline, Months 1-24 (open-label extension)
ID
Title
Description
OG000
Placebo/ARO-ANG3 50 mg
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg/ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
OG002
Placebo/ARO-ANG3 100 mg
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
Secondary
Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, OLE Baseline, Months 1-24 (open-label extension)
ID
Title
Description
OG000
Placebo/ARO-ANG3 50 mg
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg/ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
OG002
Placebo/ARO-ANG3 100 mg
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
Secondary
Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period
Full Analysis Set: All randomized participants who received at least 1 dose of IP during the study period, analyzed according to the treatment assigned at randomization. Observed cases.
Posted
Least Squares Mean
Standard Error
percentage change
Baseline, OLE Baseline, Months 1-24 (open-label extension)
ID
Title
Description
OG000
Placebo/ARO-ANG3 50 mg
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
OG001
ARO-ANG3 50 mg/ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
OG002
Placebo/ARO-ANG3 100 mg
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
Time Frame
All-cause mortality: From randomization through Month 24. Adverse events: From first dose of study drug through Week 36 (double-blind period); from first dose of open-label study drug up to Month 24 (open-label extension).
Description
Safety Analysis Set: All participants who received at least 1 dose of IP during the study period, analyzed according to the treatment they actually received.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period.
1
51
4
51
41
51
EG001
ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.
0
50
5
50
38
50
EG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.
0
51
0
51
41
51
EG003
ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period.
0
52
1
52
42
52
EG004
Placebo/ARO-ANG3 50 mg
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
0
13
3
13
10
13
EG005
ARO-ANG3 50 mg/ARO-ANG3 50 mg
ARO-ANG3 50 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 50 mg by sc injection during the open-label extension period.
0
36
4
36
31
36
EG006
Placebo/ARO-ANG3 100 mg
Placebo calculated volume to match active treatment by subcutaneous (sc) injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
0
14
2
14
14
14
EG007
ARO-ANG3 100 mg/ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
1
39
5
39
34
39
EG008
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
0
13
2
13
11
13
EG009
ARO-ANG3 200mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
0
41
5
41
34
41
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG0030 affected52 at risk
EG0040 affected13 at risk
EG0050 affected36 at risk
EG0060 affected14 at risk
EG0071 affected39 at risk
EG0080 affected13 at risk
EG0090 affected41 at risk
Angina unstable
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Bundle branch block left
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Silent myocardial infarction
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Incarcerated umbilical hernia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Death
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Diabetic ketosis
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Hyperglycaemic hyperosmolar nonketotic syndrome
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Chronic rhinosinusitis with nasal polyps
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG0033 affected52 at risk
EG0040 affected13 at risk
EG0051 affected36 at risk
EG0061 affected14 at risk
EG0070 affected39 at risk
EG0080 affected13 at risk
EG0093 affected41 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG003
Splenic cyst
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Aortic valve sclerosis
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Heart failure with reduced ejection fraction
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Hypertensive heart disease
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG003
Suprventricular tachycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Tricuspid valve incompetence
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Cataract
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Chalazion
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0022 affected51 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected50 at risk
EG0020 affected51 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected50 at risk
EG0022 affected51 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Acquired oesophageal web
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Barrett's oesophagus
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG003
Defaecation urgency
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected51 at risk
EG0012 affected50 at risk
EG0024 affected51 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected51 at risk
EG0012 affected50 at risk
EG0021 affected51 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0022 affected51 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0012 affected50 at risk
EG0020 affected51 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0013 affected50 at risk
EG0023 affected51 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Tooth impacted
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG003
Administration site reaction
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Asthenia
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Fatigue
General disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected51 at risk
EG0012 affected50 at risk
EG0022 affected51 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected51 at risk
EG0012 affected50 at risk
EG0023 affected51 at risk
EG003
Injection site bruising
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Injection site erythema
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0022 affected51 at risk
EG003
Injection site induration
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Injection site pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0015 affected50 at risk
EG0027 affected51 at risk
EG003
Injection site pruritus
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected50 at risk
EG0021 affected51 at risk
EG003
Malaise
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0013 affected50 at risk
EG0023 affected51 at risk
EG003
Peripheral swelling
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Hepatic cyst
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0022 affected51 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0013 affected50 at risk
EG0024 affected51 at risk
EG003
COVID-19
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG00014 affected51 at risk
EG00116 affected50 at risk
EG00216 affected51 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected50 at risk
EG0023 affected51 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0013 affected50 at risk
EG0020 affected51 at risk
EG003
Ear infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0004 affected51 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG003
Helicobacter gastritis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Infective exacerbation of asthma
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG003
Labyrinthitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0004 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected50 at risk
EG0021 affected51 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected50 at risk
EG0022 affected51 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG003
Pyuria
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0004 affected51 at risk
EG0013 affected50 at risk
EG0020 affected51 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected50 at risk
EG0020 affected51 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0022 affected51 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0007 affected51 at risk
EG0018 affected50 at risk
EG0029 affected51 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0005 affected51 at risk
EG0016 affected50 at risk
EG0026 affected51 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected50 at risk
EG0023 affected51 at risk
EG003
Wound infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0003 affected51 at risk
EG0012 affected50 at risk
EG0023 affected51 at risk
EG003
Ear canal injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0004 affected51 at risk
EG0012 affected50 at risk
EG0021 affected51 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0003 affected51 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG003
Musculoskeletal injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0022 affected51 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0003 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0022 affected51 at risk
EG003
Tendon injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Amylase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Bacterial test positive
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0003 affected51 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG003
Blood glucose increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Cardiac murmur
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0014 affected50 at risk
EG0023 affected51 at risk
EG003
High density lipoprotein decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Lipase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected50 at risk
EG0023 affected51 at risk
EG003
Low density lipoprotein increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Troponin increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Urine analysis abnormal
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
White blood cells urine positive
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected50 at risk
EG0020 affected51 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0005 affected51 at risk
EG0014 affected50 at risk
EG0022 affected51 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0004 affected51 at risk
EG0013 affected50 at risk
EG0024 affected51 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0015 affected50 at risk
EG0022 affected51 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Facet joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0022 affected51 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0005 affected51 at risk
EG0012 affected50 at risk
EG0020 affected51 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0013 affected50 at risk
EG0021 affected51 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0022 affected51 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected50 at risk
EG0023 affected51 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected50 at risk
EG0023 affected51 at risk
EG003
Vertebral foraminal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0012 affected50 at risk
EG0021 affected51 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Diabetic neuropathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected51 at risk
EG0013 affected50 at risk
EG0024 affected51 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0006 affected51 at risk
EG0016 affected50 at risk
EG0023 affected51 at risk
EG003
Hypokinesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected50 at risk
EG0020 affected51 at risk
EG003
Adjustment disorder
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0022 affected51 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected50 at risk
EG0022 affected51 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0020 affected51 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected51 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0022 affected51 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0010 affected50 at risk
EG0022 affected51 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0013 affected50 at risk
EG0020 affected51 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0013 affected50 at risk
EG0021 affected51 at risk
EG003
Obstructive sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0011 affected50 at risk
EG0022 affected51 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected50 at risk
EG0020 affected51 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0011 affected50 at risk
EG0021 affected51 at risk
EG003
Hand dermatitis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0022 affected51 at risk
EG003
Nail bed bleeding
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0010 affected50 at risk
EG0021 affected51 at risk
EG003
Skin haemorrhage
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Solar lentigo
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected51 at risk
EG0012 affected50 at risk
EG0020 affected51 at risk
EG003
Hot flush
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0012 affected50 at risk
EG0022 affected51 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected51 at risk
EG0010 affected50 at risk
EG0020 affected51 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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).
The adjusted p-value is calculated using the Holm method for multiplicity adjustment.
Superiority
OG000
OG002
Mixed Models Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening [≥100 mg/dL vs <100 mg/dL]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs Placebo at Week 24
-56.56
2-Sided
95
-67.09
-46.04
ARO-ANG3 - Placebo
Superiority
OG000
OG002
Holm method
<.0001
The adjusted p-value is calculated using the Holm method for multiplicity adjustment.
Superiority
OG000
OG003
Mixed Model with Repeated Measures
<.0001
Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening [≥100 mg/dL vs <100 mg/dL]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs. Placebo at Week 24
-63.11
2-Sided
95
-73.56
-52.66
Superiority
OG000
OG003
Holm method
<.0001
The adjusted p-value is calculated using the Holm method for multiplicity adjustment.
Superiority
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Units
Counts
Participants
OG00051
OG00151
OG00251
OG00351
Title
Denominators
Categories
Week 4
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00248
ParticipantsOG00350
Title
Measurements
OG0007.00± 3.583
OG001-41.52± 3.604
OG002-52.22± 3.658
OG003
Week 8
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00249
ParticipantsOG00349
Week 12
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00248
ParticipantsOG00351
Week 16
ParticipantsOG00049
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00351
Week 20
ParticipantsOG00048
ParticipantsOG00148
ParticipantsOG00248
ParticipantsOG00351
Week 24
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00247
ParticipantsOG00349
Week 28
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00245
ParticipantsOG00349
Week 36
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00246
ParticipantsOG00350
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 4
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-48.52
2-Sided
95
-58.53
-38.51
Superiority
OG000
OG002
Week 4
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-59.21
2-Sided
95
-69.30
-49.12
Superiority
OG000
OG003
Week 4
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-63.21
2-Sided
95
-73.24
-53.18
Superiority
OG000
OG001
Week 8
m
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-54.60
2-Sided
95
-66.31
-42.89
Superiority
OG000
OG002
Week 8
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-61.31
2-Sided
95
-73.07
-49.55
Superiority
OG000
OG003
Week 8
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-66.13
2-Sided
95
-77.90
-54.37
Superiority
OG000
OG001
Week 12
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-44.96
2-Sided
95
-56.91
-33.01
Superiority
OG000
OG002
Week 12
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-43.87
2-Sided
95
-55.83
-31.92
Superiority
OG000
OG003
Week 12
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-52.00
2-Sided
95
-63.83
-40.18
Superiority
OG000
OG001
Week 16
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-65.66
2-Sided
95
-85.04
-46.29
Superiority
OG000
OG002
Week 16
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-69.17
2-Sided
95
-88.54
-49.80
Superiority
OG000
OG003
Week 16
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-75.91
2-Sided
95
-95.11
-56.71
Superiority
OG000
OG001
Week 20
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-60.24
2-Sided
95
-76.78
-43.71
Superiority
OG000
OG002
Week 20
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-64.27
2-Sided
95
-80.83
-47.72
Superiority
OG000
OG003
Week 20
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-69.52
2-Sided
95
-85.85
-53.18
Superiority
OG000
OG001
Week 24
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-51.22
2-Sided
95
-61.73
-40.70
Superiority
OG000
OG002
Week 24
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-56.56
2-Sided
95
-67.09
-46.04
Superiority
OG000
OG003
Week 24
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-63.11
2-Sided
95
-73.56
-52.66
Superiority
OG000
OG001
Week 28
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-48.62
2-Sided
95
-59.66
-37.59
Superiority
OG000
OG002
Week 28
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-51.19
2-Sided
95
-62.32
-40.05
Superiority
OG000
OG003
Week 28
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-61.63
2-Sided
95
-72.60
-50.67
Superiority
OG000
OG001
Week 36
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-34.06
2-Sided
95
-44.65
-23.46
Superiority
OG000
OG002
Week 36
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-37.90
2-Sided
95
-48.56
-27.25
Superiority
OG000
OG003
Week 36
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-51.19
2-Sided
95
-61.71
-40.68
Superiority
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Units
Counts
Participants
OG00047
OG00147
OG00247
OG00349
Title
Denominators
Categories
Title
Measurements
OG0004.2± 3.31
OG001-25.1± 3.31
OG002-24.6± 3.31
OG003-32.2± 3.26
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Repeated Measures
<.0001
Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening [≥100 mg/dL vs <100 mg/dL]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs. Placebo at Week 24
-29.2
2-Sided
95
-38.5
-20.0
Superiority
OG000
OG002
Mixed Models Repeated Measures
<.0001
Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening [≥100 mg/dL vs <100 mg/dL]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs. Placebo at Week 24
-28.7
2-Sided
95
-37.9
-19.5
Superiority
OG000
OG003
Mixed Models Repeated Measures
<.0001
Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening [≥100 mg/dL vs <100 mg/dL]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs. Placebo at Week 24
-36.4
2-Sided
95
-45.5
-27.2
Superiority
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Units
Counts
Participants
OG00051
OG00151
OG00251
OG00351
Title
Denominators
Categories
Week 4
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00248
ParticipantsOG00350
Title
Measurements
OG0005.2± 2.51
OG001-23.5± 2.52
OG002-25.3± 2.55
OG003
Week 8
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00249
ParticipantsOG00349
Week 12
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00248
ParticipantsOG00351
Week 16
ParticipantsOG00049
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00351
Week 20
ParticipantsOG00048
ParticipantsOG00148
ParticipantsOG00248
ParticipantsOG00351
Week 24
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00247
ParticipantsOG00349
Week 28
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00245
ParticipantsOG00349
Week 36
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00246
ParticipantsOG00350
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 4
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-28.7
2-Sided
95
-35.7
-21.7
Superiority
OG000
OG002
Week 4
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-30.5
2-Sided
95
-37.5
-23.4
Superiority
OG000
OG003
Week 4
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-38.1
2-Sided
95
-45.1
-31.2
Superiority
OG000
OG001
Week 8
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-28.2
2-Sided
95
-36.6
-19.7
Superiority
OG000
OG002
Week 8
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-26.6
2-Sided
95
-35.0
-18.1
Superiority
OG000
OG003
Week 8
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-34.0
2-Sided
95
-42.4
-25.6
Superiority
OG000
OG001
Week 12
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-26.1
2-Sided
95
-34.6
-17.6
Superiority
OG000
OG002
Week 12
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-21.8
2-Sided
95
-30.3
-13.3
Superiority
OG000
OG003
Week 12
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-31.5
2-Sided
95
-39.9
-23.1
Superiority
OG000
OG001
Week 16
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-29.3
2-Sided
95
-37.3
-21.4
Superiority
OG000
OG002
Week 16
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-30.8
2-Sided
95
-38.8
-22.9
Superiority
OG000
OG003
Week 16
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-39.5
2-Sided
95
-47.4
-31.6
Other
OG000
OG001
Week 20
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-28.9
2-Sided
95
-36.4
-21.4
Superiority
OG000
OG002
Week 20
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-27.2
2-Sided
95
-34.8
-19.7
Superiority
OG000
OG003
Week 20
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-34.8
2-Sided
95
-42.3
-27.4
Superiority
OG000
OG001
Week 24
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-29.2
2-Sided
95
-38.5
-20.0
Superiority
OG000
OG002
Week 24
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-28.7
2-Sided
95
-37.9
-19.5
Superiority
OG000
OG003
Week 24
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-36.4
2-Sided
95
-45.5
-27.2
Superiority
OG000
OG001
Week 28
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-24.3
2-Sided
95
-32.7
-15.9
Superiority
OG000
OG002
Week 28
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-23.5
2-Sided
95
-31.9
-15.1
Superiority
OG000
OG003
Week 28
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-31.2
2-Sided
95
-39.5
-22.9
Superiority
OG000
OG001
Week 36
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-18.6
2-Sided
95
-27.6
-9.7
Superiority
OG000
OG002
Week 36
Mixed Model Repeated Measures (MMRM)
0.0006
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-15.8
2-Sided
95
-24.7
-6.8
Superiority
OG000
OG003
Week 36
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-22.6
2-Sided
95
-31.4
-13.8
Superiority
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Units
Counts
Participants
OG00046
OG00146
OG00246
OG00348
Title
Denominators
Categories
Title
Measurements
OG0002.27± 2.807
OG001-16.40± 2.835
OG002-12.91± 2.805
OG003-19.64± 2.788
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Repeated Measures
<.0001
Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening [≥100 mg/dL vs <100 mg/dL]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs. Placebo at Week 24
-18.66
2-Sided
95
-26.53
-10.80
Superiority
OG000
OG002
Mixed Models Repeated Measures
0.0002
Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening [≥100 mg/dL vs <100 mg/dL]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs. Placebo at Week 24
-15.18
2-Sided
95
-23.00
-7.36
Superiority
OG000
OG003
Mixed Models Repeated Measures
<.0001
Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening [≥100 mg/dL vs <100 mg/dL]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs. Placebo at Week 24
-21.90
2-Sided
95
-29.69
-14.12
Superiority
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Units
Counts
Participants
OG00051
OG00151
OG00251
OG00351
Title
Denominators
Categories
Week 4
ParticipantsOG00050
ParticipantsOG00150
ParticipantsOG00248
ParticipantsOG00349
Title
Measurements
OG0002.57± 2.074
OG001-14.00± 2.116
OG002-11.71± 2.093
OG003
Week 8
ParticipantsOG00050
ParticipantsOG00150
ParticipantsOG00249
ParticipantsOG00348
Week 12
ParticipantsOG00046
ParticipantsOG00148
ParticipantsOG00248
ParticipantsOG00350
Week 16
ParticipantsOG00048
ParticipantsOG00149
ParticipantsOG00248
ParticipantsOG00350
Week 20
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00248
ParticipantsOG00350
Week 24
ParticipantsOG00046
ParticipantsOG00146
ParticipantsOG00246
ParticipantsOG00348
Week 28
ParticipantsOG00047
ParticipantsOG00146
ParticipantsOG00245
ParticipantsOG00348
Week 36
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00246
ParticipantsOG00349
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 4
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-16.57
2-Sided
95
-22.41
-10.74
Superiority
OG000
OG002
Week 4
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-14.28
2-Sided
95
-20.08
-8.48
Superiority
OG000
OG003
Week 4
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-21.04
2-Sided
95
-26.85
-15.23
Superiority
OG000
OG001
Week 8
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-17.35
2-Sided
95
-24.42
-10.29
Superiority
OG000
OG002
Week 8
Mixed Model Repeated Measures (MMRM)
0.0008
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-12.16
2-Sided
95
-19.19
-5.13
Superiority
OG000
OG003
Week 8
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-16.56
2-Sided
95
-23.62
-9.50
Superiority
OG000
OG001
Week 12
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-17.21
2-Sided
95
-24.61
-9.81
Superiority
OG000
OG002
Week 12
Mixed Model Repeated Measures (MMRM)
0.0082
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-9.95
2-Sided
95
-17.30
-2.60
Superiority
OG000
OG003
Week 12
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-17.35
2-Sided
95
-24.68
-10.03
Superiority
OG000
OG001
Week 16
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-14.36
2-Sided
95
-21.42
-7.30
Superiority
OG000
OG002
Week 16
Mixed Model Repeated Measures (MMRM)
0.0003
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-12.97
2-Sided
95
-19.98
-5.95
Superiority
OG000
OG003
Week 16
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-20.30
2-Sided
95
-27.30
-13.29
Other
OG000
OG001
Week 20
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-17.71
2-Sided
95
-24.29
-11.13
Superiority
OG000
OG002
Week 20
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-14.23
2-Sided
95
-20.75
-7.72
Superiority
OG000
OG003
Week 20
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-18.30
2-Sided
95
-24.80
-11.79
Superiority
OG000
OG001
Week 24
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-18.66
2-Sided
95
-26.53
-10.80
Superiority
OG000
OG002
Week 24
Mixed Model Repeated Measures (MMRM)
0.0002
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-15.18
2-Sided
95
-23.00
-7.36
Superiority
OG000
OG003
Week 24
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-21.90
2-Sided
95
-29.69
-14.12
Superiority
OG000
OG001
Week 28
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-15.90
2-Sided
95
-23.44
-8.35
Superiority
OG000
OG002
Week 28
Mixed Model Repeated Measures (MMRM)
0.0008
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-12.98
2-Sided
95
-20.49
-5.46
Superiority
OG000
OG003
Week 28
Mixed Model Repeated Measures (MMRM)
<.0001
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-17.54
2-Sided
95
-25.01
-10.07
Superiority
OG000
OG001
Week 36
Mixed Model Repeated Measures (MMRM)
0.0081
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-10.55
2-Sided
95
-18.32
-2.77
Superiority
OG000
OG002
Week 36
Mixed Model Repeated Measures (MMRM)
0.0871
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-6.76
2-Sided
95
-14.52
0.99
Superiority
OG000
OG003
Week 36
Mixed Model Repeated Measures (MMRM)
0.0058
MMRM model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms, and treatment by visit and treatment by baseline as interaction terms.
Difference
-10.91
2-Sided
95
-18.61
-3.20
Superiority
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Units
Counts
Participants
OG00047
OG00147
OG00247
OG00349
Title
Denominators
Categories
Title
Measurements
OG0005.0± 4.53
OG001-11.0± 4.58
OG002-4.3± 4.56
OG003-15.1± 4.51
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Repeated Measures
0.0138
Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs. Placebo at Week 24
-16.0
2-Sided
95
-28.7
-3.3
Superiority
OG000
OG002
Mixed Models Repated Measures
0.1480
Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs Placebo at Week 24
-9.3
2-Sided
95
-22.0
3.3
Superiority
OG000
OG003
Mxed Models Repeated Measures
0.0019
Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs Placebo at Week 24
-20.2
2-Sided
95
-32.8
-7.5
Superiority
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Units
Counts
Participants
OG00051
OG00151
OG00251
OG00351
Title
Denominators
Categories
Week 4
ParticipantsOG00051
ParticipantsOG00149
ParticipantsOG00248
ParticipantsOG00350
Title
Measurements
OG0005.1± 3.95
OG001-8.3± 4.03
OG002-3.4± 4.02
OG003
Week 8
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00249
ParticipantsOG00349
Week 12
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00248
ParticipantsOG00351
Week 16
ParticipantsOG00049
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00351
Week 20
ParticipantsOG00048
ParticipantsOG00148
ParticipantsOG00248
ParticipantsOG00351
Week 24
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00247
ParticipantsOG00349
Week 28
ParticipantsOG00048
ParticipantsOG00146
ParticipantsOG00245
ParticipantsOG00349
Week 36
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00246
ParticipantsOG00350
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 4
Mixed Model Repeated Measures (MMRM)
0.0192
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-13.3
2-Sided
95
-24.5
-2.2
Superiority
OG000
OG002
Week 4
Mixed Model Repeated Measures (MMRM)
0.1362
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-8.4
2-Sided
95
-19.6
2.7
Superiority
OG000
OG003
Week 4
Mixed Model Repeated Measures (MMRM)
0.0010
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-18.7
2-Sided
95
-29.8
-7.7
Superiority
OG000
OG001
Week 8
Mixed Model Repeated Measures (MMRM)
0.0428
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-13.9
2-Sided
95
-27.3
-0.5
Superiority
OG000
OG002
Week 8
Mixed Model Repeated Measures (MMRM)
0.5122
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-4.5
2-Sided
95
-17.9
8.9
Superiority
OG000
OG003
Week 8
Mixed Model Repeated Measures (MMRM)
0.0331
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-14.6
2-Sided
95
-27.9
-1.2
Superiority
OG000
OG001
Week 12
Mixed Model Repeated Measures (MMRM)
0.1400
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-15.4
2-Sided
95
-35.8
5.1
Superiority
OG000
OG002
Week 12
Mixed Model Repeated Measures (MMRM)
0.9854
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
0.2
2-Sided
95
-20.2
20.6
Superiority
OG000
OG003
Week 12
Mixed Model Repeated Measures (MMRM)
0.0552
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-19.8
2-Sided
95
-40.1
0.4
Superiority
OG000
OG001
Week 16
Mixed Model Repeated Measures (MMRM)
0.0430
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-13.1
2-Sided
95
-25.7
-0.4
Superiority
OG000
OG002
Week 16
Mixed Model Repeated Measures (MMRM)
0.0871
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-11.0
2-Sided
95
-23.6
1.6
Superiority
OG000
OG003
Week 16
Mixed Model Repeated Measures (MMRM)
0.0004
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-23.1
2-Sided
95
-35.7
-10.6
Superiority
OG000
OG001
Week 20
Mixed Model Repeated Measures (MMRM)
0.0219
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-14.0
2-Sided
95
-25.9
-2.0
Superiority
OG000
OG002
Week 20
Mixed Model Repeated Measures (MMRM)
0.1526
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-8.7
2-Sided
95
-20.6
3.2
Superiority
OG000
OG003
Week 20
Mixed Model Repeated Measures (MMRM)
0.0049
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-17.0
2-Sided
95
-28.9
-5.2
Superiority
OG000
OG001
Week 24
Mixed Model Repeated Measures (MMRM)
0.0138
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-16.0
2-Sided
95
-28.7
-3.3
Superiority
OG000
OG002
Week 24
Mixed Model Repeated Measures (MMRM)
0.1480
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-9.3
2-Sided
95
-22.0
3.3
Superiority
OG000
OG003
Week 24
Mixed Model Repeated Measures (MMRM)
0.0019
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-20.2
2-Sided
95
-32.8
-7.5
Superiority
OG000
OG001
Week 28
Mixed Model Repeated Measures (MMRM)
0.1660
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-9.3
2-Sided
95
-22.4
3.9
Superiority
OG000
OG002
Week 28
Mixed Model Repeated Measures (MMRM)
0.6964
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-2.6
2-Sided
95
-15.7
10.5
Superiority
OG000
OG003
Week 28
Mixed Model Repeated Measures (MMRM)
0.0831
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-11.5
2-Sided
95
-24.5
1.5
Superiority
OG000
OG001
Week 36
Mixed Model Repeated Measures (MMRM)
0.1425
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-12.0
2-Sided
95
-28.2
4.1
Superiority
OG000
OG002
Week 36
Mixed Model Repeated Measures (MMRM)
0.9494
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
0.5
2-Sided
95
-15.6
16.6
Superiority
OG000
OG003
Week 36
Mixed Model Repeated Measures (MMRM)
0.3535
MMRM model includes treatment arm, study visit, and baseline value as model terms. The model also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-7.5
2-Sided
95
-23.5
8.4
Superiority
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Units
Counts
Participants
OG00047
OG00146
OG00247
OG00349
Title
Denominators
Categories
Title
Measurements
OG0001.24± 2.801
OG001-53.02± 2.829
OG002-68.52± 2.807
OG003-72.45± 2.761
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
mixed Models Repeated Measures
<.0001
Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening [≥100 mg/dL vs <100 mg/dL]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs Placebo
-54.26
2-Sided
95
-62.11
-46.40
Superiority
OG000
OG002
Mixed Models Repeated Measures
<.0001
Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening [≥100 mg/dL vs <100 mg/dL]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs Placebo at Week 24
-69.76
2-Sided
95
-77.58
-61.95
Superiority
OG000
OG003
Mixed Models Repeated Measures
<.0001
Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening [≥100 mg/dL vs <100 mg/dL]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs Placebo at Week 24
-73.69
2-Sided
95
-81.44
-65.93
Superiority
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Units
Counts
Participants
OG00051
OG00151
OG00251
OG00351
Title
Denominators
Categories
Week 4
ParticipantsOG00051
ParticipantsOG00149
ParticipantsOG00248
ParticipantsOG00350
Title
Measurements
OG0005.54± 2.353
OG001-62.11± 2.388
OG002-75.25± 2.401
OG003
Week 8
ParticipantsOG00051
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00349
Week 12
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00248
ParticipantsOG00351
Week 16
ParticipantsOG00049
ParticipantsOG00148
ParticipantsOG00249
ParticipantsOG00351
Week 20
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00248
ParticipantsOG00351
Week 24
ParticipantsOG00047
ParticipantsOG00146
ParticipantsOG00247
ParticipantsOG00349
Week 28
ParticipantsOG00048
ParticipantsOG00146
ParticipantsOG00245
ParticipantsOG00349
Week 36
ParticipantsOG00048
ParticipantsOG00146
ParticipantsOG00246
ParticipantsOG00350
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 4
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-67.65
2-Sided
95
-74.26
-61.04
Superiority
OG000
OG002
Week 4
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-80.80
2-Sided
95
-87.42
-74.17
Superiority
OG000
OG003
Week 4
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-84.69
2-Sided
95
-91.27
-78.12
Superiority
OG000
OG001
Week 8
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-59.07
2-Sided
95
-67.57
-50.57
Superiority
OG000
OG002
Week 8
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-71.98
2-Sided
95
-80.47
-63.50
Superiority
OG000
OG003
Week 8
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-76.44
2-Sided
95
-84.90
-67.99
Superiority
OG000
OG001
Week 12
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-55.10
2-Sided
95
-65.18
-45.01
Superiority
OG000
OG002
Week 12
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-70.55
2-Sided
95
-80.60
-60.51
Superiority
OG000
OG003
Week 12
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-74.00
2-Sided
95
-83.95
-64.04
Superiority
OG000
OG002
Week 16
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-72.22
2-Sided
95
-78.88
-65.56
Superiority
OG000
OG002
Week 16
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-84.09
2-Sided
95
-90.72
-77.46
Superiority
OG000
OG003
Week 16
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-89.00
2-Sided
95
-95.59
-82.42
Superiority
OG000
OG001
Week 20
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-64.86
2-Sided
95
-71.40
-58.31
Superiority
OG000
OG002
Week 20
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-77.45
2-Sided
95
-83.98
-70.93
Superiority
OG000
OG003
Week 20
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-80.60
2-Sided
95
-87.06
-74.14
Superiority
OG000
OG001
Week 24
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-54.26
2-Sided
95
-62.11
-46.40
Superiority
OG000
OG002
Week 24
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-69.76
2-Sided
95
-77.58
-61.95
Superiority
OG000
OG003
Week 24
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-73.69
2-Sided
95
-81.44
-65.93
Superiority
OG000
OG001
Week 28
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-54.75
2-Sided
95
-62.84
-46.67
Superiority
OG000
OG002
Week 28
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-66.60
2-Sided
95
-74.69
-58.52
Superiority
OG000
OG003
Week 28
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-73.37
2-Sided
95
-81.36
-65.38
Superiority
OG000
OG001
Week 36
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-45.43
2-Sided
95
-54.17
-36.69
Superiority
OG000
OG002
Week 36
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-57.15
2-Sided
95
-65.88
-48.41
Superiority
OG000
OG003
Week 36
Mixed Model Repeated Measures (MMRM)
<.0001
Model includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Includes treatment by visit and treatment by baseline as interaction terms.
Difference
-63.58
2-Sided
95
-72.19
-54.97
Superiority
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Units
Counts
Participants
OG00047
OG00147
OG00247
OG00349
Title
Denominators
Categories
Title
Measurements
OG0003.1± 2.91
OG001-9.0± 2.94
OG002-18.5± 2.96
OG003-21.5± 2.89
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Repeated Measures
0.0039
Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening [≥100 mg/dL vs <100 mg/dL]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs Placebo at Week 24
-12.0
2-Sided
95
-20.2
-3.9
Superiority
OG000
OG002
Mixed Models Repeated Measures
<.0001
Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening [≥100 mg/dL vs <100 mg/dL]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Difference vs Placebo at Week 24
-21.6
2-Sided
95
-29.8
-13.4
Superiority
OG000
OG003
Mixed Models Repeated Measures
<.0001
Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening [≥100 mg/dL vs <100 mg/dL]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.
Differeence vs Placebo at week 24
-24.5
2-Sided
95
-32.6
-16.5
Superiority
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Units
Counts
Participants
OG00051
OG00151
OG00251
OG00351
Title
Denominators
Categories
Week 4
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00248
ParticipantsOG00350
Title
Measurements
OG000-0.3± 2.59
OG001-13.9± 2.63
OG002-25.5± 2.68
OG003
Week 8
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00249
ParticipantsOG00349
Week 12
ParticipantsOG00047
ParticipantsOG00148
ParticipantsOG00248
ParticipantsOG00351
Week 16
ParticipantsOG00049
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00351
Week 20
ParticipantsOG00048
ParticipantsOG00148
ParticipantsOG00248
ParticipantsOG00351
Week 24
ParticipantsOG00047
ParticipantsOG00147
ParticipantsOG00247
ParticipantsOG00349
Week 28
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00245
ParticipantsOG00349
Week 36
ParticipantsOG00048
ParticipantsOG00147
ParticipantsOG00246
ParticipantsOG00350
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 4
Mixed Model Repeated Measures (MMRM)
0.0003
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-13.7
2-Sided
95
-20.9
-6.4
Superiority
OG000
OG002
Week 4
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-25.3
2-Sided
95
-32.6
-17.9
Superiority
OG000
OG003
Week 4
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-24.5
2-Sided
95
-31.8
-17.3
Superiority
OG000
OG001
Week 8
Mixed Model Repeated Measures (MMRM)
0.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-15.0
2-Sided
95
-22.4
-7.5
Superiority
OG000
OG002
Week 8
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-25.4
2-Sided
95
-33.0
-17.9
Superiority
OG000
OG003
Week 8
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-26.2
2-Sided
95
-33.7
-18.7
Superiority
OG000
OG001
Week 12
Mixed Model Repeated Measures (MMRM)
0.0429
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-8.9
2-Sided
95
-17.6
-0.3
Superiority
OG000
OG002
Week 12
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-20.7
2-Sided
95
-29.4
-12.0
Superiority
OG000
OG003
Week 12
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-20.1
2-Sided
95
-28.7
-11.6
Superiority
OG000
OG001
Week 16
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-17.9
2-Sided
95
-26.2
-9.5
Superiority
OG000
OG002
Week 16
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-30.6
2-Sided
95
-39.0
-22.2
Superiority
OG000
OG003
Week 16
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-32.3
2-Sided
95
-40.5
-24.0
Superiority
OG000
OG001
Week 20
Mixed Model Repeated Measures (MMRM)
0.0005
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-14.6
2-Sided
95
-22.7
-6.5
Superiority
OG000
OG002
Week 20
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-28.4
2-Sided
95
-36.6
-20.3
Other
OG000
OG003
Week 20
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-30.4
2-Sided
95
-38.4
-22.4
Superiority
OG000
OG001
Week 24
Mixed Model Repeated Measures (MMRM)
0.0039
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-12.0
2-Sided
95
-20.2
-3.9
Superiority
OG000
OG002
Week 24
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-21.6
2-Sided
95
-29.8
-13.4
Superiority
OG000
OG003
Week 24
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-24.5
2-Sided
95
-32.6
-16.5
Superiority
OG000
OG001
Week 28
Mixed Model Repeated Measures (MMRM)
0.0343
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-8.4
2-Sided
95
-16.2
-0.6
Superiority
OG000
OG002
Week 28
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-17.7
2-Sided
95
-25.6
-9.8
Superiority
OG000
OG003
Week 28
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-21.5
2-Sided
95
-29.3
-13.8
Superiority
OG000
OG001
Week 36
Mixed Model Repeated Measures (MMRM)
0.0501
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-7.8
2-Sided
95
-15.6
0.0
Superiority
OG000
OG002
Week 36
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-20.1
2-Sided
95
-27.9
-12.2
Superiority
OG000
OG003
Week 36
Mixed Model Repeated Measures (MMRM)
<.0001
Includes treatment arm, study visit, randomization stratification factor (level of LDL-C at Screening [≥100 mg/dL versus <100 mg/dL]),and baseline value as model terms. Also includes treatment by visit and treatment by baseline as interaction terms.
Difference
-15.8
2-Sided
95
-23.5
-8.1
Superiority
Units
Counts
Participants
OG00016
OG00121
OG00218
Title
Denominators
Categories
Day 1, Pre-Dose
ParticipantsOG00016
ParticipantsOG00121
ParticipantsOG00218
Title
Measurements
OG0000.0000± 0.00000
OG0012.6685± 12.22871
OG0020.0000± 0.00000
Day 1, 15 Minutes Post-Dose
ParticipantsOG00016
ParticipantsOG00121
ParticipantsOG00218
Title
Measurements
OG000
Day 1, 1 Hour Post-Dose
ParticipantsOG00016
ParticipantsOG00121
ParticipantsOG00218
Title
Measurements
OG000
Day 1, 3 Hours Post-Dose
ParticipantsOG00016
ParticipantsOG00121
ParticipantsOG00218
Title
Measurements
OG000
Day 1, 6 Hours Post-Dose
ParticipantsOG00016
ParticipantsOG00121
ParticipantsOG00218
Title
Measurements
OG000
Day 2, 24 Hours Post-Dose
ParticipantsOG00016
ParticipantsOG00120
ParticipantsOG00217
Title
Measurements
OG000
Week 12, Pre-Dose
ParticipantsOG00014
ParticipantsOG00118
ParticipantsOG00216
Title
Measurements
OG000
Week 12, 15 Minutes Post-Dose
ParticipantsOG00014
ParticipantsOG00118
ParticipantsOG00216
Title
Measurements
OG000
Week 12, 1 Hour Post-Dose
ParticipantsOG00014
ParticipantsOG00118
ParticipantsOG00216
Title
Measurements
OG000
Week 12, 3 Hours Post-Dose
ParticipantsOG00014
ParticipantsOG00118
ParticipantsOG00216
Title
Measurements
OG000
Week 12, 6 Hours Post-Dose
ParticipantsOG00014
ParticipantsOG00118
ParticipantsOG00216
Title
Measurements
OG000
Week 12, 24 Hours Post-Dose
ParticipantsOG00014
ParticipantsOG00118
ParticipantsOG00216
Title
Measurements
OG000
OG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG003
ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Units
Counts
Participants
OG00051
OG00150
OG00251
OG00352
Title
Denominators
Categories
All TEAEs (Including Serious)
Title
Measurements
OG00030
OG00137
OG00229
OG00339
Serious TEAEs
Title
Measurements
OG0003
OG0013
OG0020
OG003
OG002
ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
OG003
ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
Units
Counts
Participants
OG00051
OG00150
OG00251
OG00352
Title
Denominators
Categories
All Treatment-Emergent Adverse Events (TEAEs)
Title
Measurements
OG00035
OG00140
OG00234
OG00342
Treatment-related TEAEs
Title
Measurements
OG0008
OG00112
OG0028
OG003
Serious TEAEs
Title
Measurements
OG0004
OG0015
OG0020
OG003
TEAEs leading to study drug discontinuation
Title
Measurements
OG0002
OG0010
OG0021
OG003
Deaths
Title
Measurements
OG0001
OG0010
OG0020
OG003
Local Injection Site Reactions (LISR)
Title
Measurements
OG0001
OG0010
OG0023
OG003
OG002
Placebo/ARO-ANG3 100 mg
Placebo calculated volume to match active treatment ARO-ANG3 100 mg by sc injection for up to 8 doses during the open-label extension period.
OG003
ARO-ANG3 100 mg/ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection for up to 8 doses during the open-label extension period.
OG004
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
OG005
ARO-ANG3 200 mg/ARO-ANG3 200 mg
ARO-ANG3 200 mg by sc injection for up to 8 doses during the open-label extension period.
Units
Counts
Participants
OG00013
OG00136
OG00214
OG00339
OG00413
OG00541
Title
Denominators
Categories
All Treatment-Emergent Adverse Events (TEAEs)
Title
Measurements
OG00010
OG00127
OG00213
OG00330
OG00410
OG00531
Treatment-related TEAEs
Title
Measurements
OG0002
OG0018
OG0024
OG003
Serious TEAEs
Title
Measurements
OG0003
OG0014
OG0022
OG003
TEAEs leading to study drug discontinuation
Title
Measurements
OG0000
OG0010
OG0021
OG003
Deaths
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
ARO-ANG3 100 mg/ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
OG004
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
OG005
ARO-ANG3 200mg/ARO-ANG3 200mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
Units
Counts
Participants
OG00013
OG00136
OG00214
OG00339
OG00413
OG00541
Title
Denominators
Categories
Percent Change from Baseline to OLE Baseline/OLE Day 1
ParticipantsOG00013
ParticipantsOG00136
ParticipantsOG00214
ParticipantsOG00339
ParticipantsOG00413
ParticipantsOG00541
Title
Measurements
OG000-10.02± 8.711
OG001-34.78± 3.941
OG002-2.09± 13.925
OG003
Percent Change from Baseline to OLE Month 1
ParticipantsOG00013
ParticipantsOG00135
ParticipantsOG00214
ParticipantsOG00339
Percent Change from Baseline to OLE Month 2
ParticipantsOG00013
ParticipantsOG00136
ParticipantsOG00214
ParticipantsOG00339
Percent Change from Baseline to OLE Month 3
ParticipantsOG00013
ParticipantsOG00136
ParticipantsOG00214
ParticipantsOG00338
Percent Change from Baseline to OLE Month 6
ParticipantsOG00013
ParticipantsOG00136
ParticipantsOG00214
ParticipantsOG00335
Percent Change from Baseline to OLE Month 12
ParticipantsOG00012
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00335
Percent Change from Baseline to OLE Month 15
ParticipantsOG00012
ParticipantsOG00135
ParticipantsOG00211
ParticipantsOG00335
Percent Change from Baseline to OLE Month 18
ParticipantsOG00012
ParticipantsOG00135
ParticipantsOG00211
ParticipantsOG00335
Percent Change from Baseline to OLE Month 21
ParticipantsOG00011
ParticipantsOG00135
ParticipantsOG00210
ParticipantsOG00335
Percent Change from Baseline to OLE Month 24
ParticipantsOG0005
ParticipantsOG00120
ParticipantsOG0024
ParticipantsOG00320
OG003
ARO-ANG3 100 mg/ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
OG004
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
OG005
ARO-ANG3 200mg/ARO-ANG3 200mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
Units
Counts
Participants
OG00013
OG00136
OG00214
OG00339
OG00413
OG00541
Title
Denominators
Categories
Percent Change from Baseline to OLE Baseline/OLE Day 1
ParticipantsOG00013
ParticipantsOG00136
ParticipantsOG00214
ParticipantsOG00339
ParticipantsOG00413
ParticipantsOG00541
Title
Measurements
OG0006.70± 13.049
OG001-19.95± 3.532
OG002-5.02± 5.171
OG003
Percent Change from Baseline to OLE Month 1
ParticipantsOG00013
ParticipantsOG00135
ParticipantsOG00214
ParticipantsOG00339
Percent Change from Baseline to OLE Month 2
ParticipantsOG00013
ParticipantsOG00136
ParticipantsOG00214
ParticipantsOG00339
Percent Change from Baseline to OLE Month 3
ParticipantsOG00013
ParticipantsOG00136
ParticipantsOG00214
ParticipantsOG00338
Percent Change from Baseline to OLE Month 6
ParticipantsOG00013
ParticipantsOG00136
ParticipantsOG00214
ParticipantsOG00335
Percent Change from Baseline to OLE Month 12
ParticipantsOG00012
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00335
Percent Change from Baseline to OLE Month 15
ParticipantsOG00012
ParticipantsOG00135
ParticipantsOG00211
ParticipantsOG00335
Percent Change from Baseline to OLE Month 18
ParticipantsOG00012
ParticipantsOG00135
ParticipantsOG00211
ParticipantsOG00335
Percent Change from Baseline to OLE Month 21
ParticipantsOG00011
ParticipantsOG00135
ParticipantsOG00210
ParticipantsOG00335
Percent Change from Baseline to OLE Month 24
ParticipantsOG0005
ParticipantsOG00120
ParticipantsOG0024
ParticipantsOG00320
OG003
ARO-ANG3 100 mg/ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
OG004
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
OG005
ARO-ANG3 200mg/ARO-ANG3 200mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
Units
Counts
Participants
OG00013
OG00136
OG00214
OG00339
OG00413
OG00541
Title
Denominators
Categories
Percent Change from Baseline to OLE Baseline/OLE Day 1
ParticipantsOG00012
ParticipantsOG00136
ParticipantsOG00214
ParticipantsOG00339
ParticipantsOG00413
ParticipantsOG00540
Title
Measurements
OG0006.57± 8.959
OG001-13.49± 3.086
OG002-10.22± 4.678
OG003
Percent Change from Baseline to OLE Month 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
Percent Change from Baseline to OLE Month 2
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG0036
Percent Change from Baseline to OLE Month 3
ParticipantsOG0005
ParticipantsOG00113
ParticipantsOG0023
ParticipantsOG00312
Percent Change from Baseline to OLE Month 6
ParticipantsOG00010
ParticipantsOG00128
ParticipantsOG00211
ParticipantsOG00329
Percent Change from Baseline to OLE Month 12
ParticipantsOG00011
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00335
Percent Change from Baseline to OLE Month 15
ParticipantsOG00011
ParticipantsOG00135
ParticipantsOG00211
ParticipantsOG00335
Percent Change from Baseline to OLE Month 18
ParticipantsOG00011
ParticipantsOG00135
ParticipantsOG00211
ParticipantsOG00335
Percent Change from Baseline to OLE Month 21
ParticipantsOG00010
ParticipantsOG00135
ParticipantsOG00210
ParticipantsOG00335
Percent Change from Baseline to OLE Month 24
ParticipantsOG0004
ParticipantsOG00120
ParticipantsOG0024
ParticipantsOG00320
OG003
ARO-ANG3 100 mg/ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
OG004
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
OG005
ARO-ANG3 200mg/ARO-ANG3 200mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
Units
Counts
Participants
OG00013
OG00136
OG00214
OG00339
OG00413
OG00541
Title
Denominators
Categories
Percent Change from Baseline to OLE Baseline/OLE Day 1
ParticipantsOG00013
ParticipantsOG00136
ParticipantsOG00214
ParticipantsOG00339
ParticipantsOG00413
ParticipantsOG00541
Title
Measurements
OG00016.61± 13.866
OG001-7.68± 4.934
OG002-1.59± 8.079
OG003
Percent Change from Baseline to OLE Month 1
ParticipantsOG00013
ParticipantsOG00135
ParticipantsOG00214
ParticipantsOG00339
Percent Change from Baseline to OLE Month 2
ParticipantsOG00013
ParticipantsOG00136
ParticipantsOG00214
ParticipantsOG00339
Percent Change from Baseline to OLE Month 3
ParticipantsOG00013
ParticipantsOG00136
ParticipantsOG00214
ParticipantsOG00338
Percent Change from Baseline to OLE Month 6
ParticipantsOG00013
ParticipantsOG00136
ParticipantsOG00214
ParticipantsOG00335
Percent Change from Baseline to OLE Month 12
ParticipantsOG00012
ParticipantsOG00134
ParticipantsOG00212
ParticipantsOG00335
Percent Change from Baseline to OLE Month 15
ParticipantsOG00012
ParticipantsOG00135
ParticipantsOG00211
ParticipantsOG00335
Percent Change from Baseline to OLE Month 18
ParticipantsOG00012
ParticipantsOG00135
ParticipantsOG00211
ParticipantsOG00335
Percent Change from Baseline to OLE Month 21
ParticipantsOG00011
ParticipantsOG00135
ParticipantsOG00210
ParticipantsOG00335
Percent Change from Baseline to OLE Month 24
ParticipantsOG0005
ParticipantsOG00120
ParticipantsOG0024
ParticipantsOG00320
OG003
ARO-ANG3 100 mg/ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
OG004
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
OG005
ARO-ANG3 200mg/ARO-ANG3 200mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
Units
Counts
Participants
OG00013
OG00136
OG00214
OG00339
OG00413
OG00541
Title
Denominators
Categories
Percent Change from Baseline to OLE Baseline/OLE Day 1
ParticipantsOG00013
ParticipantsOG00135
ParticipantsOG00214
ParticipantsOG00339
ParticipantsOG00413
ParticipantsOG00541
Title
Measurements
OG0003.41± 5.372
OG001-41.57± 4.417
OG0024.47± 7.595
OG003
Percent Change from Baseline to OLE Month 1
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00214
ParticipantsOG00338
Percent Change from Baseline to OLE Month 2
ParticipantsOG00013
ParticipantsOG00135
ParticipantsOG00214
ParticipantsOG00339
Percent Change from Baseline to OLE Month 3
ParticipantsOG00013
ParticipantsOG00135
ParticipantsOG00214
ParticipantsOG00338
Percent Change from Baseline to OLE Month 6
ParticipantsOG00012
ParticipantsOG00134
ParticipantsOG00214
ParticipantsOG00335
Percent Change from Baseline to OLE Month 12
ParticipantsOG00012
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00335
Percent Change from Baseline to OLE Month 15
ParticipantsOG00012
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00335
Percent Change from Baseline to OLE Month 18
ParticipantsOG00012
ParticipantsOG00134
ParticipantsOG00211
ParticipantsOG00335
Percent Change from Baseline to OLE Month 21
ParticipantsOG00011
ParticipantsOG00134
ParticipantsOG00210
ParticipantsOG00335
Percent Change from Baseline to OLE Month 24
ParticipantsOG0005
ParticipantsOG00120
ParticipantsOG0024
ParticipantsOG00320
OG003
ARO-ANG3 100 mg/ARO-ANG3 100 mg
ARO-ANG3 100 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 100 mg by sc injection during the open-label extension period.
OG004
Placebo/ARO-ANG3 200 mg
Placebo calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
OG005
ARO-ANG3 200mg/ARO-ANG3 200mg
ARO-ANG3 200 mg by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 200 mg by sc injection during the open-label extension period.
Units
Counts
Participants
OG00013
OG00136
OG00214
OG00339
OG00413
OG00541
Title
Denominators
Categories
Percent Change from Baseline to OLE Baseline/OLE Day 1