Olpasiran Trials of Cardiovascular Events And LipoproteiN... | NCT04270760 | Trialant
NCT04270760
Sponsor
Amgen
Status
Completed
Last Update Posted
Mar 31, 2026Actual
Enrollment
281Actual
Phase
Phase 2
Conditions
Cardiovascular Disease
Interventions
Olpasiran
Placebo
Countries
United States
Australia
Canada
Denmark
Iceland
Japan
Netherlands
Protocol Section
Identification Module
NCT ID
NCT04270760
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
20180109
Secondary IDs
ID
Type
Description
Link
2019-003688-23
EudraCT Number
Brief Title
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
Official Title
A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Olpasiran (AMG 890) in Subjects With Elevated Lipoprotein(a)
Acronym
Not provided
Organization
AmgenINDUSTRY
Status Module
Record Verification Date
Mar 2026
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
Jul 28, 2020Actual
Primary Completion Date
Dec 27, 2021Actual
Completion Date
Nov 8, 2022Actual
First Submitted Date
Feb 13, 2020
First Submission Date that Met QC Criteria
Feb 13, 2020
First Posted Date
Feb 17, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Aug 1, 2023
Results First Submitted that Met QC Criteria
Aug 1, 2023
Results First Posted Date
Aug 23, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Oct 20, 2022
Certification/Extension First Submitted that Passed QC Review
Oct 20, 2022
Certification/Extension First Posted Date
Oct 24, 2022Actual
Last Update Submitted Date
Mar 18, 2026
Last Update Posted Date
Mar 31, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AmgenINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]).
Detailed Description
Not provided
Conditions Module
Conditions
Cardiovascular Disease
Keywords
Olpasiran
AMG 890
siRNA
lipoprotein (a) Lp(a)
Cardiovascular
Cardiovascular disease
Atherosclerotic cardiovascular disease
Cholesterol
Apolipoprotein (B)
Hyperlipidemia
Dyslipidemia
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
281Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm 1 Olpasiran Dose 1
Active Comparator
Drug: Olpasiran
Arm 2 Olpasiran Dose 2
Active Comparator
Drug: Olpasiran
Arm 3 Olpasiran Dose 3
Active Comparator
Drug: Olpasiran
Arm 4 Olpasiran Dose 4
Active Comparator
Drug: Olpasiran
Arm 5 Placebo Dose 5
Placebo Comparator
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Olpasiran
Drug
Dose 1 Dose 2 Dose 3 Dose 4
Arm 1 Olpasiran Dose 1
Arm 2 Olpasiran Dose 2
Arm 3 Olpasiran Dose 3
Arm 4 Olpasiran Dose 4
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Baseline and Week 36
Secondary Outcomes
Measure
Description
Time Frame
Percentage Change From Baseline in Lp(a) at Week 48
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Baseline and Week 48
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 36 and Week 48
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Age 18 to 80 years
Lipoprotein (a) > 150 nmol/L
Evidence of atherosclerotic cardiovascular disease
Exclusion Criteria:
Severe renal dysfunction
History or clinical evidence of hepatic dysfunction
Malignancy within the last 5 years
Currently receiving, or less than 3 months at Day 1 since receiving > 200 mg/day Niacin
O'Donoghue ML, G Lopez JA, Knusel B, Gencer B, Wang H, Wu Y, Kassahun H, Sabatine MS. Study design and rationale for the Olpasiran trials of Cardiovascular Events And lipoproteiN(a) reduction-DOSE finding study (OCEAN(a)-DOSE). Am Heart J. 2022 Sep;251:61-69. doi: 10.1016/j.ahj.2022.05.004. Epub 2022 May 16.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
The Treatment Period was 48 weeks with investigational product (IP) administered subcutaneously (SC) every 12 weeks (Q12W) or 24 weeks (Q24W). After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks. Participants remained on standard of care per their local guidelines during the Treatment Period and Extended Safety Follow-up Period.
Recruitment Details
This study was conducted at 34 centers in Australia, Denmark, Iceland, the Netherlands, Canada, the United States, and Japan between 28 July 2020 and 08 November 2022.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group 1: Olpasiran 10 mg Q12W
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
FG001
Group 2: Olpasiran 75 mg Q12W
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 2, 2022
Aug 1, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
AMG 890
Placebo
Drug
Dose 5
Arm 5 Placebo Dose 5
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Baseline; Week 36 and Week 48
Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at Week 36 and Week 48
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Baseline; Week 36 and Week 48
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
Pharmacokinetic blood draws were collected at one timepoint during the 6-12 and 24-72 hour flexible time windows and at Week 48.
Lower limit of quantification (LLOQ) = 0.400 ng/mL. Values below the LLOQ were set to zero.
Pre-dose and 1, 3, 6-12, and 24-72 hours post-dose on Day 1 and Week 24; Week 48
Boca Raton
Florida
33434
United States
Piedmont Healthcare
Atlanta
Georgia
30309
United States
University of Kansas Medical Center
Kansas City
Kansas
66160
United States
Johns Hopkins
Baltimore
Maryland
21287
United States
New York University
New York
New York
10016
United States
Mount Sinai Hospital
New York
New York
10029
United States
Columbia University Medical Center
New York
New York
10032
United States
Crossroads Clinical Research Inc
Mooresville
North Carolina
28117
United States
Cleveland Clinic
Cleveland
Ohio
44195
United States
Baylor College of Medicine
Houston
Texas
77030
United States
Protenium Clinical Research
Hurst
Texas
76054
United States
Royal Prince Alfred Hospital
Camperdown
New South Wales
2050
Australia
Core Research Group Pty Ltd
Milton
Queensland
4064
Australia
Monash Medical Centre
Clayton
Victoria
3168
Australia
Linear Clinical Research Limited
Nedlands
Western Australia
6009
Australia
Dr Heart Pty Ltd
Woolloongabba
4102
Australia
LMC Clinical Research Incorporated
Brampton
Ontario
L6S 0C6
Canada
LMC Clinical Research Incorporated Thornhill
Concord
Ontario
L4K 4M2
Canada
Ecogene-21
Chicoutimi
Quebec
G7H 7K9
Canada
Research Institute of McGill University Health Center - Glen Site
Montreal
Quebec
H4A 3J1
Canada
Clinique des Maladies Lipidiques de Quebec Incorporated
Québec
Quebec
G1V 4W2
Canada
Aarhus Universitetshospital
Aarhus N
8200
Denmark
Herlev Gentofte Hospital
Herlev
2730
Denmark
Regionshospitalet Viborg
Viborg
8800
Denmark
Thjonustumidstod Rannsoknaverkefna
Kopavogur
201
Iceland
Asahi General Hospital
Asahi-shi
Chiba
289-2511
Japan
The Jikei University Kashiwa Hospital
Kashiwa-shi
Chiba
277-8567
Japan
Asahikawa City Hospital
Asahikawa-shi
Hokkaido
070-8610
Japan
Kanazawa Medical University Hospital
Kahoku-gun
Ishikawa-ken
920-0293
Japan
Saitama Medical University Hospital
Iruma-gun
Saitama
350-0495
Japan
Academisch Medisch Centrum
Amsterdam
1105 AZ
Netherlands
Rijnstate Ziekenhuis
Arnhem
6815 AD
Netherlands
Haga Ziekenhuis
The Hague
2545 AA
Netherlands
Universitair Medisch Centrum Utrecht
Utrecht
3584 CX
Netherlands
VieCuri Medisch Centrum
Venlo
5912 BL
Netherlands
O'Donoghue ML, Rosenson RS, Gencer B, Lopez JAG, Lepor NE, Baum SJ, Stout E, Gaudet D, Knusel B, Kuder JF, Ran X, Murphy SA, Wang H, Wu Y, Kassahun H, Sabatine MS; OCEAN(a)-DOSE Trial Investigators. Small Interfering RNA to Reduce Lipoprotein(a) in Cardiovascular Disease. N Engl J Med. 2022 Nov 17;387(20):1855-1864. doi: 10.1056/NEJMoa2211023. Epub 2022 Nov 6.
O'Donoghue ML, Rosenson RS, Lopez JAG, Lepor NE, Baum SJ, Stout E, Gaudet D, Knusel B, Kuder JF, Murphy SA, Wang H, Wu Y, Shah T, Wang J, Wilmanski T, Sohn W, Kassahun H, Sabatine MS; OCEAN(a)-DOSE Trial Investigators. The Off-Treatment Effects of Olpasiran on Lipoprotein(a) Lowering: OCEAN(a)-DOSE Extension Period Results. J Am Coll Cardiol. 2024 Aug 27;84(9):790-797. doi: 10.1016/j.jacc.2024.05.058.
Kaur G, Rosenson RS, Gencer B, Lopez JAG, Lepor NE, Baum SJ, Stout E, Gaudet D, Knusel B, Park JG, Wang H, Wu Y, Kassahun H, Sabatine MS, O'Donoghue ML. Olpasiran lowering of lipoprotein(a) according to baseline levels: insights from the OCEAN(a)-DOSE study. Eur Heart J. 2025 Mar 24;46(12):1162-1164. doi: 10.1093/eurheartj/ehae781. No abstract available.
Zimerman A, Lopez JAG, Rosenson RS, Gaudet D, Baum SJ, Park JG, Wang J, Wang H, Wu Y, Kassahun H, Sabatine MS, O'Donoghue ML. Small-Interfering RNA Olpasiran and Apolipoprotein B Particles. JAMA Cardiol. 2025 Dec 1;10(12):1322-1324. doi: 10.1001/jamacardio.2025.4105.
Karp A, Jacobs M, Barris B, Labkowsky A, Frishman WH. Lipoprotein(a): A Review of Risk Factors, Measurements, and Novel Treatment Modalities. Cardiol Rev. 2025 Jul-Aug 01;33(4):352-358. doi: 10.1097/CRD.0000000000000667. Epub 2024 Feb 28.
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
FG002
Group 3: Olpasiran 225 mg Q12W
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
FG003
Group 4: Olpasiran 225 mg Q24W
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
FG004
Group 5: Placebo Q12W
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
FG00058 subjects
FG00158 subjects
FG00256 subjects
FG00355 subjects
FG00454 subjects
Entered Extended Safety Follow-up Period
FG00057 subjects
FG00157 subjects
FG00254 subjects
FG00355 subjects
FG00453 subjects
COMPLETED
FG00057 subjects
FG00155 subjects
FG00252 subjects
FG00355 subjects
FG00453 subjects
NOT COMPLETED
FG0001 subjects
FG0013 subjects
FG0024 subjects
FG0030 subjects
FG0041 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Full Analysis Set (FAS): includes all randomized participants who received at least one dose of IP.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1: Olpasiran 10 mg Q12W
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
BG001
Group 2: Olpasiran 75 mg Q12W
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
BG002
Group 3: Olpasiran 225 mg Q12W
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
BG003
Group 4: Olpasiran 225 mg Q24W
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
BG004
Group 5: Placebo Q12W
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00058
BG00158
BG00256
BG00355
BG00454
BG005281
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
BG00063.4± 9.5
BG00161.3± 9.2
BG00259.7± 10.1
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
18 - 64 years
BG00031
BG00135
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00012
BG00123
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian
BG0006
BG0015
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
Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Participants in the FAS with data available at each time point. FAS: includes all randomized participants who received at least one dose of IP.
Posted
Least Squares Mean
Standard Error
Percentage Change in Lp(a)
Baseline and Week 36
ID
Title
Description
OG000
Group 1: Olpasiran 10 mg Q12W
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
OG001
Group 2: Olpasiran 75 mg Q12W
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
OG002
Group 3: Olpasiran 225 mg Q12W
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
OG003
Group 4: Olpasiran 225 mg Q24W
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
OG004
Group 5: Placebo Q12W
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
Units
Counts
Participants
OG00057
OG00157
OG00253
OG003
Title
Denominators
Categories
Title
Measurements
OG000-66.91± 1.78
OG001-93.78± 1.78
OG002-97.53± 1.82
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
OG004
Group 1 versus (vs) Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.
Treatment difference
-70.51
Standard Error of the Mean
2.35
2-Sided
95
-75.12
-65.90
Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.
Secondary
Percentage Change From Baseline in Lp(a) at Week 48
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Participants in the FAS with data available at each time point. FAS: includes all randomized participants who received at least one dose of IP.
Posted
Least Squares Mean
Standard Error
Percentage Change in Lp(a)
Baseline and Week 48
ID
Title
Description
OG000
Group 1: Olpasiran 10 mg Q12W
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
OG001
Group 2: Olpasiran 75 mg Q12W
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
OG002
Group 3: Olpasiran 225 mg Q12W
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
Secondary
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 36 and Week 48
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Participants in the FAS with data available at each time point. FAS: includes all randomized participants who received at least one dose of IP.
Posted
Least Squares Mean
Standard Error
Percentage Change in LDL-C
Baseline; Week 36 and Week 48
ID
Title
Description
OG000
Group 1: Olpasiran 10 mg Q12W
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
OG001
Group 2: Olpasiran 75 mg Q12W
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
OG002
Group 3: Olpasiran 225 mg Q12W
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
Secondary
Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at Week 36 and Week 48
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Participants in the FAS with data available at each time point. FAS: includes all randomized participants who received at least one dose of IP.
Posted
Least Squares Mean
Standard Error
Percentage Change in ApoB
Baseline; Week 36 and Week 48
ID
Title
Description
OG000
Group 1: Olpasiran 10 mg Q12W
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
OG001
Group 2: Olpasiran 75 mg Q12W
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
OG002
Group 3: Olpasiran 225 mg Q12W
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
Secondary
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
Pharmacokinetic blood draws were collected at one timepoint during the 6-12 and 24-72 hour flexible time windows and at Week 48.
Lower limit of quantification (LLOQ) = 0.400 ng/mL. Values below the LLOQ were set to zero.
Participants in the FAS with data available at each time point. FAS: includes all randomized participants who received at least one dose of IP.
Posted
Mean
Standard Deviation
ng/mL
Pre-dose and 1, 3, 6-12, and 24-72 hours post-dose on Day 1 and Week 24; Week 48
ID
Title
Description
OG000
Group 1: Olpasiran 10 mg Q12W
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
OG001
Group 2: Olpasiran 75 mg Q12W
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
OG002
Group 3: Olpasiran 225 mg Q12W
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
Time Frame
Treatment Period: Median duration was 11.07 months. Extended Safety Follow-up Period: Median duration was 8.56 months.
Description
FAS: includes all randomized participants who received at least one dose of IP. For safety analysis FAS was used based on actual treatment 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
Group 1; Treatment Period: Olpasiran 10 mg Q12W
Participants were administered SC olpasiran 10 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36.
0
58
3
58
35
58
EG001
Group 2; Treatment Period: Olpasiran 75 mg Q12W
Participants were administered SC olpasiran 75 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36.
0
58
3
58
40
58
EG002
Group 3; Treatment Period: Olpasiran 225 mg Q12W
Participants were administered SC olpasiran 225 mg Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36.
0
56
6
56
37
56
EG003
Group 4; Treatment Period: Olpasiran 225 mg Q24W
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24.
0
55
4
55
36
55
EG004
Group 5; Treatment Period: Placebo Q12W
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36.
1
54
8
54
29
54
EG005
Group 1; Extended Safety Follow-up Period: Olpasiran 10 mg Q12W
After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.
0
57
4
57
18
57
EG006
Group 2; Extended Safety Follow-up Period: Olpasiran 75 mg Q12W
After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.
0
57
2
57
25
57
EG007
Group 3; Extended Safety Follow-up Period: Olpasiran 225 mg Q12W
After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.
0
54
6
54
21
54
EG008
Group 4; Extended Safety Follow-up Period: Olpasiran 225 mg Q24W
After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.
0
55
5
55
17
55
EG009
Group 5; Extended Safety Follow-up: Placebo Q12W
After Week 48 there was an extended safety follow-up without further dosing with IP for a minimum of 24 weeks.
0
53
4
53
17
53
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG0030 affected55 at risk
EG0041 affected54 at risk
EG0051 affected57 at risk
EG0060 affected57 at risk
EG0070 affected54 at risk
EG0080 affected55 at risk
EG0090 affected53 at risk
Angina unstable
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected58 at risk
EG0021 affected56 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Cataract
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0021 affected56 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Injection site reaction
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0021 affected56 at risk
EG003
Injection site urticaria
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0021 affected56 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected58 at risk
EG0020 affected56 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Campylobacter infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Diverticulitis intestinal perforated
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Influenza
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Vestibular neuronitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected58 at risk
EG0020 affected56 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected58 at risk
EG0020 affected56 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0021 affected56 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected58 at risk
EG0020 affected56 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0021 affected56 at risk
EG003
Breast cancer stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Gastrointestinal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Gastrointestinal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Malignant melanoma stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0021 affected56 at risk
EG003
Metastases to pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Prostate cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Partial seizures
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Seizure
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Syncope
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Device inappropriate shock delivery
Product Issues
MedDRA 25.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Depression
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected58 at risk
EG0020 affected56 at risk
EG003
Urinoma
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected58 at risk
EG0020 affected56 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0021 affected56 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0021 affected56 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Iliac artery occlusion
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0021 affected56 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0003 affected58 at risk
EG0011 affected58 at risk
EG0020 affected56 at risk
EG0031 affected55 at risk
EG0040 affected54 at risk
EG0051 affected57 at risk
EG0062 affected57 at risk
EG0071 affected54 at risk
EG0080 affected55 at risk
EG0091 affected53 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected58 at risk
EG0023 affected56 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0003 affected58 at risk
EG0010 affected58 at risk
EG0021 affected56 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected58 at risk
EG0013 affected58 at risk
EG0023 affected56 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected58 at risk
EG0011 affected58 at risk
EG0021 affected56 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected58 at risk
EG0011 affected58 at risk
EG0022 affected56 at risk
EG003
Fatigue
General disorders
MedDRA 25.1
Systematic Assessment
EG0006 affected58 at risk
EG0018 affected58 at risk
EG0023 affected56 at risk
EG003
Injection site bruising
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0014 affected58 at risk
EG0025 affected56 at risk
EG003
Injection site erythema
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0013 affected58 at risk
EG0023 affected56 at risk
EG003
Injection site pain
General disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected58 at risk
EG0013 affected58 at risk
EG0021 affected56 at risk
EG003
Injection site pruritus
General disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected58 at risk
EG0020 affected56 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected58 at risk
EG0012 affected58 at risk
EG0021 affected56 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected58 at risk
EG0011 affected58 at risk
EG0021 affected56 at risk
EG003
Immunisation reaction
Immune system disorders
MedDRA 25.1
Systematic Assessment
EG0008 affected58 at risk
EG0014 affected58 at risk
EG0022 affected56 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 affected58 at risk
EG0018 affected58 at risk
EG0027 affected56 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 affected58 at risk
EG0014 affected58 at risk
EG0020 affected56 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0002 affected58 at risk
EG0012 affected58 at risk
EG0024 affected56 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0013 affected58 at risk
EG0020 affected56 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0004 affected58 at risk
EG0013 affected58 at risk
EG0022 affected56 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0003 affected58 at risk
EG0014 affected58 at risk
EG0022 affected56 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected58 at risk
EG0021 affected56 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0002 affected58 at risk
EG0013 affected58 at risk
EG0021 affected56 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0003 affected58 at risk
EG0013 affected58 at risk
EG0021 affected56 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected58 at risk
EG0013 affected58 at risk
EG0023 affected56 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0006 affected58 at risk
EG0015 affected58 at risk
EG0027 affected56 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0003 affected58 at risk
EG0011 affected58 at risk
EG0024 affected56 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected58 at risk
EG0011 affected58 at risk
EG0020 affected56 at risk
EG003
Areflexia
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0013 affected58 at risk
EG0020 affected56 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected58 at risk
EG0013 affected58 at risk
EG0022 affected56 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0006 affected58 at risk
EG0017 affected58 at risk
EG0026 affected56 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0003 affected58 at risk
EG0011 affected58 at risk
EG0020 affected56 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0004 affected58 at risk
EG0012 affected58 at risk
EG0023 affected56 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 Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.
Treatment difference
-97.38
Standard Error of the Mean
2.35
2-Sided
95
-101.98
-92.77
Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.
Superiority
OG002
OG004
Group 3 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.
Treatment difference
-101.13
Standard Error of the Mean
2.38
2-Sided
95
-105.79
-96.47
Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.
Superiority
OG003
OG004
Group 4 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
< 0.001
Treatment difference
-100.49
Standard Error of the Mean
2.38
2-Sided
95
-105.16
-95.82
Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.
Superiority
OG003
Group 4: Olpasiran 225 mg Q24W
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
OG004
Group 5: Placebo Q12W
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
Units
Counts
Participants
OG00057
OG00157
OG00254
OG00353
OG00451
Title
Denominators
Categories
Title
Measurements
OG000-64.89± 2.17
OG001-92.54± 2.17
OG002-97.29± 2.22
OG003-82.36± 2.25
OG0043.59± 2.30
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
OG004
Group 1 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-68.47
Standard Error of the Mean
2.96
2-Sided
95
-74.27
-62.67
Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.
Superiority
OG001
OG004
Group 2 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-96.12
Standard Error of the Mean
2.96
2-Sided
95
-101.92
-90.33
Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.
Superiority
OG002
OG004
Group 3 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-100.88
Standard Error of the Mean
2.99
2-Sided
95
-106.74
-95.02
Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.
Superiority
OG003
OG004
Group 4 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
< 0.001
Treatment difference
-85.94
Standard Error of the Mean
3.00
2-Sided
95
-91.83
-80.06
Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.
Superiority
OG003
Group 4: Olpasiran 225 mg Q24W
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
OG004
Group 5: Placebo Q12W
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
Units
Counts
Participants
OG00057
OG00157
OG00254
OG00353
OG00451
Title
Denominators
Categories
Week 36
ParticipantsOG00057
ParticipantsOG00157
ParticipantsOG00253
ParticipantsOG00353
ParticipantsOG00451
Title
Measurements
OG000-17.425± 4.258
OG001-16.284± 4.259
OG002-16.733± 4.389
OG003
Week 48
ParticipantsOG00057
ParticipantsOG00157
ParticipantsOG00254
ParticipantsOG00352
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
OG004
Week 36: Group 1 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-23.659
Standard Error of the Mean
5.874
2-Sided
95
-35.176
-12.143
Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.
Superiority
OG001
OG004
Week 36: Group 2 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-22.518
Standard Error of the Mean
5.875
2-Sided
95
-34.036
-11.000
Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.
Superiority
OG002
OG004
Week 36: Group 3 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-22.967
Standard Error of the Mean
5.962
2-Sided
95
-34.656
-11.278
Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.
Superiority
OG003
OG004
Week 36: Group 4 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
< 0.001
Treatment difference
-24.696
Standard Error of the Mean
5.969
2-Sided
95
-36.399
-12.993
Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.
Superiority
OG000
OG004
Week 48: Group 1 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-24.856
Standard Error of the Mean
6.119
2-Sided
95
-36.853
-12.859
Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.
Superiority
OG001
OG004
Week 48: Group 2 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-21.594
Standard Error of the Mean
6.118
2-Sided
95
-33.590
-9.598
Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.
Superiority
OG002
OG004
Week 48: Group 3 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-27.421
Standard Error of the Mean
6.194
2-Sided
95
-39.565
-15.277
Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.
Superiority
OG003
OG004
Week 48: Group 4 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-27.021
Standard Error of the Mean
6.232
2-Sided
95
-39.240
-14.801
Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.
Superiority
OG003
Group 4: Olpasiran 225 mg Q24W
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
OG004
Group 5: Placebo Q12W
Participants were administered SC placebo Q12W for 48 weeks with doses at Day 1, Week 12, Week 24, and Week 36. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.
Units
Counts
Participants
OG00057
OG00157
OG00254
OG00353
OG00452
Title
Denominators
Categories
Week 36
Title
Measurements
OG000-11.496± 2.886
OG001-9.302± 2.885
OG002-10.241± 2.960
OG003-11.378± 3.012
OG0047.394± 3.066
Week 48
Title
Measurements
OG000-7.748± 3.307
OG001-4.768± 3.305
OG002-7.218± 3.393
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
OG004
Week 36: Group 1 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-18.890
Standard Error of the Mean
3.779
2-Sided
95
-26.303
-11.477
Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.
Superiority
OG001
OG004
Week 36: Group 2 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-16.696
Standard Error of the Mean
3.778
2-Sided
95
-24.107
-9.284
Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.
Superiority
OG002
OG004
Week 36: Group 3 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-17.635
Standard Error of the Mean
3.825
2-Sided
95
-25.139
-10.131
Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.
Superiority
OG003
OG004
Week 36: Group 4 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
< 0.001
Treatment difference
-18.772
Standard Error of the Mean
3.839
2-Sided
95
-26.303
-11.241
Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.
Superiority
OG000
OG004
Week 48: Group 1 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-20.040
Standard Error of the Mean
4.443
2-Sided
95
-28.757
-11.323
Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.
Superiority
OG001
OG004
Week 48: Group 2 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-17.060
Standard Error of the Mean
4.442
2-Sided
95
-25.774
-8.345
Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.
Superiority
OG002
OG004
Week 48: Group 3 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-19.509
Standard Error of the Mean
4.500
2-Sided
95
-28.336
-10.682
Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.
Superiority
OG003
OG004
Week 48: Group 4 vs Group 5
Repeated measures linear effects model
Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.
<0.001
Treatment difference
-21.839
Standard Error of the Mean
4.517
2-Sided
95
-30.700
-12.979
Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.
Superiority
OG003
Group 4: Olpasiran 225 mg Q24W
Participants were administered SC olpasiran 225 mg Q24W for 48 weeks with doses at Day 1 and Week 24. After Week 48 there was an Extended Safety Follow-up Period without further dosing with IP for a minimum of 24 weeks.