Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
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)
2 other identifiers
interventional
281
7 countries
36
Brief Summary
Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp\[a\]).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2020
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedStudy Start
First participant enrolled
July 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2022
CompletedResults Posted
Study results publicly available
August 23, 2023
CompletedMarch 31, 2026
March 1, 2026
1.4 years
February 13, 2020
August 1, 2023
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (4)
Percentage Change From Baseline in Lp(a) at Week 48
Baseline and Week 48
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 36 and Week 48
Baseline; Week 36 and Week 48
Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at Week 36 and Week 48
Baseline; Week 36 and Week 48
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
Pre-dose and 1, 3, 6-12, and 24-72 hours post-dose on Day 1 and Week 24; Week 48
Study Arms (5)
Arm 1 Olpasiran Dose 1
ACTIVE COMPARATORArm 2 Olpasiran Dose 2
ACTIVE COMPARATORArm 3 Olpasiran Dose 3
ACTIVE COMPARATORArm 4 Olpasiran Dose 4
ACTIVE COMPARATORArm 5 Placebo Dose 5
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age 18 to 80 years
- Lipoprotein (a) \> 150 nmol/L
- Evidence of atherosclerotic cardiovascular disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (36)
Westside Medical Associates of Los Angeles
Beverly Hills, California, 90211, United States
Excel Medical Clinical Trials
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
Related Publications (7)
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.
PMID: 35588897BACKGROUNDO'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.
PMID: 36342163BACKGROUNDO'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.
PMID: 39168564BACKGROUNDKaur 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.
PMID: 39565305BACKGROUNDRosenson RS, Lopez JAG, Gaudet D, Baum SJ, Stout E, Lepor NE, Park JG, Murphy SA, Knusel B, Wang J, Wilmanski T, Wang H, Wu Y, Kassahun H, Sabatine MS, O'Donoghue ML; OCEAN(a)-DOSE Trial Investigators. Olpasiran, Oxidized Phospholipids, and Systemic Inflammatory Biomarkers: Results From the OCEAN(a)-DOSE Trial. JAMA Cardiol. 2025 May 1;10(5):482-486. doi: 10.1001/jamacardio.2024.5433.
PMID: 39937508BACKGROUNDZimerman 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.
PMID: 41191372BACKGROUNDKarp 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.
PMID: 38415744DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2020
First Posted
February 17, 2020
Study Start
July 28, 2020
Primary Completion
December 27, 2021
Study Completion
November 8, 2022
Last Updated
March 31, 2026
Results First Posted
August 23, 2023
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request