Cardiovascular DiseasePhase 2NCT04270760
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
A Phase 2 study testing Olpasiran in people with Cardiovascular Disease, run by Amgen at 36 sites in 7 countries.
Trial summary
Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Olpasiran
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 281 participants
- Where
- 36 sitesin 7 countries
- Study dates
- 28 Jul 2020to 8 Nov 2022
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years
- Lipoprotein (a) > 150 nmol/L
- Evidence of atherosclerotic cardiovascular disease
Who cannot join
- 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
Trial locations and contacts
36 sites in 7 countries.
36 sites in 7 countries
United States12 sites
Piedmont Healthcare
Atlanta, Georgia, 30309
Johns Hopkins
Baltimore, Maryland, 21287
Westside Medical Associates of Los Angeles
Beverly Hills, California, 90211
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
Cleveland Clinic
Cleveland, Ohio, 44195
Baylor College of Medicine
Houston, Texas, 77030
Protenium Clinical Research
Hurst, Texas, 76054
University of Kansas Medical Center
Kansas City, Kansas, 66160
Crossroads Clinical Research Inc
Mooresville, North Carolina, 28117
New York University
New York, New York, 10016
Mount Sinai Hospital
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Australia5 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Monash Medical Centre
Clayton, Victoria, 3168
Core Research Group Pty Ltd
Milton, Queensland, 4064
Linear Clinical Research Limited
Nedlands, Western Australia, 6009
Dr Heart Pty Ltd
Woolloongabba, 4102
Canada5 sites
LMC Clinical Research Incorporated
Brampton, Ontario, L6S 0C6
Ecogene-21
Chicoutimi, Quebec, G7H 7K9
LMC Clinical Research Incorporated Thornhill
Concord, Ontario, L4K 4M2
Research Institute of McGill University Health Center - Glen Site
Montreal, Quebec, H4A 3J1
Clinique des Maladies Lipidiques de Quebec Incorporated
Québec, Quebec, G1V 4W2
Japan5 sites
Asahi General Hospital
Asahi-shi, Chiba, 289-2511
Asahikawa City Hospital
Asahikawa-shi, Hokkaido, 070-8610
Saitama Medical University Hospital
Iruma-gun, Saitama, 350-0495
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa-ken, 920-0293
The Jikei University Kashiwa Hospital
Kashiwa-shi, Chiba, 277-8567
Netherlands5 sites
Academisch Medisch Centrum
Amsterdam, 1105 AZ
Rijnstate Ziekenhuis
Arnhem, 6815 AD
Haga Ziekenhuis
The Hague, 2545 AA
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
VieCuri Medisch Centrum
Venlo, 5912 BL
Denmark3 sites
Aarhus Universitetshospital
Aarhus N, 8200
Herlev Gentofte Hospital
Herlev, 2730
Regionshospitalet Viborg
Viborg, 8800
About this 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)
Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]).
- Conditions
- Cardiovascular Disease
- Being tested
- Olpasiran, Placebo
- Keywords
- Olpasiran, AMG 890, siRNA, lipoprotein (a) Lp(a), Cardiovascular, Cardiovascular disease, Atherosclerotic cardiovascular disease, Cholesterol, Apolipoprotein (B), Hyperlipidemia, Dyslipidemia
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis, Hyperlipidemias, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlpasiranDrug
Also called AMG 890
Dose 1 Dose 2 Dose 3 Dose 4
PlaceboDrug
Dose 5
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Olpasiran Dose 1 | Active comparator | Not described Receives: Drug: Olpasiran |
| Arm 2 Olpasiran Dose 2 | Active comparator | Not described Receives: Drug: Olpasiran |
| Arm 3 Olpasiran Dose 3 | Active comparator | Not described Receives: Drug: Olpasiran |
| Arm 4 Olpasiran Dose 4 | Active comparator | Not described Receives: Drug: Olpasiran |
| Arm 5 Placebo Dose 5 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 36
Secondary outcomes (4)
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.
Measured: Baseline and Week 48
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.
Measured: 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.
Measured: 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.
Measured: Pre-dose and 1, 3, 6-12, and 24-72 hours post-dose on Day 1 and Week 24; Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start28 Jul 2020
- Primary completion27 Dec 2021
- Study completion8 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270760
- Sponsor's protocol ID
- 20180109
- Other IDs
- 2019-003688-23, 2019
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2020
- Last updated
- 31 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Publications
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.
PubMed 35588897O'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.
PubMed 36342163O'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.
PubMed 39168564Kaur 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.
PubMed 39565305Rosenson 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.
PubMed 39937508Zimerman 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.
PubMed 41191372Karp 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.
PubMed 38415744