Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04270760 |
Recruitment Status :
Recruiting
First Posted : February 17, 2020
Last Update Posted : February 21, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiovascular Disease | Drug: Olpasiran Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | July 28, 2020 |
Estimated Primary Completion Date : | January 17, 2022 |
Estimated Study Completion Date : | April 13, 2023 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Arm 1 Olpasiran Dose 1 |
Drug: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Other Name: AMG 890 |
Active Comparator: Arm 2 Olpasiran Dose 2 |
Drug: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Other Name: AMG 890 |
Active Comparator: Arm 3 Olpasiran Dose 3 |
Drug: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Other Name: AMG 890 |
Active Comparator: Arm 4 Olpasiran Dose 4 |
Drug: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
Other Name: AMG 890 |
Placebo Comparator: Arm 5 Placebo Dose 5 |
Drug: Placebo
Dose 5 |
- Percent change in Lp(a) [ Time Frame: Baseline and week 36 ]
- Percentage change from baseline in Lp(a) [ Time Frame: Baseline and week 48 ]
- Percentage change from baseline in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline and Weeks 36 and 48 ]
- Percentage change in Apolipoprotein(B) (ApoB) [ Time Frame: Baseline and weeks 36 and 48 ]
- Maximum observed concentration (Cmax) of Olpasiran [ Time Frame: 48 weeks ]
- Area under the concentration-time curve (AUC) of Olpasiran [ Time Frame: 48 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04270760
Contact: Amgen Call Center | 866-572-6436 | medinfo@amgen.com |
United States, California | |
Research Site | Recruiting |
Beverly Hills, California, United States, 90211 | |
United States, Florida | |
Research Site | Recruiting |
Boca Raton, Florida, United States, 33434 | |
United States, Georgia | |
Research Site | Recruiting |
Atlanta, Georgia, United States, 30309 | |
United States, Kansas | |
Research Site | Recruiting |
Kansas City, Kansas, United States, 66160 | |
United States, Maryland | |
Research Site | Recruiting |
Baltimore, Maryland, United States, 21287 | |
United States, New York | |
Research Site | Recruiting |
New York, New York, United States, 10016 | |
Research Site | Recruiting |
New York, New York, United States, 10029 | |
Research Site | Recruiting |
New York, New York, United States, 10032 | |
United States, North Carolina | |
Research Site | Recruiting |
Mooresville, North Carolina, United States, 28117 | |
United States, Ohio | |
Research Site | Recruiting |
Cleveland, Ohio, United States, 44195 | |
United States, Texas | |
Research Site | Recruiting |
Houston, Texas, United States, 77030 | |
Research Site | Recruiting |
Hurst, Texas, United States, 76054 | |
Australia, New South Wales | |
Research Site | Recruiting |
Camperdown, New South Wales, Australia, 2050 | |
Australia, Queensland | |
Research Site | Recruiting |
Milton, Queensland, Australia, 4064 | |
Australia, Victoria | |
Research Site | Recruiting |
Clayton, Victoria, Australia, 3168 | |
Australia, Western Australia | |
Research Site | Recruiting |
Nedlands, Western Australia, Australia, 6009 | |
Australia | |
Research Site | Recruiting |
Woolloongabba, Australia, 4102 | |
Canada, Ontario | |
Research Site | Recruiting |
Brampton, Ontario, Canada, L6S 0C6 | |
Research Site | Recruiting |
Concord, Ontario, Canada, L4K 4M2 | |
Canada, Quebec | |
Research Site | Recruiting |
Chicoutimi, Quebec, Canada, G7H 7K9 | |
Research Site | Recruiting |
Montreal, Quebec, Canada, H4A 3J1 | |
Canada | |
Research Site | Recruiting |
Quebec, Canada, G1V 4W2 | |
Denmark | |
Research Site | Recruiting |
Aarhus N, Denmark, 8200 | |
Research Site | Recruiting |
Herlev, Denmark, 2730 | |
Research Site | Recruiting |
Viborg, Denmark, 8800 | |
Iceland | |
Research Site | Recruiting |
Kopavogur, Iceland, 201 | |
Japan | |
Research Site | Recruiting |
Asahi-shi, Chiba, Japan, 289-2511 | |
Research Site | Recruiting |
Kashiwa-shi, Chiba, Japan, 277-8567 | |
Research Site | Recruiting |
Asahikawa-shi, Hokkaido, Japan, 070-8610 | |
Research Site | Recruiting |
Kahoku-gun, Ishikawa, Japan, 920-0293 | |
Research Site | Recruiting |
Iruma-gun, Saitama, Japan, 350-0495 | |
Netherlands | |
Research Site | Recruiting |
Amsterdam, Netherlands, 1105 AZ | |
Research Site | Recruiting |
Arnhem, Netherlands, 6815 AD | |
Research Site | Recruiting |
The Hague, Netherlands, 2545 AA | |
Research Site | Recruiting |
Utrecht, Netherlands, 3584 CX | |
Research Site | Recruiting |
Venlo, Netherlands, 5912 BL |
Study Director: | MD | Amgen |
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT04270760 |
Other Study ID Numbers: |
20180109 2019-003688-23 ( EudraCT Number ) |
First Posted: | February 17, 2020 Key Record Dates |
Last Update Posted: | February 21, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request |
Supporting Materials: |
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. |
URL: | https://www.amgen.com/datasharing |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
AMG 890 Olpasiran siRNA lipoprotein (a) Lp(a) Cardiovascular Cardiovascular disease |
Atherosclerotic cardiovascular disease Cholesterol Apolipoprotein (B) Hyperlipidemia Dyslipidemia |
Cardiovascular Diseases |