Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) in Participants With Hyperlipoproteinemia(a) and Cardiovascular Disease
NCT ID: NCT03070782
Last Updated: 2020-10-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
286 participants
INTERVENTIONAL
2017-03-07
2018-11-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort A: ISIS 681257: 20 mg Q4W
Cohort A participants received 20 milligrams (mg) ISIS 681257, subcutaneous (SC) injection, once every 4 weeks (Q4W), for up to 49 weeks and a maximum of 13 doses.
ISIS 681257
ISIS 681257 solution for SC injection.
Cohort B: ISIS 681257: 40 mg Q4W
Cohort B participants received 40 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses.
ISIS 681257
ISIS 681257 solution for SC injection.
Cohort C: ISIS 681257: 60 mg Q4W
Cohort C participants received 60 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses.
ISIS 681257
ISIS 681257 solution for SC injection.
Cohort D: ISIS 681257: 20 mg Q2W
Cohort D participants received 20 mg of ISIS 681257, SC injection, once every 2 weeks (Q2W), for up to 51 weeks and a maximum of 26 doses.
ISIS 681257
ISIS 681257 solution for SC injection.
Cohort E: ISIS 681257: 20 mg QW
Cohort E participants received 20 mg of ISIS 681257, SC injection, once weekly (QW), for up to 52 weeks and a maximum of 52 doses.
ISIS 681257
ISIS 681257 solution for SC injection.
Placebo
Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 681257).
Placebo
Sterile normal saline (0.9% NaCl)
Interventions
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ISIS 681257
ISIS 681257 solution for SC injection.
Placebo
Sterile normal saline (0.9% NaCl)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Lp(a) plasma level ≥ 60 mg/dL
* Must be on standard-of-care preventative therapy for other than elevated Lp(a) CVD risk factors
Exclusion Criteria
* Within 3 months of Screening: coronary, carotid, or peripheral arterial revascularization, major non-cardiac surgery, or lipoprotein apheresis
* Heart failure New York Heart Association (NYHA) class IV
18 Years
80 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Akcea Therapeutics
INDUSTRY
Responsible Party
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Locations
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Clinical Site
Cottonwood, Arizona, United States
Clinical Site
Huntington Beach, California, United States
Clinical Site
La Jolla, California, United States
Clinical Site
Los Angeles, California, United States
Clinical Site
Stanford, California, United States
Clinical Site
Colorado Springs, Colorado, United States
Clinical Site
Boca Raton, Florida, United States
Clinical Site
Jacksonville, Florida, United States
Clinical Site
Kansas City, Kansas, United States
Clinical Site
Baltimore, Maryland, United States
Clinical Site
Boston, Massachusetts, United States
Clinical Site
Cooperstown, New York, United States
Clinical Site
New York, New York, United States
Clinical Site
New York, New York, United States
Clinical Site
Cleveland, Ohio, United States
Clinical Site
Portland, Oregon, United States
Clinical Site
Lancaster, Pennsylvania, United States
Clinical Site
Philadelphia, Pennsylvania, United States
Clinical Site
Providence, Rhode Island, United States
Clinical Site
Houston, Texas, United States
Clinical Site
Falls Church, Virginia, United States
Clinical Site
Milwaukee, Wisconsin, United States
Clinical Site
Chicoutimi, Quebec, Canada
Clinical Site
Montreal, Quebec, Canada
Clinical Site
Montreal, Quebec, Canada
Clinical Site
Québec, Quebec, Canada
Clinical Site
Ottawa, , Canada
Clinical Site
Herlev, , Denmark
Clinical Site
Viborg, , Denmark
Clinical Site
Berlin, , Germany
Clinical Site
Cologne, , Germany
Clinical Site
Amsterdam, , Netherlands
Countries
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References
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Tekendo-Ngongang C, Gleeson JG, Mignon L. Treating the Untreatable: Antisense Oligonucleotides as an Individualized Therapy for Rare Genetic Kidney Diseases. J Am Soc Nephrol. 2024 Dec 1;35(12):1774-1777. doi: 10.1681/ASN.0000000532. Epub 2024 Sep 27. No abstract available.
Stiekema LCA, Prange KHM, Hoogeveen RM, Verweij SL, Kroon J, Schnitzler JG, Dzobo KE, Cupido AJ, Tsimikas S, Stroes ESG, de Winther MPJ, Bahjat M. Potent lipoprotein(a) lowering following apolipoprotein(a) antisense treatment reduces the pro-inflammatory activation of circulating monocytes in patients with elevated lipoprotein(a). Eur Heart J. 2020 Jun 21;41(24):2262-2271. doi: 10.1093/eurheartj/ehaa171.
Tsimikas S, Karwatowska-Prokopczuk E, Gouni-Berthold I, Tardif JC, Baum SJ, Steinhagen-Thiessen E, Shapiro MD, Stroes ES, Moriarty PM, Nordestgaard BG, Xia S, Guerriero J, Viney NJ, O'Dea L, Witztum JL; AKCEA-APO(a)-LRx Study Investigators. Lipoprotein(a) Reduction in Persons with Cardiovascular Disease. N Engl J Med. 2020 Jan 16;382(3):244-255. doi: 10.1056/NEJMoa1905239. Epub 2020 Jan 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003373-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ISIS 681257-CS6
Identifier Type: -
Identifier Source: org_study_id