Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
NCT ID: NCT03626662
Last Updated: 2026-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
79 participants
INTERVENTIONAL
2018-07-30
2023-04-18
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
OTHER
TRIPLE
Study Groups
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Placebo
Single Ascending Dose Cohorts
Placebo
Calculated volume to match experimental drug.
AMG 890
Single Ascending Dose Cohorts
AMG 890
Ascending Single Doses of AMG 890
Interventions
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AMG 890
Ascending Single Doses of AMG 890
Placebo
Calculated volume to match experimental drug.
Eligibility Criteria
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Inclusion Criteria
* Protocol-defined elevated plasma Lp(a) level.
* Body mass index (BMI) greater than or equal to 18 and less than or equal to 40 kg/m2, at screening.
* Women must be of non-reproductive potential.
Exclusion Criteria
* Women who are lactating/breastfeeding or who plan to breastfeed while on study or through 90 days after receiving the last dose of investigational product (for subjects who withdraw prior to end of study).
* History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
* History or clinical evidence of bleeding diathesis or any coagulation disorder.
* History or clinical evidence of peripheral neuropathy.
18 Years
70 Years
ALL
Yes
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Orange County Research Center
Tustin, California, United States
Excel Medical Clinical Trials
Boca Raton, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
QPS Miami Research Associates
South Miami, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
New York University
New York, New York, United States
Medpace Inc
Cincinnati, Ohio, United States
Clinical Medical and Analytical eXellence CMAX
Adelaide, South Australia, Australia
Linear Clinical Research Limited
Nedlands, Western Australia, Australia
Countries
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References
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Koren MJ, Moriarty PM, Baum SJ, Neutel J, Hernandez-Illas M, Weintraub HS, Florio M, Kassahun H, Melquist S, Varrieur T, Haldar SM, Sohn W, Wang H, Elliott-Davey M, Rock BM, Pei T, Homann O, Hellawell J, Watts GF. Preclinical development and phase 1 trial of a novel siRNA targeting lipoprotein(a). Nat Med. 2022 Jan;28(1):96-103. doi: 10.1038/s41591-021-01634-w. Epub 2022 Jan 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20170544
Identifier Type: -
Identifier Source: org_study_id
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