A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)]
NCT ID: NCT05565742
Last Updated: 2025-05-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
320 participants
INTERVENTIONAL
2022-10-20
2024-10-17
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
DOUBLE
Study Groups
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16 mg LY3819469
Participants received 16 milligrams (mg) of LY3819469 on day 1 and day 180, administered as a subcutaneous (SC) injection.
LY3819469
Administered SC
96 mg LY3819469
Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
LY3819469
Administered SC
400 mg LY3819469
Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
LY3819469
Administered SC
400 mg LY3819469 + Placebo
Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
LY3819469
Administered SC
Placebo
Administered SC
Placebo
Participants received placebo on day 1 and day 180, administered as a SC injection.
Placebo
Administered SC
Interventions
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LY3819469
Administered SC
Placebo
Administered SC
Eligibility Criteria
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Inclusion Criteria
* Participants with Lp(a) ≥175 nmol/L at screening, measured at the central laboratory
* Participants on the following medications according to local practice must be on a stable regimen for at least 4 weeks prior to screening and randomization and expected to remain on a stable regimen through the end of the Treatment and Assessment Period:
* lipid-lowering drugs
* testosterone, estrogens, anti-estrogens, progestins, selective estrogen receptor modulators, or growth hormone
* Have a body mass index within the range 18.5 to 40 kilogram/square meter (kg/m²), inclusive.
Male and/or Female
* Males who agree to use highly effective/effective methods of contraception may participate in this trial.
* Women not of childbearing potential (WNOCBP) may participate in this trial.
Exclusion Criteria
* Any of the following, or other events indicating unstable medical condition in the opinion of the investigator, within 3 months of randomization:
* major surgery
* coronary, carotid, or peripheral arterial revascularization
* stroke or transient ischemic attack
* myocardial infarction or unstable angina
* acute limb ischemia
* Have, in the 6 months prior to day 1, uncontrolled Type 1 or Type 2 diabetes.
* Have uncontrolled hypertension
40 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Care Access - 801 South Power Road, Mesa
Mesa, Arizona, United States
Care Access - South Pasadena
Pasadena, California, United States
Care Access - Santa Clarita
Santa Clarita, California, United States
Care Access - Spring Hill
Spring Hill, Florida, United States
Care Access - Pebble Beach Boulevard, Tampa
Sun City, Florida, United States
Care Access - Tamarac
Tamarac, Florida, United States
Care Access - Tampa
Tampa, Florida, United States
Care Access - Lake Charles
Lake Charles, Louisiana, United States
Care Access - Baltimore
Baltimore, Maryland, United States
Care Access - Dorchester
Dorchester, Massachusetts, United States
Aventiv Research Inc
Columbus, Ohio, United States
Care Access - Lima
Lima, Ohio, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Cardiology Consultants of Philadelphia Yardley
Yardley, Pennsylvania, United States
Care Access - Rapid City
Rapid City, South Dakota, United States
Care Access - Georgetown
Georgetown, Texas, United States
Care Access - Katy
Katy, Texas, United States
Virginia Heart
Falls Church, Virginia, United States
Mautalen Salud e Investigación
Buenos Aires, Buenos Aires F.D., Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina
Glenny Corp. S.A.
Buenos Aires, Ciudad Aut, Argentina
Investigaciones Medicas Imoba Srl
Balvanera, Ciudad Autónoma de Buenos Aire, Argentina
CIPREC
Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina
Centro Modelo de Cardiología
San Miguel de Tucumán, Tucumán Province, Argentina
Investigaciones Clínicas Tucumán
San Miguel de Tucumán, Tucumán Province, Argentina
CEMEDIC
Buenos Aires, , Argentina
Hospital San Roque
Córdoba, , Argentina
Centro Cardiovascular Salta
Salta, , Argentina
Centro de Investigaciones Clinicas del Litoral
Santa Fe, , Argentina
Third People's Hospital of Hainan Province
Sanya, Hainan, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The Third Hospital of Nanchang
Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Sanos Clinic
Herlev, Capital Region, Denmark
Sanos Clinic - Nordjylland
Gandrup, North Denmark, Denmark
Sanos Clinic - Syddanmark
Vejle, Region Syddanmark, Denmark
Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair
Bad Homburg, Hesse, Germany
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, Hesse, Germany
Klinikum Bielefeld Mitte
Bielefeld, North Rhine-Westphalia, Germany
SMO.MD GmbH
Magdeburg, Saxony-Anhalt, Germany
Medizinisches Versorgungszentrum am Bahnhof Spandau
Spandau, State of Berlin, Germany
Kardiologische Praxen im Spreebogen
Berlin, , Germany
Cardiologicum Hamburg
Hamburg, , Germany
Diabeteszentrum Hamburg West
Hamburg, , Germany
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Rinku General Medical Center
Izumisano, Osaka, Japan
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, Japan
Clinical Research Hospital Tokyo
Shinjuku-ku, Tokyo, Japan
Heishinkai Medical Group ToCROM Clinic
Shinjuku-ku, Tokyo, Japan
Miyazaki Medical Association Hospital
Miyazaki, , Japan
AMC Nishiumeda Clinic
Osaka, , Japan
Centro de Investigacion Cardiovascular y Metabólica
Tijuana, Estado de Baja California, Mexico
Virgen Cardiovascular Research SC
Guadalajara, Jalisco, Mexico
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
Culiacán, Sinaloa, Mexico
Fundación Cardiovascular de Aguascalientes A.C.
Aguascalientes, , Mexico
Centro de Estudios Clínicos de Querétaro (CECLIQ)
Querétaro, , Mexico
Amphia Ziekenhuis, locatie Breda Molengracht
Breda, North Brabant, Netherlands
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands
Saxenburgh Medisch Centrum
Hardenberg, Overijssel, Netherlands
Groene Hart Ziekenhuis
Gouda, South Holland, Netherlands
Reinier de Graaf Ziekenhuis, locatie Delft
Delft, Zuid-Holla, Netherlands
Antonius Ziekenhuis, locatie D&A Research and Genetics
Sneek, , Netherlands
Sal Med Srl
Piteşti, Argeş, Romania
C.M.D.T.A. Neomed
Brasov, Brașov County, Romania
Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului
Bucharest, București, Romania
Centrul Medical Endocrinologie si Diabet Dr. Paveliu
Bucharest, București, Romania
Private Practice - Dr. Mercea Corina Delia
Baia Mare, Maramureş, Romania
Cardiomed
Târgu Mureş, Mureș County, Romania
Private Practice - Dr. Cristian Podoleanu
Târgu Mureş, Mureș County, Romania
Centrul Medical Medicalis
Timișoara, Timiș County, Romania
Cardiomed Iași
Iași, , Romania
Hospital Universitario Reina Sofia
Córdoba, Andalusia, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona [Barcelona], Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain
Hospital Unviersitario Virgen Nieves
Granada, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
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References
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Nissen SE, Ni W, Shen X, Wang Q, Navar AM, Nicholls SJ, Wolski K, Michael L, Haupt A, Krege JH; ALPACA Trial Investigators. Lepodisiran - A Long-Duration Small Interfering RNA Targeting Lipoprotein(a). N Engl J Med. 2025 May 1;392(17):1673-1683. doi: 10.1056/NEJMoa2415818. Epub 2025 Mar 30.
Makhmudova U, Steinhagen-Thiessen E, Volpe M, Landmesser U. Advances in nucleic acid-targeted therapies for cardiovascular disease prevention. Cardiovasc Res. 2024 Sep 2;120(10):1107-1125. doi: 10.1093/cvr/cvae136.
Karp 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3819469 in Participants With Elevated Lipoprotein(a) \[Lp(a)\]
Other Identifiers
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J3L-MC-EZEB
Identifier Type: OTHER
Identifier Source: secondary_id
2022-501426-38-00
Identifier Type: CTIS
Identifier Source: secondary_id
18547
Identifier Type: -
Identifier Source: org_study_id
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