A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)]
- Registration Number
- NCT05565742
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to determine the efficacy and safety of LY3819469 in adults with elevated lipoprotein(a). The study will lasts about 20 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
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Participants must be at least 40 years old at the time of signing the informed consent.
-
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.
-
Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study or interfere with participating in or completing the study or with the interpretation of data.
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3819469 Dose 4 + Placebo LY3819469 Participants will receive LY3819469 SC and placebo. LY3819469 Dose 4 + Placebo Placebo Participants will receive LY3819469 SC and placebo. LY3819469 Dose 2 LY3819469 Participants will receive LY3819469 SC. LY3819469 Dose 3 LY3819469 Participants will receive LY3819469 SC. Placebo Placebo Participants will receive placebo. LY3819469 Dose 1 LY3819469 Participants will receive LY3819469 subcutaneously (SC).
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Time Averaged Lipoprotein(a) [Lp(a)] Baseline, Days 60 - 180
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline in Apolipoprotein B (ApoB) Baseline to Days 60, 180, 240, 360, and 540 Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3819469 Baseline to Day 540 Population PK parameters will be assessed by AUC
Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (nmol/L) Days 60, 180, 240, 360, and 540 Percent Change from Baseline in Lp(a) Baseline to Days 60, 180, 240, 360, and 540 Percent Change from Baseline in Time Averaged Lp(a) Baseline, 240 - 360 Percent Change from Baseline in High-sensitivity C-reactive Protein (hsCRP) Baseline to Days 60, 180, 240, 360, and 540
Trial Locations
- Locations (80)
Diabeteszentrum Hamburg West
🇩🇪Hamburg, Germany
Cardiomed Iași
🇷🇴Iași, Romania
Glenny Corp. S.A.
🇦🇷Buenos Aires, Ciudad Aut, Argentina
Hyogo Medical University Hospital
🇯🇵Nishinomiya, Hyogo, Japan
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 - Tampa
🇺🇸Tampa, Florida, United States
Care Access - Pebble Beach Boulevard, Tampa
🇺🇸Sun City, Florida, United States
Care Access - Tamarac
🇺🇸Tamarac, 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
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Andalucía, Spain
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina
Mautalen Salud e Investigación
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, 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 Tucuman, Tucumán, Argentina
Investigaciones Clínicas Tucumán
🇦🇷San Miguel de Tucuman, Tucumán, 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, Hovedstaden, Denmark
Sanos Clinic - Nordjylland
🇩🇰Gandrup, Nordjylland, Denmark
Sanos Clinic - Syddanmark
🇩🇰Vejle, Syddanmark, Denmark
Medizinisches Versorgungszentrum am Bahnhof Spandau
🇩🇪Spandau, Berlin, Germany
Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair
🇩🇪Bad Homburg, Hessen, Germany
Cardioangiologisches Centrum Bethanien
🇩🇪Frankfurt, Hessen, Germany
Klinikum Bielefeld Mitte
🇩🇪Bielefeld, Nordrhein-Westfalen, Germany
SMO.MD GmbH
🇩🇪Magdeburg, Sachsen-Anhalt, Germany
Kardiologische Praxen im Spreebogen
🇩🇪Berlin, Germany
Cardiologicum Hamburg
🇩🇪Hamburg, Germany
Sapporo Medical University Hospital
🇯🇵Sapporo, Hokkaido, 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, 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, Noord-Brabant, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Overijssel, Netherlands
Saxenburgh Medisch Centrum
🇳🇱Hardenberg, Overijssel, Netherlands
Groene Hart Ziekenhuis
🇳🇱Gouda, Zuid-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
🇷🇴Pitești, Argeș, Romania
C.M.D.T.A. Neomed
🇷🇴Brasov, Brașov, 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, Maramureș, Romania
Cardiomed
🇷🇴Târgu Mureș, Mureș, Romania
Private Practice - Dr. Cristian Podoleanu
🇷🇴Târgu-Mureș, Mureș, Romania
Centrul Medical Medicalis
🇷🇴Timisoara, Timiș, Romania
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
🇪🇸Sevilla, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain