Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
Launched by NOVARTIS PHARMACEUTICALS · Jan 22, 2019
Trial Information
Current as of May 23, 2025
Completed
Keywords
ClinConnect Summary
This study was an open label, long term extension study in subjects with atherosclerotic cardiovascular disease (ASCVD), ASCVD-risk equivalents (eg, diabetes and familial hypercholesterolemia), or heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C) despite maximum tolerated dose of LDL-C lowering therapies who have completed the inclisiran Phase II trial MDCO-PCS-16-01 (ORION-3; NCT03060577), or any of the following Phase III lipid lowering studies: MDCO-PCS-17-03 (ORION-9; NCT03397121), MDCO-PCS-17-04 (ORION-10; NCT03399370), or MDCO-P...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Completion on a previously qualifying inclisiran Phase II trial MDCO-PCS-16-01 (ORION-3), or Phase III lipid lowering ORION feeder study \[MDCO-PCS-17-03 (ORION-9), MDCO-PCS-17-4 (ORION-10), or MDCO-PCS-17-08 (ORION-11)\] meaning the subject received the last dose of study drug and completed the final study visit per applicable protocol.
- • 2. On current lipid-lowering therapies (such as a statin and/or ezetimibe) from previous study with no planned medication or dose change during study participation.
- • 3. Willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures.
- Exclusion Criteria:
- • 1. Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the subject at significant risk \[according to investigator's (or delegate's) judgment\] if he/she participates in the clinical study.
- • 2. An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.
- • 3. Severe concomitant noncardiovascular disease that carries the risk of reducing life expectancy to less than 3 years,
- • 4. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST), elevation \>3x the upper limit of normal (ULN), or total bilirubin (TBIL) elevation \>2x ULN at the last recorded visit in the feeder study prior to study entry visit.
- 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least one method of acceptable effective contraception (eg, oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device) for the entire duration of the study. Exemptions from this criterion:
- • 1. Women \>2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.
- • 2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.
- • 3. Women who are surgically sterilized at least 3 months prior to enrollment.
- • 6. Planned use of other investigational medicinal products other than inclisiran or devices during the course of the study.
- 7. Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to:
- • 1. Subjects who are unable to communicate or to cooperate with the investigator
- • 2. Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including subjects whose cooperation is doubtful due to drug abuse or alcohol dependency)
- • 3. Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (eg, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study)
- • 4. Have any medical or surgical condition, which in the opinion of the investigator would put the subject at increased risk from participating in the study
- • 5. Persons directly involved in the conduct of the study.
- • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Foley, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Montgomery, Alabama, United States
Saraland, Alabama, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Surprise, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Beverly Hills, California, United States
Canoga Park, California, United States
Carlsbad, California, United States
El Cajon, California, United States
Los Angeles, California, United States
Northridge, California, United States
Northridge, California, United States
Sacramento, California, United States
San Ramon, California, United States
Santa Rosa, California, United States
Spring Valley, California, United States
Torrance, California, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Fleming Island, Florida, United States
Fort Lauderdale, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Miami Springs, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Pembroke Pines, Florida, United States
Pembroke Pines, Florida, United States
Pembroke Pines, Florida, United States
Pinellas Park, Florida, United States
Ponte Vedra, Florida, United States
Saint Augustine, Florida, United States
Saint Petersburg, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Dunwoody, Georgia, United States
Macon, Georgia, United States
Arlington Heights, Illinois, United States
Evanston, Illinois, United States
Indianapolis, Indiana, United States
Valparaiso, Indiana, United States
West Des Moines, Iowa, United States
Hutchinson, Kansas, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Owensboro, Kentucky, United States
Crowley, Louisiana, United States
Lake Charles, Louisiana, United States
Monroe, Louisiana, United States
Flint, Michigan, United States
Grandville, Michigan, United States
Sterling Heights, Michigan, United States
Troy, Michigan, United States
Edina, Minnesota, United States
Saint Louis, Missouri, United States
Saint Louis, Missouri, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Bridgewater, New Jersey, United States
Albany, New York, United States
Binghamton, New York, United States
Endwell, New York, United States
New Windsor, New York, United States
Poughkeepsie, New York, United States
Williamsville, New York, United States
Cary, North Carolina, United States
Greensboro, North Carolina, United States
Mooresville, North Carolina, United States
Shelby, North Carolina, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Marion, Ohio, United States
Wyomissing, Pennsylvania, United States
Anderson, South Carolina, United States
Greer, South Carolina, United States
Greer, South Carolina, United States
Myrtle Beach, South Carolina, United States
Pelzer, South Carolina, United States
Rapid City, South Dakota, United States
Athens, Tennessee, United States
Kingsport, Tennessee, United States
Knoxville, Tennessee, United States
Amarillo, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Edinburg, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
New Braunfels, Texas, United States
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Schertz, Texas, United States
Shavano Park, Texas, United States
Tomball, Texas, United States
Layton, Utah, United States
Salt Lake City, Utah, United States
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Falls Church, Virginia, United States
Manassas, Virginia, United States
Midlothian, Virginia, United States
Richmond, Virginia, United States
Suffolk, Virginia, United States
Tacoma, Washington, United States
Frankfurt, , Germany
Heidelberg, , Germany
Mission Viejo, California, United States
Stanford, California, United States
Boca Raton, Florida, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Saint Paul, Minnesota, United States
Butte, Montana, United States
Las Vegas, Nevada, United States
Summit, New Jersey, United States
Warren, New Jersey, United States
Cincinnati, Ohio, United States
Knoxville, Tennessee, United States
Chicoutimi, Quebec, Canada
Montréal, Quebec, Canada
Québec, Quebec, Canada
Chomutov, , Czechia
Praha, , Czechia
Praha, , Czechia
Uherské Hradiště, , Czechia
Aalborg, Nordjylland, Denmark
Esbjerg, , Denmark
Herning, , Denmark
Hvidovre, , Denmark
Roskilde, , Denmark
Viborg, , Denmark
Berlin, , Germany
Bochum, , Germany
Heidelberg, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Hatvan, , Hungary
Zalaegerszeg, , Hungary
Amersfoort, , Netherlands
Amsterdam, , Netherlands
Goes, , Netherlands
Hoorn, , Netherlands
Utrecht, , Netherlands
Brzozowie, , Poland
Bydgoszcz, , Poland
Bydgoszcz, , Poland
Gdańsk, , Poland
Gdynia, , Poland
Katowice, , Poland
Katowice, , Poland
Kraków, , Poland
Kraków, , Poland
Lublin, , Poland
Poznań, , Poland
Ruda śląska, , Poland
Rzeszów, , Poland
Tarnów, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wrocław, , Poland
Wrocław, , Poland
Bellville, Cape Town, South Africa
Lyttelton, Cape Town, South Africa
Bloemfontein, Free State, South Africa
Johannesburg, Gauteng, South Africa
Kempton Park, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Witbank, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Kuilsrivier, Western Cape, South Africa
Paarl, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Córdoba, Andalucia, Spain
Zaragoza, Aragon, Spain
Barcelona, Cataluna, Spain
Barcelona, Cataluna, Spain
Reus, Cataluna, Spain
La Coruña, Galicia, Spain
Göteborg, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Cherkasy, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Zaporizhzhya, , Ukraine
úzhgorod, , Ukraine
Bollington, Cheshire, United Kingdom
Bury, , United Kingdom
Cheadle Hulme, , United Kingdom
Chorley, , United Kingdom
Cornwell, , United Kingdom
Derby, , United Kingdom
Edgbaston, , United Kingdom
Exeter, , United Kingdom
Glasgow, , United Kingdom
Hexham, , United Kingdom
Macclesfield, , United Kingdom
Manchester, , United Kingdom
Manchester, , United Kingdom
Manchester, , United Kingdom
Manchester, , United Kingdom
Plymouth, , United Kingdom
Reading, , United Kingdom
Sale, , United Kingdom
Sale, , United Kingdom
Stockton On Tees, , United Kingdom
Timperley, , United Kingdom
Wales, , United Kingdom
Waterloo, , United Kingdom
Patients applied
Trial Officials
Scott Wright, MD
Principal Investigator
Mayo Clinic
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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