Cardiovascular Disease and Lipoprotein(a)Phase 3NCT07517263
An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
A Phase 3 study testing Pelacarsen (TQJ230) in people with Cardiovascular Disease and Lipoprotein(a), run by Novartis Pharmaceuticals at 646 sites in 40 countries.
Trial summary
This open-label extension study provides post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301). Study has been terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiovascular Disease and Lipoprotein(a)
- What is being tested?
- Pelacarsen (TQJ230)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,700 participants
- Where
- 646 sitesin 40 countries
- Study dates
- 11 May 2026to 9 Jan 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
- Participants who have completed the parent study EOS visit while still on assigned investigational product.
Who cannot join
- Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.
- Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5.
- Participants are receiving another investigational drug or device before the open-label treatment period.
- Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
646 sites in 40 countries.
646 sites in 40 countries
United States120 sites
Akron Hospital Summa Health System
Akron, Ohio, 44309
SEC Clinical Research LLC
Andalusia, Alabama, 36420
Piedmont Heart Institute
Atlanta, Georgia, 30309
Emory University
Atlanta, Georgia, 30322
Univ Of Color Anschutz Med Center
Aurora, Colorado, 80045
University of Maryland
Baltimore, Maryland, 21201
Sinai Ct for Throm Res and Drug Dev
Baltimore, Maryland, 21209
Johns Hopkins Univ School of Med
Baltimore, Maryland, 21287
Belzoni Clinical Research
Belzoni, Mississippi, 39038
Cardiovascular Res Found
Beverly Hills, California, 90210
National Heart Institute
Beverly Hills, California, 90211
Excel Medical Clinical Trials LLC
Boca Raton, Florida, 33434
MGH
Boston, Massachusetts, 02114-2696
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts, 02115
Progressive Clinical Research
Bountiful, Utah, 84010
Bay Area Cardiology Assoc
Brandon, Florida, 33511
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Aultman Hospital
Canton, Ohio, 44710
Novant Health Heart Vas Inst
Charlotte, North Carolina, 28204
Rush University Medical Center
Chicago, Illinois, 60612
Lindner Ctr At The Christ Hosp
Cincinnati, Ohio, 45219
StudyMetrix Research
City of Saint Peters, Missouri, 63303
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Johns Hopkins University
Columbia, Maryland, 21044
Ohio State University
Columbus, Ohio, 43210
Valley Clinical Trials Inc
Covina, California, 91723
Cardiovascular Associates Research
Covington, Louisiana, 70433
Louisiana Heart Center Research
Covington, Louisiana, 70433
Soltero Cardiovascular Research Center
Dallas, Texas, 75226
North Texas Endocrine Center
Dallas, Texas, 75231
SW Family Medicine Associates
Dallas, Texas, 75235
Wayne State University
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Virginia Heart
Falls Church, Virginia, 22042
AA Medical Research Center
Flint, Michigan, 48504
Anderson Medical Research
Ft. Washington, Maryland, 20744
The Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297
Medication Management LLC
Greensboro, North Carolina, 27405
Hartford Hospital
Hartford, Connecticut, 06102
CV Institute of the South
Houma, Louisiana, 70360
Baylor College Of Medicine
Houston, Texas, 77030
Diabetes Lipid Management Center
Huntington Beach, California, 92648
Heart Center Research Llc
Huntsville, Alabama, 35801
Krannert Institute of Cardiology
Indianapolis, Indiana, 46202-4800
Uni Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242
University of Calif Irvine Med Cntr
Irvine, California, 92660
Apex Cardiology Research Associates of Jackson
Jackson, Tennessee, 38301
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Western Michigan University
Kalamazoo, Michigan, 49008
University of Kansas Hospital
Kansas City, Kansas, 66160
Lancaster General Health
Lancaster, Pennsylvania, 17603
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Cardiology and Medicine Clinic PA
Little Rock, Arkansas, 72204
Memorial Care Health System
Long Beach, California, 90806
Keck Medical Center USC
Los Angeles, California, 90033
Carient Heart and Vascular
Manassas, Virginia, 20109
Northwell Health
Manhasset, New York, 11030
Saint Johns Hospital
Maplewood, Minnesota, 55109
Rama Research LLC
Marion, Ohio, 43302
Grace Research
Marshall, Texas, 75670
Omega Clinical Research
Metairie, Louisiana, 70006
St Luke s Medical Center Aurora
Milwaukee, Wisconsin, 53215
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
University Of Minnesota
Minneapolis, Minnesota, 55455
Mobile Heart Specialists
Mobile, Alabama, 36608
West Virginia University Hospital
Morgantown, West Virginia, 26506
Intermountain Medical Center
Murray, Utah, 84107
Advanced Research for Health Improvement LLC
Naples, Florida, 34102
Vanderbilt Univ Medi Cen
Nashville, Tennessee, 37232
Tulane Center for Clinical Research
New Orleans, Louisiana, 70112
Weill Cornell Medical Center
New York, New York, 10021
Icahn School of Med at Mt Sinai
New York, New York, 10029
Lenox Hill Hospital
New York, New York, 43210
Valley Clinical Trials
Northridge, California, 91325
Quality Clinical Research
Omaha, Nebraska, 68114
CV Ins of the South
Opelousas, Louisiana, 70570
Stanford University Medical Center
Palo Alto, California, 94304
Advocate Lutheran General Childrens Hospital
Park Ridge, Illinois, 60068
McLaren Ctr Research Innovation
Petoskey, Michigan, 49770
Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Peace River Cardiovascular Center
Port Charlotte, Florida, 33952
Progressive Medical Research
Port Orange, Florida, 32127
Cardiovascular Res of Knoxville LLC
Powell, Tennessee, 37849
Accellacare US Inc
Raleigh, North Carolina, 27609
Monument Health Clinical Research
Rapid City, South Dakota, 57701
Dominion Medical Associates
Richmond, Virginia, 23219
The Valley Hospital
Ridgewood, New Jersey, 07450
Northwell Health Physician Peconic
Riverhead, New York, 11901
Adventist HealthCare Shady Grove Medical Center
Rockville, Maryland, 20850
Central Michigan University
Saginaw, Michigan, 48601
East Coast Inst for Research LLC
Saint Augustine, Florida, 32086
The University of Utah
Salt Lake City, Utah, 84132-0001
University of California San Diego
San Diego, California, 92103
UCSF
San Francisco, California, 94115
Maine Health Cardiology
Scarborough, Maine, 04074
Harborview Medical Center
Seattle, Washington, 98104
Swedish Medical Center-Cardiovascular Research
Seattle, Washington, 98122
Univ of Washington Medical Center
Seattle, Washington, 98195
Grace Research Llc
Shreveport, Louisiana, 71105
Louisiana Heart Center Research
Slidell, Louisiana, 70458
Stern Cardiovascular Foundation Inc
Southaven, Mississippi, 38671
Washington Univ School Of Medicine
St Louis, Missouri, 63110
Mercy Hospital St Louis
St Louis, Missouri, 63141
Manshadi Heart Institute
Stockton, California, 95204
Overlook Medical Center
Summit, New Jersey, 07901
Clinical Research Inst of Arizona
Sun City West, Arizona, 85375
Cardiovascular Consultants of S GA
Thomasville, Georgia, 31792
Northwest Houston Clinical Research PLLC
Tomball, Texas, 77375
Cotton O Neil Clinical Res Center
Topeka, Kansas, 66606
Eclipse Clinical Research
Tucson, Arizona, 85745
Chase Medical Research LLC
Waterbury, Connecticut, 06708
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449
Interv Cardiology Med Grp
West Hills, California, 91307
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
Metro Health Univ of MI Health
Wyoming, Michigan, 49519
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, 19067
Southern Clinical Research
Zachary, Louisiana, 70791
Germany52 sites
Novartis Investigative Site
Aachen, 52074
Novartis Investigative Site
Bad Homburg, 61348
Novartis Investigative Site
Bad Krozingen, 79189
Novartis Investigative Site
Bad Oeynhausen, 32545
Novartis Investigative Site
Bamberg, 96049
Novartis Investigative Site
Berlin, 10367
Novartis Investigative Site
Berlin, 10559
Novartis Investigative Site
Berlin, 10787
Novartis Investigative Site
Berlin, 10789
Novartis Investigative Site
Berlin, 13347
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Bielefeld, 33604
Novartis Investigative Site
Chemnitz, Saxony, 09113
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50733
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937
Novartis Investigative Site
Dessau, 06846
Novartis Investigative Site
Dortmund, 44137
Novartis Investigative Site
Dresden, Saxony, 01099
Novartis Investigative Site
Dresden, Saxony, 01307
Novartis Investigative Site
Dresden, 01069
Novartis Investigative Site
Dresden, 01277
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Essen, North Rhine-Westphalia, 45355
Novartis Investigative Site
Essen, 45277
Novartis Investigative Site
Essen, 45355
Novartis Investigative Site
Essen, 45359
Novartis Investigative Site
Frankfurt am Main, Hesse, 60590
Novartis Investigative Site
Frankfurt am Main, Hesse, 60594
Novartis Investigative Site
Gelnhausen, 63571
Novartis Investigative Site
Hamburg, 22041
Novartis Investigative Site
Hamburg, 22607
Novartis Investigative Site
Hanover, Lower Saxony, 30159
Novartis Investigative Site
Jena, Thuringia, 07740
Novartis Investigative Site
Kassel, 34121
Novartis Investigative Site
Leipzig, Saxony, 04103
Novartis Investigative Site
Löhne, North Rhine-Westphalia, 32584
Novartis Investigative Site
Lüneburg, 21339
Novartis Investigative Site
Magdeburg, 39120
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, 68305
Novartis Investigative Site
Mannheim, 68165
Novartis Investigative Site
Meissen, 01662
Novartis Investigative Site
Muehldorf Am Inn, Bavaria, 84453
Novartis Investigative Site
München, 80636
Novartis Investigative Site
Munich, Bavaria, 81377
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Potsdam, 14471
Novartis Investigative Site
Rüdersdorf, 15562
Novartis Investigative Site
Saint Ingbert, Saarland, 66386
Novartis Investigative Site
Ulm, 89077
Novartis Investigative Site
Warendorf, 48231
Novartis Investigative Site
Weiden in Der Oberpfalz, Bavaria, 92637
Novartis Investigative Site
Wittenberg, Saxony-Anhalt, 06886
China36 sites
Novartis Investigative Site
Baotou, Inner Mongolia, 014040
Novartis Investigative Site
Beijing, Beijing Municipality, 100013
Novartis Investigative Site
Beijing, 100050
Novartis Investigative Site
Beijing, 100191
Novartis Investigative Site
Beijing, 100730
Novartis Investigative Site
Changchun, Jilin, 130021
Novartis Investigative Site
Changsha, Hunan, 410003
Novartis Investigative Site
Changsha, Hunan, 410008
Novartis Investigative Site
Changsha, Hunan, 410011
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Dalian, Liaoning, 116011
Novartis Investigative Site
Foshan, Guangdong, 528000
Novartis Investigative Site
Guangzhou, Guangdong, 510080
Novartis Investigative Site
Hangzhou, Zhejiang, 310014
Novartis Investigative Site
Hangzhou, Zhejiang, 310016
Novartis Investigative Site
Harbin, Heilongjiang, 150000
Novartis Investigative Site
Jinan, Shandong, 250013
Novartis Investigative Site
Lanzhou, Gansu, 730030
Novartis Investigative Site
Nanjing, Jiangsu, 210009
Novartis Investigative Site
Nanjing, Jiangsu, 210029
Novartis Investigative Site
Nanjing, Jiangsu, 211166
Novartis Investigative Site
Shanghai, 200025
Novartis Investigative Site
Shanghai, 200040
Novartis Investigative Site
Shanghai, 200065
Novartis Investigative Site
Shanghai, 200120
Novartis Investigative Site
Shenyang, Liaoning, 110004
Novartis Investigative Site
Shenyang, Liaoning, 110016
Novartis Investigative Site
Suzhou, Jiangsu, 215004
Novartis Investigative Site
Tianjin, 030045
Novartis Investigative Site
Tianjin, 300052
Novartis Investigative Site
Tianjin, 300121
Novartis Investigative Site
Ürümqi, Xinjiang, 830054
Novartis Investigative Site
Wenzhou, Zhejiang, 325000
Novartis Investigative Site
Xiamen, 361004
Novartis Investigative Site
Xian, Shanxi, 710061
Novartis Investigative Site
Xuzhou, Jiangsu, 221003
United Kingdom36 sites
Novartis Investigative Site
Birmingham, B9 5SS
Novartis Investigative Site
Bristol, BS2 8HW
Novartis Investigative Site
Bromwich, B71 4HJ
Novartis Investigative Site
Cardiff, Wales, CF5 4AD
Novartis Investigative Site
Cardiff, CF64 2XX
Novartis Investigative Site
Chertsey, Surrey, KT16 0PZ
Novartis Investigative Site
Chesterfield, S40 4AA
Novartis Investigative Site
Chichester, West Sussex, PO19 6SE
Novartis Investigative Site
Dorchester, Dorset, DT1 2JY
Novartis Investigative Site
Edinburgh, EH16 4SA
Novartis Investigative Site
Glasgow, G20 7BE
Novartis Investigative Site
Harrow, Middlesex, HA1 3UJ
Novartis Investigative Site
Leicester, LE3 9QP
Novartis Investigative Site
Liverpool, L7 8XP
Novartis Investigative Site
London, GBR, EC1M 6BQ
Novartis Investigative Site
London, Greater London, EN3 4GS
Novartis Investigative Site
London, W12 0HS
Novartis Investigative Site
Londonderry, BT47 6SB
Novartis Investigative Site
Manchester, M13 9WL
Novartis Investigative Site
Middlesbrough, TS4 3BW
Novartis Investigative Site
Middlesex, UB9 6JH
Novartis Investigative Site
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Novartis Investigative Site
Newport, NP20 2UB
Novartis Investigative Site
Norwich, NR4 7UY
Novartis Investigative Site
Plymouth, PL6 8DH
Novartis Investigative Site
Portadown, Nothern Ireland, BT63 5QQ
Novartis Investigative Site
Preston, Lancashire, PR2 9QB
Novartis Investigative Site
Rhyl, LL18 5UJ
Novartis Investigative Site
Rochdale, North Manchester, OL11 4AU
Novartis Investigative Site
Sheffield, S5 7AU
Novartis Investigative Site
Sunderland, Tyne and Wear, SR4 7TP
Novartis Investigative Site
Swansea, SA2 8QA
Novartis Investigative Site
Taunton, Somerset, TA1 5DA
Novartis Investigative Site
Tyne and Wear, NE29 8NH
Novartis Investigative Site
Wiltshire, SN15 2SB
Novartis Investigative Site
Wrexham, LL13 7TD
Russia34 sites
Novartis Investigative Site
Chelyabinsk, 454047
Novartis Investigative Site
Ivanovo, 153012
Novartis Investigative Site
Izhevsk, 426061
Novartis Investigative Site
Kemerovo, 650002
Novartis Investigative Site
Kirov, 610035
Novartis Investigative Site
Krasnodar, 350086
Novartis Investigative Site
Moscow, 101990
Novartis Investigative Site
Moscow, 117198
Novartis Investigative Site
Moscow, 117997
Novartis Investigative Site
Moscow, 121552
Novartis Investigative Site
Moscow, 127473
Novartis Investigative Site
Moscow, 141060
Novartis Investigative Site
Novosibirsk, 630090
Novartis Investigative Site
Perm, 614097
Novartis Investigative Site
Rostov-on-Don, 344022
Novartis Investigative Site
Ryazan, 390039
Novartis Investigative Site
Saint Petersburg, Russia, 198328
Novartis Investigative Site
Saint Petersburg, 191015
Novartis Investigative Site
Saint Petersburg, 194354
Novartis Investigative Site
Saint Petersburg, 195197
Novartis Investigative Site
Saint Petersburg, 196143
Novartis Investigative Site
Saint Petersburg, 197341
Novartis Investigative Site
Saint Petersburg, 199178
Novartis Investigative Site
Samara, 443070
Novartis Investigative Site
Saratov, 410012
Novartis Investigative Site
Saratov, 410028
Novartis Investigative Site
Sochy, 354002
Novartis Investigative Site
Tomsk, 634009
Novartis Investigative Site
Ulyanovsk, 432063
Novartis Investigative Site
Vsevolozhsk, 188643
Novartis Investigative Site
Yaroslavl, 150062
Novartis Investigative Site
Yekaterinburg, 620028
Novartis Investigative Site
Yekaterinburg, 620137
Novartis Investigative Site
Yekaterinburg, 620144
Czechia33 sites
Novartis Investigative Site
Brandýs nad Labem, 250 01
Novartis Investigative Site
Brno, 602 00
Novartis Investigative Site
Brno, 625 00
Novartis Investigative Site
Broumov, 550 01
Novartis Investigative Site
Český Krumlov, 381 01
Novartis Investigative Site
Chlumec nad Cidlinou, 503 51
Novartis Investigative Site
CZE, 110 00
Novartis Investigative Site
Hlučín, 748 01
Novartis Investigative Site
Hodonín, 695 01
Novartis Investigative Site
Jihlava, 586 01
Novartis Investigative Site
Kolín, 280 20
Novartis Investigative Site
Kroměříž, Czech Republic, 767 55
Novartis Investigative Site
Liberec, 460 01
Novartis Investigative Site
Liberec, 460 05
Novartis Investigative Site
Louny, Czech Republic, 440 01
Novartis Investigative Site
Mariánské Lázně, 353 01
Novartis Investigative Site
Mělník, 276 01
Novartis Investigative Site
Most, 434 01
Novartis Investigative Site
Olomouc, 779 00
Novartis Investigative Site
Ostrava, Czech Republic, 725 27
Novartis Investigative Site
Ostrava, Zabreh, 700 30
Novartis Investigative Site
Ostrava, 700 30
Novartis Investigative Site
Pardubice, 532 03
Novartis Investigative Site
Polička, 57201
Novartis Investigative Site
Prague, 110 00
Novartis Investigative Site
Prague, 128 08
Novartis Investigative Site
Slaný, 274 01
Novartis Investigative Site
Třebíč, 674 01
Novartis Investigative Site
Trutnov, 460 63
Novartis Investigative Site
Uherské Hradiště, 686 01
Novartis Investigative Site
Ústí nad Labem, Czech Republic, 400 01
Novartis Investigative Site
Valašské Meziříčí, 75742
Novartis Investigative Site
Zlín, 760 01
India32 sites
Novartis Investigative Site
Ahmedabad, Gujarat, 380054
Novartis Investigative Site
Ahmedabad, Gujarat, 380060
Novartis Investigative Site
Belagavi, Karnataka, 590010
Novartis Investigative Site
Bikaner, Rajasthan, 334003
Novartis Investigative Site
Chennai, Tamil Nadu, 600006
Novartis Investigative Site
Coimbatore, Tamil Nadu, 641009
Novartis Investigative Site
Coimbatore, Tamil Nadu, 641037
Novartis Investigative Site
Dehradun, Uttarakhand, 248001
Novartis Investigative Site
Ghaziabad, Uttar Pradesh, 201012
Novartis Investigative Site
Guntur, Andhra Pradesh, 522001
Novartis Investigative Site
Hyderabad, Telangana, 500034
Novartis Investigative Site
Hyderabad, Telangana, 500082
Novartis Investigative Site
Kochi, Kerala, 682018
Novartis Investigative Site
Kochi, Kerala, 682027
Novartis Investigative Site
Kochi, Kerala, 682041
Novartis Investigative Site
Lucknow, Uttar Pradesh, 226003
Novartis Investigative Site
Mangalore, Karnataka, 575018
Novartis Investigative Site
Manipal, Karnataka, 576104
Novartis Investigative Site
Mysore, 570015
Novartis Investigative Site
Nagpur, Maharashtra, 440008
Novartis Investigative Site
Nagpur, Maharashtra, 440012
Novartis Investigative Site
Nagpur, Maharashtra, 440025
Novartis Investigative Site
Nagpur, Maharashtra, 440033
Novartis Investigative Site
Nashik, Maharashtra, 422005
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110060
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110075
Novartis Investigative Site
New Delhi, 110025
Novartis Investigative Site
Pune, Maharashtra, 411004
Novartis Investigative Site
Pune, Maharashtra, 411028
Novartis Investigative Site
Pune, Maharashtra, 411045
Novartis Investigative Site
Secunderabad, Telangana, 500003
Novartis Investigative Site
Vadodara, Gujarat, 390022
Japan27 sites
Novartis Investigative Site
Asahi, Chiba, 2892511
Novartis Investigative Site
Bunkyo Ku, Tokyo, 1138431
Novartis Investigative Site
Chuo Ku, Tokyo, 1048560
Novartis Investigative Site
Chuo-ku, Tokyo, 1030027
Novartis Investigative Site
Funabashi, Chiba, 2738588
Novartis Investigative Site
Hachiōji, Tokyo, 1920918
Novartis Investigative Site
Hirosaki, Aomori, 0368563
Novartis Investigative Site
Ishikawa, 9208641
Novartis Investigative Site
Itabashi-ku, Tokyo, 1738610
Novartis Investigative Site
Kawasaki, Kanagawa, 2120021
Novartis Investigative Site
Kitakyushu, Fukuoka, 8028555
Novartis Investigative Site
Komatsu, Ishikawa-ken, 9230961
Novartis Investigative Site
Kure, Hiroshima, 7370023
Novartis Investigative Site
Matsudo, Chiba, 2702251
Novartis Investigative Site
Miyhazaki, Miyazaki, 8802102
Novartis Investigative Site
Nagoya, Aichi-ken, 4538511
Novartis Investigative Site
Ōgaki, Gifu, 5038502
Novartis Investigative Site
Ōmihachiman, Shiga, 5230082
Novartis Investigative Site
Osaka, Osaka, 5438922
Novartis Investigative Site
Ōta-ku, Tokyo, 1438541
Novartis Investigative Site
Sagamihara, Kanagawa, 2520375
Novartis Investigative Site
Sayama, Saitama, 3501305
Novartis Investigative Site
Sendai, Miyagi, 9810914
Novartis Investigative Site
Seto, Aichi-ken, 4898642
Novartis Investigative Site
Takamatsu, Kagawa-ken, 7608557
Novartis Investigative Site
Tsuchiura, Ibaraki, 3000028
Novartis Investigative Site
Yokohama, Kanagawa, 2320024
Brazil26 sites
Novartis Investigative Site
Aracaju, Sergipe, 49055-530
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30150-270
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30150-320
Novartis Investigative Site
Blumenau, Santa Catarina, 89020-430
Novartis Investigative Site
Brasília, Federal District, 70390-700
Novartis Investigative Site
Campinas, São Paulo, 13060-080
Novartis Investigative Site
Campinas, São Paulo, 13092133
Novartis Investigative Site
Canoas, Rio Grande do Sul, 92425-900
Novartis Investigative Site
Curitiba, Paraná, 80730-150
Novartis Investigative Site
Goiânia, Goiás, 74605-020
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90160-093
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90880-480
Novartis Investigative Site
Ribeirão Preto, São Paulo, 14026-020
Novartis Investigative Site
Rio de Janeiro, 20241-180
Novartis Investigative Site
Salvador, Estado de Bahia, 40170-130
Novartis Investigative Site
Santo André, São Paulo, 09060-870
Novartis Investigative Site
Santo André, São Paulo, 09090-790
Novartis Investigative Site
Sao Jose Rio Preto, São Paulo, 15015-750
Novartis Investigative Site
Sao Jose Rio Preto, São Paulo, 15090-000
Novartis Investigative Site
São Paulo, São Paulo, 01323-000
Novartis Investigative Site
São Paulo, São Paulo, 04005-003
Novartis Investigative Site
São Paulo, São Paulo, 04266-010
Novartis Investigative Site
São Paulo, São Paulo, 05403-000
Novartis Investigative Site
São Paulo, São Paulo, 05403-900
Novartis Investigative Site
Uberlândia, Minas Gerais, 38400-500
Novartis Investigative Site
Vitória, Espírito Santo, 29055-450
Netherlands22 sites
Novartis Investigative Site
Alkmaar, North Holland, 1815 JD
Novartis Investigative Site
Amersfoort, 3813 TZ
Novartis Investigative Site
Amsterdam, North Holland, 1090 HM
Novartis Investigative Site
Amsterdam, North Holland, 1105 AZ
Novartis Investigative Site
Apeldoorn, Gelderland, 7334 DZ
Novartis Investigative Site
Arnhem, Gelderland, 6815 AD
Novartis Investigative Site
Deventer, Overijssel, 7416 SE
Novartis Investigative Site
Gouda, 2803 HH
Novartis Investigative Site
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About this study
Official title: A Single Arm, Multicenter, Open-label Extension (OLE) Trial to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Participants Who Completed the Parent Lp(a)HORIZON Trial
This open-label extension study provides post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301). Study has been terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint.
Read the detailed description
This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in participants with established cardiovascular disease and elevated Lp(a) who completed the parent study (CTQJ230A12301).
- Being tested
- Pelacarsen (TQJ230)
- Keywords
- Lipoprotein(a),, Lp(a),, cardiovascular disease,, CVD,, myocardial infarction,, stroke,, OLE,, pelacarsen,, open-label
- Medical subject headings
- Cardiovascular Diseases, Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelacarsen (TQJ230)Drug
Also called TQJ230
pelacarsen 80mg s.c. monthly
| Study group | Role | What they receive |
|---|---|---|
| Pelacarsen (TQJ230) | Experimental | open-label pelacarsen 80mg Receives: Drug: Pelacarsen (TQJ230) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse events
Number of participants with Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of special interest, including abnormal laboratory evaluations and vital signs. Number of participants discontinuing due to treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) will also be presented.
Measured: Up to 36 months
Secondary outcomes (7)
Time to first occurrence of 4 Point-Major Cardiovascular Event (4P-MACE) from parent study baseline
Time to first occurrence of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) from the beginning of the parent study will be presented
Measured: Up to 36 months
Time to the first occurrence of 4P-MACE from open-label extension (OLE) study baseline
Time to first occurrence of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) from the beginning of the OLE study will be presented
Measured: Up to 36 months
Cumulative number of 4P-MACE over time from OLE study baseline
Cumulative number of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) over time from the beginning of the OLE study will be presented
Measured: Up to 36 months
Cumulative number of 4P-MACE over time from parent study baseline
Cumulative number of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) over time from the beginning of the parent study will be presented
Measured: Up to 36 months
Observed value of Lipoprotein(a) (Lp(a))
Samples for Lp(a) assessment will be collected at the defined time points, analyzed and values reported.
Measured: Baseline, Month 3, Month 12, Month 24, Month 36
Change in Lp(a) compared to baseline of the OLE study
Samples for Lp(a) assessment will be collected at defined time points and change will be calculated against baseline of the OLE study.
Measured: Baseline, Month 3, Month 12, Month 24, Month 36
Change in Lp(a) compared to baseline of the parent study
Samples for Lp(a) assessment will be collected at defined time points and change will be calculated against baseline of the parent study.
Measured: Baseline, Month 3, Month 12, Month 24, Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start11 May 2026
- Primary completion9 Jan 2030 (estimated)
- Study completion9 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease and Lipoprotein(a)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label extension (OLE) study
- Masking
- None (open label)
- Enrolment
- 5,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517263
- Sponsor's protocol ID
- CTQJ230A12301E1
- Other IDs
- 2024-519870-38-00
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Multicenter, Open-label Extension (OLE) Trial to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Participants Who Completed the Parent Lp(a)HORIZON Trial
- ClinicalTrials.gov ID
- NCT07517263
- Acronym / sponsor ID
- CTQJ230A12301E1
- Keywords
- Lipoprotein(a),, Lp(a),, cardiovascular disease,, CVD,, myocardial infarction,, stroke,, OLE,, pelacarsen,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,700 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 May 2026 (actual)
- Primary completion
- 9 Jan 2030 (estimated)
- Study completion
- 9 Jan 2030 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label extension study provides post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301). Study has been terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint.
Detailed description
This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in participants with established cardiovascular disease and elevated Lp(a) who completed the parent study (CTQJ230A12301).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label extension (OLE) study
| Arm | Type | Receives |
|---|---|---|
| Pelacarsen (TQJ230) | Experimental | Drug: Pelacarsen (TQJ230)open-label pelacarsen 80mg |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
- Participants who have completed the parent study EOS visit while still on assigned investigational product.
Key exclusion criteria (5 listed)
- Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.
- Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5.
- Participants are receiving another investigational drug or device before the open-label treatment period.
- Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.
- Other protocol-defined inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelacarsen (TQJ230)Also: TQJ230pelacarsen 80mg s.c. monthly | Drug | Pelacarsen (TQJ230) |
Primary outcome
Number of participants with Adverse events
Time frame: Up to 36 months
Number of participants with Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of special interest, including abnormal laboratory evaluations and vital signs. Number of participants discontinuing due to treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) will also be presented.
7 secondary outcomes
Time to first occurrence of 4 Point-Major Cardiovascular Event (4P-MACE) from parent study baseline
Time frame: Up to 36 months
Time to the first occurrence of 4P-MACE from open-label extension (OLE) study baseline
Time frame: Up to 36 months
Cumulative number of 4P-MACE over time from OLE study baseline
Time frame: Up to 36 months
Cumulative number of 4P-MACE over time from parent study baseline
Time frame: Up to 36 months
Observed value of Lipoprotein(a) (Lp(a))
Time frame: Baseline, Month 3, Month 12, Month 24, Month 36
Change in Lp(a) compared to baseline of the OLE study
Time frame: Baseline, Month 3, Month 12, Month 24, Month 36
Change in Lp(a) compared to baseline of the parent study
Time frame: Baseline, Month 3, Month 12, Month 24, Month 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Related trials for Cardiovascular Disease and Lipoprotein(a)
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Active, not recruitingPhase 2
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Otherwise Healthy Individuals With Systolic Blood Pressure (SBP) From 110 to 139 mmHg and Low-density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
646 sites in 40 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pelacarsen (TQJ230) in people with Cardiovascular Disease and Lipoprotein(a), run by Novartis Pharmaceuticals at 646 sites in 40 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 646 sites in United States, Germany, China, United Kingdom, Russia and 35 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse events (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.