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An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
RecruitingPhase 3
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
Who can join
Ages 18 to 100 · All sexes
Full eligibility criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
About the study
This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).
What is being tested
- Pelacarsen (TQJ230) (drug)
Sponsor: Novartis Pharmaceuticals · Participants: 5,700 · Started: May 11, 2026
Contact the study team
Official record on ClinicalTrials.gov — NCT07517263
Locations in the U.S.
| Alabama | SEC Clinical Research LLC, Andalusia Heart Center Research Llc, Huntsville Mobile Heart Specialists, Mobile |
| Arizona | Mercy Gilbert Medical Center, Gilbert Clinical Research Inst of Arizona, Sun City West Eclipse Clinical Research, Tucson |
| Arkansas | Cardiology and Medicine Clinic PA, Little Rock |
| California | Cardiovascular Res Found, Beverly Hills National Heart Institute, Beverly Hills Diabetes Lipid Management Center, Huntington Beach University of Calif Irvine Med Cntr, Irvine Memorial Care Health System, Long Beach Keck Medical Center USC, Los Angeles Stanford University Medical Center, Palo Alto University of California San Diego, San Diego UCSF, San Francisco Manshadi Heart Institute, Stockton |
| Colorado | Univ Of Color Anschutz Med Center, Aurora |
| Connecticut | Bridgeport Hospital, Bridgeport Hartford Hospital, Hartford Chase Medical Research LLC, Waterbury |
| Florida | Excel Medical Clinical Trials LLC, Boca Raton Bay Area Cardiology Assoc, Brandon Jacksonville Center for Clinical Research, Jacksonville Advanced Research for Health Improvement LLC, Naples Peace River Cardiovascular Center, Port Charlotte Progressive Medical Research, Port Orange East Coast Inst for Research LLC, Saint Augustine Cardiology Partners Clinical Research Institute, Wellington |
| Georgia | Emory University, Atlanta Cardiovascular Consultants of S GA, Thomasville |
| Illinois | Rush University Medical Center, Chicago Advocate Lutheran General Childrens Hospital, Park Ridge |
| Indiana | Krannert Institute of Cardiology, Indianapolis |
| Kansas | University of Kansas Hospital, Kansas City Cotton O Neil Clinical Res Center, Topeka |
| Louisiana | Louisiana Heart Center Research, Covington Louisiana Heart Center Research, Covington CV Institute of the South, Houma Omega Clinical Research, Metairie Tulane Center for Clinical Research, New Orleans CV Ins of the South, Opelousas Louisiana Heart Center Research, Slidell |
| Maine | Maine Health Cardiology, Scarborough |
| Maryland | Johns Hopkins Univ School of Med, Baltimore Sinai Ct for Throm Res and Drug Dev, Baltimore University of Maryland, Baltimore Johns Hopkins University, Columbia Anderson Medical Research, Ft. Washington Adventist HealthCare Shady Grove Medical Center, Rockville |
| Massachusetts | MGH, Boston |
| Michigan | Henry Ford Hospital, Detroit AA Medical Research Center, Flint Metro Health Univ of MI Health, Wyoming |
| Mississippi | Belzoni Clinical Research, Belzoni Stern Cardiovascular Foundation Inc, Southaven |
| Missouri | StudyMetrix Research, City of Saint Peters Mercy Hospital St Louis, St Louis Washington Univ School Of Medicine, St Louis |
| New Hampshire | Dartmouth Hitchcock Medical Center, Lebanon |
| New Jersey | The Valley Hospital, Ridgewood Overlook Medical Center, Summit |
| New York | Northwell Health, Manhasset Icahn School of Med at Mt Sinai, New York Lenox Hill Hospital, New York Weill Cornell Medical Center, New York Northwell Health Physician Peconic, Riverhead |
| North Carolina | Novant Health Heart Vas Inst, Charlotte Medication Management LLC, Greensboro Accellacare US Inc, Raleigh Wake Forest University Baptist Medical Center, Winston-Salem Wake Forest University Baptist Medical Center, Winston-Salem |
| Ohio | Akron Hospital Summa Health System, Akron Aultman Hospital, Canton Cleveland Clinic Foundation, Cleveland Rama Research LLC, Marion |
| Pennsylvania | Lancaster General Health, Lancaster Perelman School of Medicine, Philadelphia Allegheny General Hospital, Pittsburgh |
| Tennessee | The Stern Cardiovascular Foundation, Germantown Apex Cardiology Research Associates of Jackson, Jackson Vanderbilt Univ Medi Cen, Nashville Cardiovascular Res of Knoxville LLC, Powell |
| Texas | North Texas Endocrine Center, Dallas SW Family Medicine Associates, Dallas Soltero Cardiovascular Research Center, Dallas Baylor College Of Medicine, Houston Grace Research, Marshall Northwest Houston Clinical Research PLLC, Tomball |
| Utah | Progressive Clinical Research, Bountiful Intermountain Medical Center, Murray The University of Utah, Salt Lake City |
| Virginia | Inova Fairfax Hospital, Falls Church Virginia Heart, Falls Church Carient Heart and Vascular, Manassas Dominion Medical Associates, Richmond |
| Washington | Harborview Medical Center, Seattle Swedish Medical Center-Cardiovascular Research, Seattle Univ of Washington Medical Center, Seattle |
| West Virginia | West Virginia University Hospital, Morgantown |
| Wisconsin | St Luke s Medical Center Aurora, Milwaukee |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.