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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

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.

AlabamaSEC Clinical Research LLC, Andalusia
Heart Center Research Llc, Huntsville
Mobile Heart Specialists, Mobile
ArizonaMercy Gilbert Medical Center, Gilbert
Clinical Research Inst of Arizona, Sun City West
Eclipse Clinical Research, Tucson
ArkansasCardiology and Medicine Clinic PA, Little Rock
CaliforniaCardiovascular 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
ColoradoUniv Of Color Anschutz Med Center, Aurora
ConnecticutBridgeport Hospital, Bridgeport
Hartford Hospital, Hartford
Chase Medical Research LLC, Waterbury
FloridaExcel 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
GeorgiaEmory University, Atlanta
Cardiovascular Consultants of S GA, Thomasville
IllinoisRush University Medical Center, Chicago
Advocate Lutheran General Childrens Hospital, Park Ridge
IndianaKrannert Institute of Cardiology, Indianapolis
KansasUniversity of Kansas Hospital, Kansas City
Cotton O Neil Clinical Res Center, Topeka
LouisianaLouisiana 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
MaineMaine Health Cardiology, Scarborough
MarylandJohns 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
MassachusettsMGH, Boston
MichiganHenry Ford Hospital, Detroit
AA Medical Research Center, Flint
Metro Health Univ of MI Health, Wyoming
MississippiBelzoni Clinical Research, Belzoni
Stern Cardiovascular Foundation Inc, Southaven
MissouriStudyMetrix Research, City of Saint Peters
Mercy Hospital St Louis, St Louis
Washington Univ School Of Medicine, St Louis
New HampshireDartmouth Hitchcock Medical Center, Lebanon
New JerseyThe Valley Hospital, Ridgewood
Overlook Medical Center, Summit
New YorkNorthwell 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 CarolinaNovant 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
OhioAkron Hospital Summa Health System, Akron
Aultman Hospital, Canton
Cleveland Clinic Foundation, Cleveland
Rama Research LLC, Marion
PennsylvaniaLancaster General Health, Lancaster
Perelman School of Medicine, Philadelphia
Allegheny General Hospital, Pittsburgh
TennesseeThe Stern Cardiovascular Foundation, Germantown
Apex Cardiology Research Associates of Jackson, Jackson
Vanderbilt Univ Medi Cen, Nashville
Cardiovascular Res of Knoxville LLC, Powell
TexasNorth 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
UtahProgressive Clinical Research, Bountiful
Intermountain Medical Center, Murray
The University of Utah, Salt Lake City
VirginiaInova Fairfax Hospital, Falls Church
Virginia Heart, Falls Church
Carient Heart and Vascular, Manassas
Dominion Medical Associates, Richmond
WashingtonHarborview Medical Center, Seattle
Swedish Medical Center-Cardiovascular Research, Seattle
Univ of Washington Medical Center, Seattle
West VirginiaWest Virginia University Hospital, Morgantown
WisconsinSt 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.