An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
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
2 other identifiers
interventional
5,700
36 countries
612
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2026
Typical duration for phase_3
612 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2026
CompletedFirst Posted
Study publicly available on registry
April 8, 2026
CompletedStudy Start
First participant enrolled
May 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 9, 2030
June 10, 2026
June 1, 2026
3.7 years
April 1, 2026
June 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 36 months
Secondary Outcomes (7)
Time to first occurrence of 4 Point-Major Cardiovascular Event (4P-MACE) from parent study baseline
Up to 36 months
Time to the first occurrence of 4P-MACE from open-label extension (OLE) study baseline
Up to 36 months
Cumulative number of 4P-MACE over time from OLE study baseline
Up to 36 months
Cumulative number of 4P-MACE over time from parent study baseline
Up to 36 months
Observed value of Lipoprotein(a) (Lp(a))
Baseline, Month 3, Month 12, Month 24, Month 36
- +2 more secondary outcomes
Study Arms (1)
Pelacarsen (TQJ230)
EXPERIMENTALopen-label pelacarsen 80mg
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (618)
SEC Clinical Research LLC
Andalusia, Alabama, 36420, United States
Heart Center Research Llc
Huntsville, Alabama, 35801, United States
Mobile Heart Specialists
Mobile, Alabama, 36608, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297, United States
Clinical Research Inst of Arizona
Sun City West, Arizona, 85375, United States
Eclipse Clinical Research
Tucson, Arizona, 85745, United States
Cardiology and Medicine Clinic PA
Little Rock, Arkansas, 72204, United States
Cardiovascular Res Found
Beverly Hills, California, 90210, United States
National Heart Institute
Beverly Hills, California, 90211, United States
Valley Clinical Trials Inc
Covina, California, 91723, United States
University of Calif Irvine Med Cntr
Irvine, California, 92660, United States
Keck Medical Center USC
Los Angeles, California, 90033, United States
Valley Clinical Trials
Northridge, California, 91325, United States
Stanford University Medical Center
Palo Alto, California, 94304, United States
UCSF
San Francisco, California, 94115, United States
Helping Hands Medical Associates INC
Santa Ana, California, 92704, United States
Manshadi Heart Institute
Stockton, California, 95204, United States
Interv Cardiology Med Grp
West Hills, California, 91307, United States
Univ Of Color Anschutz Med Center
Aurora, Colorado, 80045, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Chase Medical Research LLC
Waterbury, Connecticut, 06708, United States
Excel Medical Clinical Trials LLC
Boca Raton, Florida, 33434, United States
Bay Area Cardiology Assoc
Brandon, Florida, 33511, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Advanced Research for Health Improvement LLC
Naples, Florida, 34102, United States
Peace River Cardiovascular Center
Port Charlotte, Florida, 33952, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
East Coast Inst for Research LLC
Saint Augustine, Florida, 32086, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449, United States
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
Emory University
Atlanta, Georgia, 30322, United States
Cardiovascular Consultants of S GA
Thomasville, Georgia, 31792, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Krannert Institute of Cardiology
Indianapolis, Indiana, 46202 4800, United States
Uni Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
Cotton O Neil Clinical Res Center
Topeka, Kansas, 66606, United States
Cardiovascular Associates Research
Covington, Louisiana, 70433, United States
Louisiana Heart Center Research
Covington, Louisiana, 70433, United States
Louisiana Heart Center Research
Covington, Louisiana, 70433, United States
CV Institute of the South
Houma, Louisiana, 70360, United States
Horizon Research Grp
Lafayette, Louisiana, 70501, United States
Omega Clinical Research
Metairie, Louisiana, 70006, United States
Tulane Center for Clinical Research
New Orleans, Louisiana, 70112, United States
CV Ins of the South
Opelousas, Louisiana, 70570, United States
Grace Research Llc
Shreveport, Louisiana, 71105, United States
Louisiana Heart Center Research
Slidell, Louisiana, 70458, United States
Southern Clinical Research
Zachary, Louisiana, 70791, United States
Maine Health Cardiology
Scarborough, Maine, 04074, United States
Sinai Ct for Throm Res and Drug Dev
Baltimore, Maryland, 21209, United States
Johns Hopkins Univ School of Med
Baltimore, Maryland, 21287, United States
Johns Hopkins University
Columbia, Maryland, 21044, United States
Anderson Medical Research
Ft. Washington, Maryland, 20744, United States
Adventist HealthCare Shady Grove Medical Center
Rockville, Maryland, 20850, United States
MGH
Boston, Massachusetts, 02114 2696, United States
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts, 02115, United States
Wayne State University
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
AA Medical Research Center
Flint, Michigan, 48504, United States
Western Michigan University
Kalamazoo, Michigan, 49008, United States
McLaren Ctr Research Innovation
Petoskey, Michigan, 49770, United States
Central Michigan University
Saginaw, Michigan, 48601, United States
Metro Health Univ of MI Health
Wyoming, Michigan, 49519, United States
Saint Johns Hospital
Maplewood, Minnesota, 55109, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
University Of Minnesota
Minneapolis, Minnesota, 55455, United States
Belzoni Clinical Research
Belzoni, Mississippi, 39038, United States
Stern Cardiovascular Foundation Inc
Southaven, Mississippi, 38671, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Washington Univ School Of Medicine
St Louis, Missouri, 63110, United States
Quality Clinical Research
Omaha, Nebraska, 68114, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
Overlook Medical Center
Summit, New Jersey, 07901, United States
Northwell Health
Manhasset, New York, 11030, United States
Weill Cornell Medical Center
New York, New York, 10021, United States
Icahn School of Med at Mt Sinai
New York, New York, 10029, United States
Lenox Hill Hospital
New York, New York, 43210, United States
Northwell Health Physician Peconic
Riverhead, New York, 11901, United States
Novant Health Heart Vas Inst
Charlotte, North Carolina, 28204, United States
Medication Management LLC
Greensboro, North Carolina, 27405, United States
Accellacare US Inc
Raleigh, North Carolina, 27609, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Lindner Ctr At The Christ Hosp
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Rama Research LLC
Marion, Ohio, 43302, United States
Lancaster General Health
Lancaster, Pennsylvania, 17603, United States
Perelman School of Medicine
Philadelphia, Pennsylvania, 19104, United States
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, 19067, United States
Monument Health Clinical Research
Rapid City, South Dakota, 57701, United States
The Stern Cardiovascular Foundation
Germantown, Tennessee, 38138, United States
Apex Cardiology Research Associates of Jackson
Jackson, Tennessee, 38301, United States
Vanderbilt Univ Medi Cen
Nashville, Tennessee, 37232, United States
Cardiovascular Res of Knoxville LLC
Powell, Tennessee, 37849, United States
Soltero Cardiovascular Research Center
Dallas, Texas, 75226, United States
North Texas Endocrine Center
Dallas, Texas, 75231, United States
SW Family Medicine Associates
Dallas, Texas, 75235, United States
Baylor College Of Medicine
Houston, Texas, 77030, United States
Grace Research
Marshall, Texas, 75670, United States
Northwest Houston Clinical Research PLLC
Tomball, Texas, 77375, United States
Progressive Clinical Research
Bountiful, Utah, 84010, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
The University of Utah
Salt Lake City, Utah, 84132-0001, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Virginia Heart
Falls Church, Virginia, 22042, United States
Carient Heart and Vascular
Manassas, Virginia, 20109, United States
Dominion Medical Associates
Richmond, Virginia, 23219, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Swedish Medical Center-Cardiovascular Research
Seattle, Washington, 98122, United States
Univ of Washington Medical Center
Seattle, Washington, 98195, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506, United States
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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open label study
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2026
First Posted
April 8, 2026
Study Start
May 11, 2026
Primary Completion (Estimated)
January 9, 2030
Study Completion (Estimated)
January 9, 2030
Last Updated
June 10, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
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.