Last Update: Apr 08, 2026
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 Identifier:
NCT07517263
Novartis Reference Number:CTQJ230A12301E1
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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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). 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).

Cardiovascular Disease and Lipoprotein(a)
Phase3
Recruiting
5700
Apr 13, 2026
Jan 09, 2030
All
18 Years - 100 Years (Adult, Older Adult)

Interventions

Drug

Pelacarsen (TQJ230)

pelacarsen 80mg s.c. monthly

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.

Novartis Investigative Site

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Mar del Plata,Buenos Aires,7600,Argentina

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Huy,4500,Belgium

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São Paulo,São Paulo,01323 000,Brazil

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Santo André,São Paulo,09090-790,Brazil

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San Gil,684031,Colombia

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Trutnov,460 63,Czechia

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Prague,128 08,Czechia

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Pardubice,532 03,Czechia

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Ostrava,700 30,Czechia

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Most,434 01,Czechia

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Kolín,280 20,Czechia

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Český Krumlov,381 01,Czechia

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Broumov,550 01,Czechia

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Brno,625 00,Czechia

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Brno,602 00,Czechia

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Kroměříž,Czech Republic,767 55,Czechia

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Uherské Hradiště,686 01,Czechia

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Valašské Meziříčí,75742,Czechia

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Frankfurt am Main,Hesse,60590,Germany

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Hanover,Lower Saxony,30159,Germany

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Jena,Thuringia,07740,Germany

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Dortmund,44137,Germany

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Essen,45277,Germany

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Lüneburg,21339,Germany

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Magdeburg,39120,Germany

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Meissen,01662,Germany

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München,80636,Germany

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Dehradun,Uttarakhand,248001,India

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Haifa,3436212,Israel

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Bergamo,BG,24127,Italy

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Brescia,BS,25123,Italy

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Milan,MI,20138,Italy

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Milan,MI,20149,Italy

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Milan,MI,20162,Italy

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Rozzano,MI,20089,Italy

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Tiel,Gelderland,4002 wp,Netherlands

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Sneek,Provincie Friesland,8601 zk,Netherlands

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Baia Mare,Maramureş,430123,Romania

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Buzău,120133,Romania

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Bardejov,085 01,Slovakia

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Handlová,972 51,Slovakia

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Lučenec,984 01,Slovakia

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Piešťany,921 01,Slovakia

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Prešov,080 01,Slovakia

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Rimavská Sobota,979 01,Slovakia

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Svidník,089 01,Slovakia

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Badalona,Barcelona,08916,Spain

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L'Hospitalet de Llobregat,Barcelona,08907,Spain

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Cáceres,Extremadura,10003,Spain

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A Coruña,15001,Spain

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Córdoba,14004,Spain

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Huelva,21080,Spain

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Málaga,29010,Spain

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Seville,41009,Spain

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Lausanne,1010,Switzerland

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Liestal,4410,Switzerland

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Izmir,Balcova,35340,Turkey (Türkiye)

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Istanbul,Fatih,34098,Turkey (Türkiye)

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Istanbul,Kadikoy,34668,Turkey (Türkiye)

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Eskişehir,Odunpazari,26040,Turkey (Türkiye)

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Mersin,Yenisehir,33110,Turkey (Türkiye)

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Izmir,35100,Turkey (Türkiye)

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Newport,Np20 2ub,United Kingdom

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Sheffield,S5 7au,United Kingdom

Inova Fairfax Hospital

Recruiting

Falls Church,Virginia,22042,United States

Joanne Wotring
Jared Spitz

Cardiology Consultants of Philadelphia

Recruiting

Yardley,Pennsylvania,19067,United States

Sharon Budzinski
+1 215 321 7400#242
Paul Grena

Wake Forest University Baptist Medical Center

Recruiting

Winston-Salem,North Carolina,27157,United States

Herman Barrett Cheek
Ginger Leonard
+1 336 885 6168

Wayne State University

Recruiting

Detroit,Michigan,48201,United States

Thomas Mazzocco
313-745-3246
Brian J O Neil

Interv Cardiology Med Grp

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West Hills,California,91307,United States

Michael Fam
818-235-7104
Farhad Rafii

Manshadi Heart Institute

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Stockton,California,95204,United States

Ramin Manshadi
Delaina Sanguinetti

Helping Hands Medical Associates INC

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Santa Ana,California,92704,United States

Maggie Romero
714-662-2900
Alan Charles Schwartz

UCSF

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San Francisco,California,94115,United States

Liliann Zou
415-514-0992
Eveline O Stock

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

+41613241111

Novartis Pharmaceuticals

1-888-669-6682