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CTRI Number  CTRI/2025/11/097263 [Registered on: 12/11/2025] Trial Registered Prospectively
Last Modified On: 15/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   An open-label extension (OLE) trial to evaluate long-term safety and tolerability of pelacarsen (TQJ230) 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
2024-519870-38-00  EudraCT 
CTQJ230A12301E1 Version 00 Dated 19 Dec 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Murugananthan K 
Designation  Country Monitoring Head 
Affiliation  Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai Mumbai MAHARASHTRA 400051 India
Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai Mumbai MAHARASHTRA 400051 India
Mumbai
MAHARASHTRA
400051
India 
Phone  912250243544  
Fax    
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Scientific Query
 
Name  Murugananthan K 
Designation  Country Monitoring Head 
Affiliation  Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai Mumbai MAHARASHTRA 400051 India
Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai Mumbai MAHARASHTRA 400051 India
Mumbai
MAHARASHTRA
400051
India 
Phone  912250243544  
Fax    
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Public Query
 
Name  Murugananthan K 
Designation  Country Monitoring Head 
Affiliation  Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai Mumbai MAHARASHTRA 400051 India
Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai Mumbai MAHARASHTRA 400051 India
Mumbai
MAHARASHTRA
400051
India 
Phone  912250243544  
Fax    
Email  murugananthan.k@novartis.com  
 
Source of Monetary or Material Support  
Novartis Pharma AG, Novartis Campus 4056 — Basel, Switzerland 
 
Primary Sponsor  
Name  Novartis Healthcare Pvt Ltd 
Address  6 and 7 floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai Mumbai MAHARASHTRA 400051 India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Chile
China
Colombia
Czech Republic
Dominican Republic
Egypt
Finland
France
Georgia
Germany
Greece
Guatemala
Hungary
Iceland
India
Indonesia
Israel
Italy
Japan
Jordan
Lebanon
Malaysia
Mexico
Netherlands
Norway
Peru
Philippines
Poland
Portugal
Republic of Korea
Romania
Russian Federation
Saudi Arabia
Singapore
Slovakia
South Africa
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 33  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashish Agrawal  Aakash Healthcare Pvt.Ltd  Aakash Healthcare Pvt.Ltd. Hospital Plot Road no-201 Sector -3 Dwarka-110075
New Delhi
DELHI 
9569060809

medashish@rediffmail.com 
Dr Navin Mathew  Amrita Institute of Medical Sciences and Research Centre   Dept of Cardiology 5th floor Tower1 Amrita Institute of Medical Sciences and Research Centre AIMS Ponekkara PO Kochi 682041 Kerala India
Thiruvananthapuram
KERALA 
9495480544

navinmathew@aims.amrita.edu 
Dr Abraham Oomman  Apollo Hospitals  Apollo Research and innvoation Flat no. 1/16 & 1/17 second floor, krishnadeep chambers, Chennai - 576102
Chennai
TAMIL NADU 
4428293333

abrahamoommandr@gmail.com 
Dr R Anil Kumar  ASTER MEDCITY ASTER DM HEALTHCARE  ASTER MEDCITY ASTER DM HEALTHCARE Kuttisahib Road near KOTHAD BRIDGE South Chittoor P O Cheranalloor Kochi 682027 Kerala India
Thiruvananthapuram
KERALA 
0484-6699864

dranil.kumar@asterhospital.com 
Dr Sunil Washimkar  Central India Cardiology Hospital and Research Institute,  Central India Cardiology Hospital Research Institute Nagpur Khamla Road Kapil Nagar Sawarkar Nagar Khamla Nagpur Maharashtra 440025
Nagpur
MAHARASHTRA 
9823065380

sunil_wash@rediffmail.com 
Dr Anil Jain  EPIC Hospital Unit of Vatsalya Healthcare  EPIC Hospital Unit of Vatsalya Healthcare LLP Rajpath Rangoli Road Opp. Pandit Dindayal Hall Bodakdev Ahmedabad-380054 Gujarat India
Ahmadabad
GUJARAT 
079 68155000

dranilrjain@yahoo.co.in 
Dr Vishal Rastogi  Fortis Escorts Heart Institute  Fortis Escorts Heart Institute, Okhla Road New Delhi-110025
New Delhi
DELHI 
9810176317

drvrastogi@yahoo.com 
Dr Rajpal Kanaklal Abhaichand   G KUPPUSWAMY NAIDU MEMORIAL HOSPITAL  G KUPPUSWAMY NAIDU MEMORIAL HOSPITAL P Box No 6327 Nethaji Road Paappanaickenpalayam Coimbatore 641037 Tamil Nadu
Coimbatore
TAMIL NADU 
9659266615

rka.trials@gmail.com 
Dr Ajay Kumar Pandey  Galaxy Life Care Services Pvt Ltd  Galaxy Hospital A Unit of Galaxy Lifecare Services Pvt Ltd., Plot No- 4 to 7, Dayal Enclave, Mahmoorganj, Varanasi, Uttar Pradesh- 221010
Varanasi
UTTAR PRADESH 
9415202323

dr.akpandeycardio@gmail.com 
Dr Tom Devasia  Kasturba Medical College and Hospital  Manipal Center for Clinical Research Near KMC Dean office Mezzanine Floor, KMC old library building, Kasturba Hospital, Manipal - 576 104 Contact no: (M) + 91 9880140180 (O) - 0820-2933532
Udupi
KARNATAKA 
9448158508

tomdevasia@hotmail.com 
Dr Rishi Sethi  King George’s Medical University  Dept Of Cardiology,King Georges Medical University, Luknow
Lucknow
UTTAR PRADESH 
9838571770

drrishisethi1@gmail.com 
DR PRASAD M R   KLES DR PRABHAKAR KORE HOSPITAL AND MEDICAL RESEARCH CENTER  KLES DR PRABHAKAR KORE HOSPITAL AND MEDICAL RESEARCH CENTER, G+2, OPD No 29, NEHRU NAGAR BELAGAUM KARNATAKA 590010
Belgaum
KARNATAKA 
9243245777

drprasadmr@gmail.com 
Dr Balamurugan Ramanathan  KOVAI DIABETES SPECIALITY CENTER AND HOSPITAL  KOVAI DIABETES SPECIALITY CENTER AND HOSPITAL, 15, Vivekananda Road, Ram Nagar, Coimbatore – 641009, Tamilnadu, India
Coimbatore
TAMIL NADU 
9842244881

rbmkdsc@gmail.com 
Dr Premchand Rajendra Kumar  Krishna Institute of Medical Sciences Ltd  1 8 31 1 Minister road Secunderabad Hyderabad Telangana
Hyderabad
TELANGANA 
9848029443

kumarpre@hotmail.com 
Dr P V Raghava Sarma  LALITHA SUPER SPECIALITIES HOSPITAL PVT. LTD  LALITHA SUPER SPECIALITIES HOSPITAL PVT. LTD KOTHAPET GUNTUR 522001 ANDHRAPRADESH
Guntur
ANDHRA PRADESH 
9866391141

drpvr.Issh@gmail.com 
Dr Jabir Abdullakutty  Lisie Hospital  Lisie Hospital Kochi Kerala 682018
Thiruvananthapuram
KERALA 
9447011773
0484-2402044
drjabi@yahoo.co.in 
Dr Chakrabhavi Basavegowda Keshavamurthy   Manipal Hospital   Manipal Hospital No. 85-86 Bangalore Mysore ring road junction Bannimantap A layout Mysore Karnataka 570015
Mysore
KARNATAKA 
9900152852

cbkeshavamurthy@gmail.com 
Dr Abhijit Joshi   Manipal Hospital PVT LTD  Manipal Hospital PVT LTD, Sr.No 111/11/1 Mahalunge Baner Road Opp D-Mart, Baner Pune, Maharashtra 411045 India
Pune
MAHARASHTRA 
9823074846

dr.abhijeetjoshi@yahoo.com 
Dr Urmil Shah  Marengo CIMS Hospital  Marengo CIMS Hospital, Ahmedabad, Plot No. 67/1, Opposite Panchamrut Bungalows, Near Shukan Mall, Off Science City Road Sola, Ahmedabad, Gujarat, India- 380060
Ahmadabad
GUJARAT 
9825066939

urmil.shah@cims.me 
Dr Gaurav Minocha  Max Superspeciality Hospital  W-3 Sec-1 NH 24 Vaishali Ghaziabad 201012 Ghaziabad UTTAR PRADESH
Ghaziabad
UTTAR PRADESH 
9910922299

gminocha27@yahoo.co.in 
Dr Nidheesh Mishra  New Era Hospital  New Era Hospital Near Jalrammandir Queta colony Telephone Exchange Square Central Avenue road Nagpur-440008
Nagpur
MAHARASHTRA 
9323078483

nidheeshmishra@gmail.com 
Dr Nirav Bhalani  Rhythm Heart Institute- A Unit of Synergy Lifecare Pvt. Ltd.  Rhythm Heart Institute- A Unit of Synergy Lifecare Pvt. Ltd. Cardiology Department, Lakulesh Park Society, near Sadhu Vaswani School,Vadodara- 390022
Vadodara
GUJARAT 
8128995863

trial@rhythmheart.com 
Dr Devendra Kumar Agarwal  S.P. Medical College and AG Hospitals  Dept. of Cardiology S.P. Medical College and AG Hospitals, Bikaner- 334003
Bikaner
RAJASTHAN 
9829217899

tippy1234@rediffmail.com 
Dr Sunil Sathe  Sahyadri Clinical Research And Development Centre  Sahyadri Clinical Research And Development Centre Hospital 33-34 B Makarand Bhave, Karve Road, Pune, Maharashtra 411004
Pune
MAHARASHTRA 
9975670710
2067215098
svscardcare@gmail.com 
Dr Shantanu Sengupta  Sengupta Hospital & Research Institute  Sengupta Hospital & Research Institute Ravinagar Square, Nagpur 440033
Nagpur
MAHARASHTRA 
9923190925

senguptasp@gmail.com 
Dr Tanuj Bhatia  Shri Guru Ram Rai Instutute of Medical and HEalth Sciences and Shri Mahant Indiresh Hospital  Shri Guru Ram Rai Instutute of Medical and Health Sciences and Shri Mahant Indiresh Hospital Patel Nagar Dehradun- 248001 Uttarakhand
Dehradun
UTTARANCHAL 
9936618283

ttanujbhatia21@rediffmail.com 
Dr Mahesh Fulwani  Shrikrishna Hrudayalaya and Critical Care Centre   Shrikrishna Hrudayalaya and Critical Care Centre Tikekar Road Congress Nagar Square Dhantoli Nagpur PIN 440012 Maharashtra
Nagpur
MAHARASHTRA 
9921120005
0712-2444434
maheshfulwani@yahoo.co.in 
Dr Manish Sharma  Sir Ganga Ram Hospital  Sir Ganga Ram Hospital 5th Floor Lift 12, research Department Sarhadi Gandhi Marg Rajinder Nagar New Delhi 110060
New Delhi
DELHI 
9716861422

doctormanishksharma@gmail.com 
Dr Vikrant Vijan  Vijan Hospital And Research Center (Vijan Cardiac and Critical Care)  Vijan Hospital and Research Center Vijan Cardiac and Critical Care Vijan House Dr Vijan Hosp Marg College Road Nashik 422 005 Maharashtra India
Nashik
MAHARASHTRA 
9767207475
0253-2315736
vikrantvijan@hotmail.com 
Dr Saratchandra Koduganti  Virinchi Hospital  Virinchi Hospital, Banjara Hills, Hyderabad, 500 034
Hyderabad
TELANGANA 
9848012212

saratkoduganti@gmail.com 
Dr Hemant Kokane  WMFs Villo Poonawal Memorial Hospital  WMFs Villo Poonawal Memorial Hospital S.No. 156 Pune Solapur road Hadapsar Pune - 411028.
Pune
MAHARASHTRA 
8446414692

hemantkokane@gmail.com 
Dr Rohith P Reddy   Yashoda Hospital  Yashoda Hospital,Raj Bhavan Road,Somajiguda,Hyderabad-500 082,Telangana State,India
Hyderabad
TELANGANA 
9849646335

p_rohith@yahoo.com 
Dr Prashanth R M  Yenepoya Medical College Hospital  Yenepoya Medical College, Ralakatte, University Road Deralakatte, Mangalore, Karnataka 575018
Dakshina Kannada
KARNATAKA 
9611777225

drprashanthrm@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 33  
Name of Committee  Approval Status 
EPIC Hospital Ethics Committee   Approved 
Sahyadri Hospitals Private Limited Ethics Committee  Approved 
Aakash Healthcare Institutional Ethics Committee  Approved 
Ethics Committee of Marengo Asia Healthcare Private Limited  Approved 
ETHICS COMMITTEE, S.P. Medical College  Approved 
Galaxy Hospital Ethics Committee,  Submittted/Under Review 
Institutional Ethics Committee Columbia Asia Hospital   Approved 
INSTITUTIONAL ETHICS COMMITTEE KLE University  Approved 
Institutional Ethics Committee Max Super Speciality Hospital  Approved 
Institutional Ethics Committee of Kovai Diabetes Speciality Centre & Hospital  Approved 
Institutional Ethics Committee WMFs Villoo Poonawalla Memorial Hospital   Approved 
Institutional Ethics Committee, Academics and Research Department-Fortis Escorts Heart Institute   Submittted/Under Review 
Institutional ethics committee, Amrita Institute of Medical Sciences   Approved 
INSTITUTIONAL ETHICS COMMITTEE, ASTER MEDCITY   Approved 
Institutional Ethics Committee, King Georges Medical University  Approved 
Institutional Ethics Committee, Lisie Hospital   Approved 
Institutional Ethics Committee, Manipal Hospital PVT LTD  Approved 
Institutional Ethics Committee,Yashoda Academy of Medical Education& Research  Approved 
Institutional Ethics Committee- Clinical Studies, Apollo Hospitals  Approved 
Institutional Ethics Committee-GKNM Hospital  Approved 
Institutional Ethics Committee-SGRR Institute Of Medical Health Sciences  Approved 
KIMS Ethics Committee  Approved 
LALITHA SUPERSPECIALITIES HOSPITAL ETHICS COMMITTEE  Approved 
MAHE, Ethics committee  Approved 
NewEra Hospital Ethics Committee  Approved 
Rhythm Heart Institute Ethics Committee  Approved 
Sengupta Hospital & Research Institute Ethics Committee  Approved 
Sir Ganga Ram Hospital Ethics Committee  Submittted/Under Review 
Vijain Hospital Ethics Committee  Approved 
Virinchi Hospitals   Approved 
Virtuous Institutional Medical Research Committee  Approved 
Virtuous Institutional Medical Research EC Shrikrishna Hrudayalaya and Critical Care Centre  Approved 
Yenepoya Ethics committee-1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I519||Heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pelacarsen (TQJ230)   80 mg QM s.c. approximately 3 years 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Participants who have provided informed consent prior to initiation of any study-specific
activities/procedures.
Participants who have completed the parent study while still on assigned investigational
product. 
 
ExclusionCriteria 
Details  Participants who for any reason permanently discontinued or 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 participants at risk or interfere with the study participation,
including, but not restricted to conditions outlined in protocol.
Participants are receiving another investigational drug or device before the open-label
treatment period
Pregnant or nursing (breastfeeding) women
Women of childbearing potential unless they are using highly effective methods of
contraception 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the long-term safety and tolerability of
pelacarsen (TQJ230) in participants with elevated
Lp(a) and established CVD who have completed the
parent Lp(a)HORIZON study 
End of study 
 
Secondary Outcome  
Outcome  TimePoints 
Time to the first occurrence of
4P-MACE
 
from parent study
baseline & from OLE Study baseline

 
Cumulative number of 4P-MACE over time   from parent study baseline & OLE study baseline 
Observed value & change
in Lp(a) 
from parent study baseline & OLE study baseline 
 
Target Sample Size   Total Sample Size="5700"
Sample Size from India="460" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial
Modification(s)  
Phase 3 
Date of First Enrollment (India)   05/05/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  26/05/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="7"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

A single arm, multicenter, open-label extension (OLE) trial to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established CVD who have completed the parent Lp(a)HORIZON study and to evaluate the long-term efficacy of pelacarsen (TQJ230) on 4P-MACE (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death and urgent coronary revascularization requiring hospitalization) To evaluate the long-term efficacy of pelacarsen (TQJ230) in lowering Lp(a). TQJ230) is commercially available assuming that superiority of pelacarsen (TQJ230) over placebo regarding MACE reduction was demonstrated in the parent study.

· Trial Design:

1. Screening period (up to approximately 30 days): Participants can be screened at or within 3 months of the End of study (EOS) visit of the parent study, or within 3 months of country/local approval of the OLE study if the approval occurs after the EOS visit of the parent study. If screening visit coincides with or occurs within 60 days of the EOS visit of the parent study, the safety assessments completed as part of EOS visit can be used for screening eligibility assessment. If the screening visit occurs later than 60 days from the EOS visit, new safety assessments and medical review will be required to confirm eligibility. Open-label treatment period (minimum 24 months).

2. Treatment of Interest: Pelacarsen (TQJ230) 80 mg QM s.c.

3. Treatment Groups: Participants who completed the parent study will be given open label pelacarsen (TQJ230) 80 mg.

4. Number of Participants: Approximately 5,700 participants from the parent study are expected to participate.

5. Key Inclusion Criteria: Participants who have provided informed consent prior to initiation of any study-specific activities/procedures. Participants who have completed the parent study while still on assigned investigational product.

6. Key Exclusion Criteria: Participants who for any reason permanently discontinued or 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 participants at risk or interfere with the study participation, including, .Participants are receiving another investigational drug or device before the open-label treatment period Pregnant or nursing (breastfeeding) women of childbearing potential unless they are using highly effective methods of contraception

7. Treatment duration: Once enrolled in the study, participants will commence with open label pelacarsen (TQJ230) and may continue on the study until (whichever is sooner): 3 years after LPFV of the participant in the country, or the benefit-risk profile of pelacarsen (TQJ230) is no longer positive, or pelacarsen (TQJ230) becomes commercially available and subsequently reimbursed in the country or, when reimbursement is not possible, the product is launched in the country, or, if a marketing application of an investigator product is rejected in a region/country for the indication under study.

End of study is defined as when the last participant finishes his/her EOS visit, and any repeat assessments associated with this visit have been documented and followed up appropriately by the Investigator. All participants were instructed in regular intervals in the parent study to comply with lifestyle changes according to local and international recommendations, and this is also encouraged in the OLE study. A screen failure occurs when a participant who consents to participate in the OLE study is subsequently found

to be ineligible and therefore not entered in the study. Participants who screen failed due to safety lab assessments can be rescreened. However, the rescreening must be done within 3 months from the country/local approval of the OLE study or EOS visit of the parent study, whichever occurs later. Participants will not be replaced in this study. No additional treatment beyond the open-label pelacarsen (TQJ230) is included in this study

 
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