Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With CVD (Lp(a)HORIZON)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04023552 |
Recruitment Status :
Recruiting
First Posted : July 17, 2019
Last Update Posted : January 15, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiovascular Disease and Lipoprotein(a) | Drug: TQJ230 Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 7680 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With Established Cardiovascular Disease |
Actual Study Start Date : | December 12, 2019 |
Estimated Primary Completion Date : | June 7, 2024 |
Estimated Study Completion Date : | June 10, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: TQJ230
TQJ230 80 mg injected monthly administered subcutaneously
|
Drug: TQJ230
TQJ230 80 mg injected monthly administered subcutaneously |
Placebo Comparator: Placebo
Monthly subcutaneous injections.
|
Drug: Placebo
Placebo to match TQJ230 prefilled syringe to be injected subcutaneously
Other Name: Placebo to match TQJ230 |
- Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated Lp(a) ≥ 70 mg/dL [ Time Frame: approximately 4 years ]Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in the overall study population with established CVD and (Lp(a) ≥ 70 mg/dL)
- Time to the first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in a population of patients with elevated Lp(a) ≥ 90 mg/dL. [ Time Frame: approximately 4 years ]Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in the overall study population with established CVD and (Lp(a) ≥ 90 mg/dL)
- Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of major adverse cardiovascular events (CV death, non-fatal MI, and non-fatal stroke) [ Time Frame: approximately 4 years ]Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the MACE composite of CV death, nonfatal MI and non-fatal stroke.
- Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of coronary heart disease: coronary heart disease death, non-fatal MI, urgent coronary re-vascularization requiring hospitalization [ Time Frame: approximately 4 years ]Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the composite of coronary heart disease (CHD) outcomes: death due to CHD, nonfatal MI and urgent coronary revascularization requiring hospitalization.
- Number of participants with confirmed all-cause death [ Time Frame: approximately 4 years ]Evaluation by clinical endpoint committee the rate of all-cause death

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria
- Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory
- Myocardial infarction: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
- Ischemic stroke: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
- Clinically significant symptomatic peripheral artery disease
Key Exclusion Criteria
- Uncontrolled hypertension
- Heart failure New York Heart Association (NYHA) class IV
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Platelet count ≤LLN
- Active liver disease or hepatic dysfunction
- Significant kidney disease
- Pregnant or nursing women
Other protocol-defined inclusion/exclusion criteria may apply at the end.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023552
Contact: Novartis Pharmaceuticals | 1-888-669-6682 | novartis.email@novartis.com | |
Contact: Novartis Pharmaceuticals | +41613241111 |


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Szekesfehervar, Fejer, Hungary, 8000 | |
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Budapest, HUN, Hungary, 1204 | |
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Mateszalka, Hungary, 4700 | |
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Vadodara, Gujarat, India, 390022 | |
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Bengaluru, Karnataka, India, 560024 | |
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Kochi, Kerala, India, 682 018 | |
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Kozhikode, Kerala, India, 673008 | |
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Mumbai, Maharashtra, India, 401107 | |
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Nagpur, Maharashtra, India, 440008 | |
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Nagpur, Maharashtra, India, 440009 | |
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Nagpur, Maharashtra, India, 440012 | |
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Nashik, Maharashtra, India, 422 005 | |
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Secunderabad, Telangana, India, 500003 | |
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Lucknow, Uttar Pradesh, India, 226003 | |
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Varanasi, Uttar Pradesh, India, 221010 | |
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Varanasi, Uttar Pradesh, India, 224105 | |
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DehraDun, Uttarakhand, India, 248001 | |
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Belagavi, India, 590010 | |
Israel | |
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Beer-Sheva, Israel, 8457108 | |
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Haifa, Israel, 3436212 | |
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Jerusalem, Israel, 91120 | |
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Petach Tikva, Israel, 49100 | |
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Ramat Gan, Israel, 52621 | |
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Tel Giborim, Holon, Israel, 58100 | |
Italy | |
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Milano, MI, Italy, 20162 | |
Japan | |
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Asahi, Chiba, Japan, 289-2511 | |
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Funabashi, Chiba, Japan, 273-8588 | |
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Matsudo-city, Chiba, Japan, 270-2251 | |
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Kitakyushu-city, Fukuoka, Japan, 802-8555 | |
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Kure-city, Hiroshima, Japan, 737-0023 | |
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Komatsu, Ishikawa, Japan, 923-0961 | |
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Takamatsu city, Kagawa, Japan, 760 8557 | |
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Sendai city, Miyagi, Japan, 980 0873 | |
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Miyhazaki-city, Miyazaki, Japan, 880-2102 | |
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Osaka-city, Osaka, Japan, 543-0035 | |
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Kawaguchi-city, Saitama, Japan, 333-0842 | |
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Sayama-city, Saitama, Japan, 350-1305 | |
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Chuo ku, Tokyo, Japan, 104-8560 | |
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Chuo-ku, Tokyo, Japan, 103-0027 | |
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Hachioji-city, Tokyo, Japan, 192-0918 | |
Korea, Republic of | |
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Daegu, Dalseo Gu, Korea, Republic of, 42602 | |
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Wonju, Gangwon-Do, Korea, Republic of, 26426 | |
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Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620 | |
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Suwon si, Gyeonggi Do, Korea, Republic of, 16499 | |
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Seoul, Korea, Korea, Republic of, 08308 | |
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Seoul, KOR, Korea, Republic of, 03181 | |
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Busan, Korea, Republic of, 49201 | |
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Gwangju, Korea, Republic of, 61469 | |
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Incheon, Korea, Republic of, 405 760 | |
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Seoul, Korea, Republic of, 02841 | |
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Seoul, Korea, Republic of, 03080 | |
Netherlands | |
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Apeldoorn, DZ, Netherlands, 7334 | |
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Sneek, The Netherlands, Netherlands, 8601 ZR | |
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Alkmaar, Netherlands, 1815 JD | |
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Amersfoort, Netherlands, 3813 TZ | |
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Amsterdam, Netherlands, 1090 HM | |
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Amsterdam, Netherlands, 1105 AZ | |
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Arnhem, Netherlands, 6815 AD | |
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Delft, Netherlands, 2625 AD | |
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Den Haag, Netherlands, 2545 CH | |
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Deventer, Netherlands, 7416 SE | |
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Enschede, Netherlands, 7512KZ | |
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Gouda, Netherlands, 2803 HH | |
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Groningen, Netherlands, 9728 NZ | |
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Hardenberg, Netherlands, 7770 AA | |
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Heemstede, Netherlands, 2102 CW | |
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Heerlen, Netherlands, 6419 | |
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Leiderdorp, Netherlands, 2353 GA | |
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Nijmegen, Netherlands, 6500 HB | |
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Nijmegen, Netherlands, 6532 SZ | |
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Tilburg, Netherlands, 5042 AD | |
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Utrecht, Netherlands, 3584 CX | |
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Venlo, Netherlands, 5912 BL | |
Norway | |
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Oslo, Norway, 0514 | |
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Skedsmokorset, Norway, 2020 | |
Poland | |
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Tarnow, Malopolskie, Poland, 33-100 | |
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Warszawa, Mazowieckie, Poland, 00-892 | |
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Kedzierzyn Kozle, Poland, 47 220 | |
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Krakow, Poland, 30-082 | |
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Krakow, Poland, 31 216 | |
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Lodz, Poland, 91-347 | |
Portugal | |
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Coimbra, Portugal, 3000 075 | |
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Guimaraes, Portugal, 4835-044 | |
Russian Federation | |
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Chelyabinsk, Russian Federation, 454047 | |
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Ekaterinburg, Russian Federation, 620137 | |
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Ivanovo, Russian Federation, 153012 | |
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Izhevsk, Russian Federation, 426061 | |
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Kirov, Russian Federation, 610035 | |
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Krasnodar, Russian Federation, 350086 | |
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Moscow, Russian Federation, 101990 | |
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Moscow, Russian Federation, 115516 | |
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Moscow, Russian Federation, 117198 | |
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Moscow, Russian Federation, 121552 | |
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Moscow, Russian Federation, 127473 | |
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Novosibirsk, Russian Federation, 630090 | |
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Petrozavodsk, Russian Federation, 185019 | |
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Rostov on Don, Russian Federation, 344022 | |
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Ryazan, Russian Federation, 390039 | |
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Saint Petersburg, Russian Federation, 194354 | |
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Saint Petersburg, Russian Federation, 195067 | |
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Saint Petersburg, Russian Federation, 195197 | |
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Saint Petersburg, Russian Federation, 197341 | |
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Saint Petersburg, Russian Federation, 198328 | |
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Saint-Petersburg, Russian Federation, 191186 | |
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Saint-Petersburg, Russian Federation, 196143 | |
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Saratov, Russian Federation, 410012 | |
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Saratov, Russian Federation, 410028 | |
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Sochy, Russian Federation, 354002 | |
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St Petersburg, Russian Federation, 195197 | |
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St Petersburg, Russian Federation, 197136 | |
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St-Petersburg, Russian Federation, 196084 | |
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Tomsk, Russian Federation, 634009 | |
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Ulyanovsk, Russian Federation, 432063 | |
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Vsevolozhsk, Russian Federation, 188640 | |
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Yaroslavl, Russian Federation, 150047 | |
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Yekaterinburg, Russian Federation, 620109 | |
Slovakia | |
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Banska Bystrica, Slovak Republic, Slovakia, 974 01 | |
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Komarno, Slovak Republic, Slovakia, 94501 | |
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Rimavska Sobota, Slovak Republic, Slovakia, 97901 | |
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Handlova, SVK, Slovakia, 97251 | |
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Zilina, Zilinsky Kraj, Slovakia, 010 01 | |
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Bardejov, Slovakia, 085 01 | |
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Bardejov, Slovakia, 08501 | |
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Bratislava, Slovakia, 821 07 | |
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Bratislava, Slovakia, 833 05 | |
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Bratislava, Slovakia, 833 48 | |
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Bratislava, Slovakia, 85101 | |
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Bratislava, Slovakia, 85107 | |
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Brezno, Slovakia, 97701 | |
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Dolny Kubin, Slovakia | |
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Komarno, Slovakia, 94501 | |
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Kosice, Slovakia, 040 01 | |
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Lucenec, Slovakia, 98439 | |
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Nitra, Slovakia, 949 01 | |
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Nitra, Slovakia, 94901 | |
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Nove Zamky, Slovakia, 940 01 | |
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Nove Zamky, Slovakia, 94002 | |
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Piestany, Slovakia, 921 01 | |
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Povazska Bystrica, Slovakia, 01701 | |
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Presov, Slovakia, 080 01 | |
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Presov, Slovakia, 08001 | |
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Rimavska Sobota, Slovakia, 97901 | |
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Trnava, Slovakia, 917 75 | |
Spain | |
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Cordoba, Andalucia, Spain, 14004 | |
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Sevilla, Andalucia, Spain, 41009 | |
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Sevilla, Andalucia, Spain, 41013 | |
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Sevilla, Andalucia, Spain, 41014 | |
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Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
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Santander, Cantabria, Spain, 39008 | |
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Badalona, Catalunya, Spain, 08916 | |
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Barcelona, Catalunya, Spain, 08036 | |
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Caceres, Extremadura, Spain, 10003 | |
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Santiago de Compostela, Galicia, Spain, 15706 | |
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A Coruna, Spain, 15001 | |
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Barcelona, Spain, 08025 | |
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Huelva, Spain, 21080 | |
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Madrid, Spain, 28041 | |
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Zaragoza, Spain, 50009 | |
Sweden | |
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Goethenburg, Sweden | |
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Lund, Sweden, 222 21 | |
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Stockholm, Sweden, 14186 | |
Switzerland | |
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Basel, Switzerland, 4031 | |
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Geneve 14, Switzerland, 1211 | |
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Lausanne, Switzerland, 1011 | |
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Liestal, Switzerland, 4410 | |
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Zuerich, Switzerland, 8091 | |
Taiwan | |
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Taichung, Taiwan ROC, Taiwan, 40201 | |
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Kaohsiung, Taiwan, 80756 | |
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Tainan, Taiwan, 71004 | |
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Taipei, Taiwan, 11217 | |
United Kingdom | |
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London, GBR, United Kingdom, EC1M 6BQ | |
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Chichester, West Sussex, United Kingdom, PO19 6SE | |
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Glasgow, United Kingdom, G20 0XA | |
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Newcastle upon Tyne, United Kingdom, NE7 7DN | |
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Norwich, United Kingdom, NR4 7UY | |
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Tyne And Wear, United Kingdom, NE29 8NH | |
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Wiltshire, United Kingdom, SN15 2SB |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT04023552 |
Other Study ID Numbers: |
CTQJ230A12301 CTQJ230A12301 ( Other Identifier: Novartis ) 2019-001076-11 ( EudraCT Number ) |
First Posted: | July 17, 2019 Key Record Dates |
Last Update Posted: | January 15, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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 the applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Lipoprotein(a), Lp(a),CVD, myocardial infarction, PAD,Stroke |
Cardiovascular Diseases |