At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pelacarsen (TQJ230) 80mg (drug), Matching placebo (drug)
- How long the study runs
- Study runs about 72 months (dates as stated)
- About the drug or intervention
- Pelacarsen (TQJ230) 80mg — drug: Pelacarsen (TQJ230) 80mg · Matching placebo — drug: Matching placebo
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Novartis Pharmaceuticals, is looking at whether a medicine called pelacarsen (also known as TQJ230) can slow the worsening of calcific aortic valve stenosis — a narrowing of the heart's aortic valve caused by calcium build-up. It will test this in people who have mild or moderate aortic stenosis and high levels of a blood fat called lipoprotein(a), sometimes written as Lp(a).
Who can take part
- Men and women aged 50 to under 80
- A blood level of Lp(a) of 175 nmol/L or higher, measured at a central laboratory
- Mild or moderate calcific aortic valve stenosis
- Already receiving the best available treatment for existing heart and blood vessel risk factors at the randomisation visit
Who may not be able to
- Severe calcific aortic valve stenosis
- High blood pressure that is not under control
- Any history of cancer
- Past bleeding in the brain (haemorrhagic stroke) or other major bleeding
- Low platelet count
- Active liver disease or liver problems
- Significant kidney disease
- Women who are pregnant or breastfeeding
- Other criteria in the trial protocol may also apply
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about how many visits there are, how long the trial lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 50 Years to 80 Years
- Who
- All
- Number of participants
- 502
- Started
- 2024-03-07
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for aortic stenosis
- • Phase2 - 502 participants
- • The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis
Who can take part?
- • Ages 50 Years to 80 Years
- • Diagnosed with aortic stenosis
Where?
- • Reading - Novartis Investigative Site
- • Portadown - Novartis Investigative Site
- • Edinburgh - Novartis Investigative Site
- • Leicester - Novartis Investigative Site
- • +8 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 50 Years - 80 Years
- Who can join: All genders
What the study is looking for
- ✓Male and female ≥50 to \<80 years of age at Screening Part II
- ✓Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory
- ✓Mild or moderate calcific aortic valve stenosis
- ✓At the randomization visit, participant must be optimally treated for existing CV risk factors
Who cannot take part
- ✗Severe calcific aortic valve stenosis
- ✗Uncontrolled hypertension
- ✗History of cancer of any organ system
- ✗History of hemorrhagic stroke or other major bleeding
- ✗blood clotting cell count ≤ LLN
See the full criteria
Where Is This Study? (12 UK sites)
Novartis Investigative Site
Reading RG1 5AN, United Kingdom
Novartis Investigative Site
Portadown BT63 5QQ, United Kingdom
Novartis Investigative Site
Edinburgh EH16 4SA, United Kingdom
Novartis Investigative Site
Leicester LE3 9QP, United Kingdom
Novartis Investigative Site
Liverpool L14 3PE, United Kingdom
Novartis Investigative Site
London EC1A 7BE, United Kingdom
Novartis Investigative Site
London SE1 7EH, United Kingdom
Novartis Investigative Site
Londonderry BT47 6SB, United Kingdom
Novartis Investigative Site
Manchester M23 9LT, United Kingdom
Novartis Investigative Site
Middlesbrough TS4 3BW, United Kingdom
Novartis Investigative Site
Norwich NR4 7UY, United Kingdom
Novartis Investigative Site
Tyne and Wear NE29 8NH, United Kingdom
How to Get in Touch
Novartis Pharmaceuticals
Sponsor contactCONTACT
Novartis Pharmaceuticals
Sponsor contactCONTACT