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 (drug), Placebo (drug), Inclisiran (drug)
- How long the study runs
- Study runs about 34 months (dates as stated)
- About the drug or intervention
- Pelacarsen — drug: Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection. · Placebo — drug: Placebo will be provided as solution for injection in prefilled syringe for subcutaneous injection. · Inclisiran — drug: All participants will be administered two loading doses of inclisiran as background treatment at Run-in 1 and Run-in 2, separated by 3 months, according to the approved label.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Novartis Pharmaceuticals, is testing whether pelacarsen (also called TQJ230) can lower a blood fat called Lp(a) in people with high Lp(a) levels and established disease of the heart, brain or leg arteries (known as atherosclerotic cardiovascular disease, or ASCVD). Everyone in the study also takes a background cholesterol medicine called inclisiran.
Who can take part
- Adults aged 18 to 80 at screening
- Have established atherosclerotic cardiovascular disease (ASCVD), meaning documented coronary heart disease, cerebrovascular disease, or peripheral arterial disease
- Already taking a stable dose of guideline-recommended cholesterol-lowering treatment for at least 30 days before screening
- Must successfully complete a run-in period of background inclisiran treatment before being randomly placed in a study group
- On standard treatment for other heart risk factors, such as high blood pressure and diabetes, for at least 30 days before the baseline visit
- Lp(a) level of 175 nmol/L or higher on the central laboratory test at screening
- LDL cholesterol above 70 mg/dL (or above 1.8 mmol/L) on the central laboratory test at screening
Who may not be able to
- Previous treatment with inclisiran
- Use of any other PCSK9 inhibitor (for example evolocumab or alirocumab) within 4 months before screening
- Uncontrolled high blood pressure at the baseline visit
- Severe heart failure (New York Heart Association class IV) at screening or baseline
- Triglycerides of 400 mg/dL or higher at screening
- Any cancer in the past 5 years
- Heart attack, stroke, major bleeding, certain procedures to restore blood flow, or major surgery between screening and baseline
- Platelet count below 140,000 per mm3 on the central laboratory test
- Active liver disease or liver problems at screening
- Significant kidney disease at screening
- Women who are pregnant or breastfeeding
- Any uncontrolled long-term or serious health condition that could pose an immediate risk to the person's stability
What taking part involves
- • Taking pelacarsen (TQJ230) or being in a comparison group (details not stated — ask the trial team)
- • Taking a background medicine called inclisiran, including a run-in period before the main study starts
Time commitment: Number of visits and study duration: not stated — ask the trial team.
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
- 18 Years to 80 Years
- Who
- All
- Number of participants
- 246
- Started
- 2025-04-30
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for atherosclerotic cardiovascular disease (ascvd)
- • Phase3 - 246 participants
- • The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C)
Who can take part?
- • Ages 18 Years to 80 Years
- • Diagnosed with atherosclerotic cardiovascular disease (ascvd)
Where?
- • Chichester - Novartis Investigative Site
- • London - Novartis Investigative Site
- • London - Novartis Investigative Site
- • Manchester - Novartis Investigative Site
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C).
More detail
This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study followed by an open-label treatment period.
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: 18 Years - 80 Years
- Who can join: All genders
What the study is looking for
- ✓Male and female participants 18 to ≤80 years of age at Screening visit
- ✓Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral...
- ✓On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit
- ✓Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomly assigned
- ✓On the usual treatment (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30...
Who cannot take part
- ✗Prior treatment with inclisiran
- ✗Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit
- ✗Uncontrolled hypertension at Randomization/Baseline visit
- ✗Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1)
- ✗Triglycerides ≥400 mg/dL at Screening visit
See the full criteria
Where Is This Study? (5 UK sites)
Novartis Investigative Site
Chichester PO19 6SE, United Kingdom
Novartis Investigative Site
London EC1M 6BQ, United Kingdom
Novartis Investigative Site
London W12 0HS, United Kingdom
Novartis Investigative Site
Manchester M13 9WL, United Kingdom
Novartis Investigative Site
Tyne and Wear NE29 8NH, United Kingdom
