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ACTIVE NOT RECRUITINGPhase3

Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD

Sponsor: Novartis Pharmaceuticals

NCT ID: NCT06813911

View on ClinicalTrials.gov ↗

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.

Atherosclerotic Cardiovascular Disease (ASCVD)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Key Inclusion criteria: * 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 arterial disease (PAD) at Screening visit * 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 randomized * On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to Randomization/Baseline visit * Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit * Central laboratory reported LDL-C \>70 mg/dL (or \>1.8 mmol/L) at Screening visit Key Exclusion Criteria: * 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 * History of malignancy of any organ system within the past 5 years * Myocardial infarction, stroke or other major bleeding, coronary or lower limb re vascularization, major cardiac or non-cardiac surgery between Screening visit and Randomization/Baseline visit (Day 1) * Central laboratory reported platelet count \<140,000 per mm3 * Active liver disease or hepatic dysfunction at Screening visit * Significant kidney disease at Screening visit * Pregnant or nursing women at Screening visit * Any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at Screening visit * Other protocol-defined inclusion/exclusion criteria may apply.

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

Data sourced from ClinicalTrials.gov · Last verified: 2026-08