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Pelacarsen Study for Elevated Lp(a) in ASCVD

This study is looking at a new treatment called pelacarsen for people with atherosclerotic cardiovascular disease (ASCVD), which is a condition where plaque builds up in your arteries. You might be able to join if you are between 18 and 80 years old, have ASCVD, and have high levels of a specific type of cholesterol called lipoprotein(a) or Lp(a). All participants will also receive inclisiran, another medication, as a background treatment. The main goal is to see how much pelacarsen can lower Lp(a) levels compared to a placebo (an inactive substance) over 6 months. The study is currently recruiting about 340 participants.

Study design
This is a randomized, double-blind study, meaning participants are randomly assigned to receive either pelacarsen or a placebo, and neither you nor your doctors will know which you are receiving. It will involve many different centers.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring Lp(a) levels is at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06813911

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

Recruiting
PHASE3Ages 18–80InterventionalTreatment
Novartis Pharmaceuticals
~340 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:PelacarsenPlaceboInclisiran

At a glance

Recruiting sites
75 of 95 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in log transformed lipoprotein A (Lp(a)) concentration
Measured over Baseline, 6 Months

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD)

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Where it's being run

95 sites across 45 states
Florida12
France9
Spain8
Germany6
Taiwan5
United Kingdom4
Michigan3
Texas3

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Change in log transformed lipoprotein A (Lp(a)) concentrationBaseline, 6 Months

    To evaluate the efficacy of Pelacarsen compared to placebo, in reducing Lp(a) levels at Month 6 in ASCVD participants who have elevated Lp(a), and who are on background inclisiran for elevated LDL-C