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Pelacarsen added to inclisiran for people with ASCVD and high Lp(a)

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Atherosclerotic Cardiovascular Disease (ASCVD), and Elevated LDL-C and Lp(a)

Phase 3 Interventional Novartis · NCT06813911

This trial will test whether adding pelacarsen to background inclisiran lowers lipoprotein(a) and is safe for adults with established ASCVD and high Lp(a).

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment340 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsevolocumab, alirocumab
Locations96 sites (Birmingham, Alabama and 95 other locations)
Trial IDNCT06813911 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 trial with a parallel-group design and a subsequent open-label treatment period. Eligible adults with documented ASCVD must complete a run-in period of inclisiran and have elevated Lp(a) and LDL-C to be randomized to pelacarsen versus placebo on top of standard lipid-lowering therapy. The study measures Lp(a) lowering, safety, tolerability, and prespecified cardiovascular outcomes over the treatment period. Participants are followed at multiple clinical research sites in the United States and receive regular laboratory and clinical assessments.

Who should consider this trial

Good fit: Adults aged 18–80 with documented ASCVD, central-lab Lp(a) ≥175 nmol/L, LDL-C >70 mg/dL, on stable guideline lipid therapy, and who complete the inclisiran run-in are ideal candidates.

Not a fit: People without elevated Lp(a), those who cannot use or complete the inclisiran run-in, or those with recent use of other PCSK9 inhibitors are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could substantially lower Lp(a) and potentially reduce the risk of heart attacks, strokes, and other cardiovascular events in people with ASCVD and very high Lp(a).

How similar studies have performed: Earlier-phase trials showed that pelacarsen produces substantial Lp(a) reductions, but cardiovascular outcome benefit has not yet been proven and remains the focus of this Phase 3 effort.

Eligibility criteria

Show full inclusion / exclusion 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 this trial is running

Birmingham, Alabama and 95 other locations

+46 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atherosclerotic Cardiovascular DiseaseLipoproteincardiovascular diseaseASCVDpelacarsen
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.