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Clinical Trial ● Currently Recruiting Phase III NCT06813911

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

Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD — Recruiting • Phase III • Cardiology / Cardiovascular • NCT06813911.

📅 16 Apr 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase III
NCT ID
NCT06813911
Sponsor
Novartis Pharmaceuticals
Start
2025-04-30
ClinicaliQ Trial Snapshot
  • Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD — Recruiting • Phase III • Cardiology / Cardiovascular • NCT06813911.
  • What is being tested: Pelacarsen (TQJ230), an antisense oligonucleotide therapy designed to lower lipoprotein(a) (Lp(a)), is being evaluated for efficacy and safety in patients already receiving inclisiran for LDL cholesterol reduction.
  • Patient eligibility overview: The trial targets individuals with established atherosclerotic cardiovascular disease (ASCVD) who have elevated Lp(a) levels and are currently on background inclisiran treatment for lipid management.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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).

Eligibility Snapshot
  • 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

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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