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

NCT06813911 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2026-05-13

No results posted yet for this study

Summary

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).

Conditions

  • Atherosclerotic Cardiovascular Disease (ASCVD)

Interventions

DRUG

Pelacarsen

Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection.

DRUG

Placebo

Placebo will be provided as solution for injection in prefilled syringe for subcutaneous injection.

DRUG

Inclisiran

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. After that inclisiran will be administered every 6 months, i.e., Month 5 and Month 11.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2028-02-03
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States
  • China
  • France
  • Germany
  • Hong Kong
  • Italy
  • Netherlands
  • Puerto Rico
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06813911 on ClinicalTrials.gov