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

Conditions

• Atherosclerotic Cardiovascular Disease (ASCVD)

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date

Apr 30, 2025

Status verified

May 2026

Primary completion

Feb 3, 2028

Completion

Feb 29, 2028

Study Design

Enrollment

340 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Pelacarsen
  Participants randomized in Pelacarsen arm, will be administered pelacarsen (TQJ230) subcutaneous injection once monthly for 12 months.
• Placebo Comparator: Placebo
  Participants will be administered placebo subcutaneous injection once monthly for 6 months. After Month 6, all participants will receive pelacarsen 80 mg injection for the remaining 6 months during the open-label treatment period.

Primary Outcome Measure

Change in log transformed lipoprotein A (Lp(a)) concentration [ Time Frame: Baseline, 6 Months ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111

Locations (37)

Find similar trials in Birmingham, AL

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