Lp(a) Lowering Study of Pelacarsen (TQJ230) in Patients in the US With Elevated Lp(a) and Recent ACS (STEMI/NSTEMI) - Lp(a)FRONTIERS PEARL

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07625306
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Acute Coronary Syndrome (ACS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Pelacarsen — DRUG
    Pelacarsen 80 mg subcutaneously (s.c.) once a month (QM)
  • Placebo — DRUG
    Placebo subcutaneously (s.c.) once a month (QM)

Study Details

CTQJ230A1US13 is a randomized, double-blind, placebo-controlled, multicenter phase IIIb study designed to evaluate the efficacy, safety, tolerability, and coronary plaque effects of early pelacarsen (TQJ230) initiation in participants with elevated Lp(a) and recent acute coronary syndrome (ACS).

Key Dates

Start date
Aug 31, 2026
Status verified
May 2026
Primary completion
Dec 7, 2028
Completion
Dec 7, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pelacarsen
    Pelacarsen (TQJ230) 80 mg s.c. QM
  • Placebo Comparator: Placebo
    Corresponding placebo s.c. QM

Primary Outcome Measure

Change in log-transformed Lp(a) concentration [ Time Frame: Baseline, Day 180 ]

Central Contacts

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