Pelacarsen

DRUG6 trials

Conditions

Acute Coronary Syndrome (ACS)Atherosclerotic Cardiovascular Disease (ASCVD)Atherosclerotic Cardiovascular Disease, ASCVDHealthy ParticipantsHepatic ImpairmentHyperlipoproteinemia (a)

Phase 1

Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Participants

CompletedNCT05026996

Novartis PharmaceuticalsHepatic Impairment

Start: 2021-11-23End: 2022-10-19Updated: 2024-10-09

A Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pelacarsen (ISIS 681257) in Healthy Japanese Participants

CompletedNCT05337878

Ionis Pharmaceuticals, Inc.Healthy Participants

Start: 2018-10-15End: 2019-12-18Updated: 2022-04-20

Phase 3

An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

Active, not recruitingNCT05900141

Novartis PharmaceuticalsHyperlipoproteinemia (a)

Start: 2023-09-29End: 2028-08-24Updated: 2025-08-06

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

RecruitingNCT06813911

Novartis PharmaceuticalsAtherosclerotic Cardiovascular Disease (ASCVD)

Start: 2025-04-30End: 2028-02-29Target: 340Updated: 2026-08-07

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

Not yet recruitingNCT07625306

Novartis PharmaceuticalsAcute Coronary Syndrome (ACS)

Start: 2026-08-31End: 2028-12-07Target: 240Updated: 2026-06-04

Unknown Phase

Managed Access Programs for TQJ230, Pelacarsen

NCT07000695

Novartis PharmaceuticalsAtherosclerotic Cardiovascular Disease, ASCVD

Updated: 2026-06-18

Related Papers

Pharmacokinetics and Safety of Pelacarsen, a GalNAc<sub>3</sub>-Conjugated Antisense Oligonucleotide Targeting Apo(a), in Participants With Mild Hepatic Impairment.

2025-10-01

Abstract 4135023: Effect of mild hepatic impairment on the pharmacokinetics of pelacarsen