A single arm, multicenter, open-label extension (OLE) trial to evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants who completed the parent Lp(a)HORIZON trial

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519870-38-00

Acronym

CTQJ230A12301E1

Enrollment

2773

Registered

2025-08-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic cardiovascular disease (ASCVD)

Brief summary

● Occurrence of the followings: • Treatment Emergent Adverse Events (TEAEs) • Treatment Emergent Serious Adverse Events (TESAEs) • Treatment discontinuations due to TEAEs/TESAEs, ● TEAEs of special interest Observed value or change/shift from baseline in: • Safety laboratory measures • Vital signs

Detailed description

Time to the first occurrence of 4P-MACE from parent study baseline, Time to the first occurrence of 4P-MACE from OLE study baseline, Cumulative number of 4P-MACE over time from parent study baseline, Cumulative number of 4P-MACE over time from OLE study baseline, Observed value and change in Lp(a) from the parent study baseline, Observed value and change in Lp(a) from the OLE study baseline

Interventions

DRUGTQJ230

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
● Occurrence of the followings: • Treatment Emergent Adverse Events (TEAEs) • Treatment Emergent Serious Adverse Events (TESAEs) • Treatment discontinuations due to TEAEs/TESAEs, ● TEAEs of special interest Observed value or change/shift from baseline in: • Safety laboratory measures • Vital signs	—

Secondary

Measure	Time frame
Time to the first occurrence of 4P-MACE from parent study baseline, Time to the first occurrence of 4P-MACE from OLE study baseline, Cumulative number of 4P-MACE over time from parent study baseline, Cumulative number of 4P-MACE over time from OLE study baseline, Observed value and change in Lp(a) from the parent study baseline, Observed value and change in Lp(a) from the OLE study baseline	—

Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Iceland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026