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A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) with background inclisiran in participants with atherosclerotic cardiovascular disease, and elevated LDL-C and Lp(a)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516356-18-00
Acronym
CTQJ230A12304
Enrollment
188
Registered
2025-08-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-11

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

Change in log-transformed Lp(a) concentration from baseline at Month 6

Detailed description

Proportion of participants achieving Lp(a) levels <125 nmol/L at Month 6, Incidence of treatment emergent adverse events (TEAEs):, Incidence of treatment emergent serious adverse events (TESAEs), Incidence of treatment emergent adverse events of special interest (AESI), Incidence of study and treatment discontinuations due to TEAEs;, Observed value and change/shift from baseline in safety laboratory measures; • ECGs • Vital signs • Laboratory values (e.g. CBC, CMP, Liver Function Tests)

Interventions

DRUGINCLISIRAN
DRUGTQJ230
DRUGPlacebo to TQJ230 80 mg/0.8 mL Solution for injection in pre-filled syringe with needle safety device

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in log-transformed Lp(a) concentration from baseline at Month 6—

Secondary

MeasureTime frame
Proportion of participants achieving Lp(a) levels <125 nmol/L at Month 6, Incidence of treatment emergent adverse events (TEAEs):, Incidence of treatment emergent serious adverse events (TESAEs), Incidence of treatment emergent adverse events of special interest (AESI), Incidence of study and treatment discontinuations due to TEAEs;, Observed value and change/shift from baseline in safety laboratory measures; • ECGs • Vital signs • Laboratory values (e.g. CBC, CMP, Liver Function Tests)—

Countries

France, Germany, Italy, Netherlands, Spain

Outcome results

None listed

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