phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD

A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With Established Cardiovascular Disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225280

Enrollment

7680

Registered

2020-07-17

Start date

2020-07-28

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

patients with established CVD and elevated Lp(a)

Interventions

Drug: TQJ230 TQJ230 80 mg injected monthly administered subcutaneously Drug: Placebo Placebo to match TQJ230 prefilled syringe to be injected subcutaneously

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Lp(a) =>70 mg/dL at the screening visit, measured at the Central laboratory Myocardial infarction: >= 3 months from screening and randomization to =3 months from screening and randomization to =< 10 years prior to the screening visit Clinically significant symptomatic peripheral artery disease

Exclusion criteria

Exclusion criteria: Uncontrolled hypertension Heart failure New York Heart Association (NYHA) class IV History of malignancy of any organ system History of hemorrhagic stroke or other major bleeding Platelet count=<LLN Active liver disease or hepatic dysfunction Significant kidney disease Pregnant or nursing women

Design outcomes

Primary

Measure	Time frame
efficacy Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated Lp(a) =>70 mg/dL and/or => 90 mg/dL	—

Countries

Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America

Contacts

Public ContactHideki Maruyama

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026