Pelacarsen for Cardiovascular Disease
(Lp(a)HORIZON Trial)

Recruiting in Palo Alto (17 mi)

+536 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment to lower heart-related risks in patients who already have heart disease and high levels of a specific blood substance called Lp(a). Research is ongoing to find effective treatments for this condition.

Eligibility Criteria

This trial is for people with cardiovascular disease who've had a heart attack or ischemic stroke between 3 months and 10 years ago, or have significant peripheral artery disease. They must also have high levels of Lp(a), a type of cholesterol particle, as confirmed by the central lab. It's not open to those with active liver disease, severe kidney issues, uncontrolled blood pressure, advanced heart failure, low platelets count, cancer history or recent major bleeding.

Inclusion Criteria

I have severe leg pain due to poor blood circulation.

I had a heart attack between 3 months and 10 years ago.

Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory

See 3 more

Exclusion Criteria

I have a serious kidney condition.

Platelet count ≤LLN

My heart condition severely limits my physical activity.

See 5 more

Treatment Details

Interventions

Pelacarsen (TQJ230) (Antisense Oligonucleotide)

Trial OverviewThe study tests Pelacarsen (TQJ230) to see if it can reduce the risk of serious heart events in patients with existing cardiovascular conditions and elevated Lp(a). Participants will either receive TQJ230 or a placebo without knowing which one they're getting to compare outcomes fairly.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TQJ230Experimental Treatment1 Intervention

TQJ230 80 mg injected monthly administered subcutaneously

Group II: PlaceboPlacebo Group1 Intervention

Monthly subcutaneous injections.