Pelacarsen for Cardiovascular Disease

(Lp(a)HORIZON Trial)

Recruiting at 544 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Uncontrolled hypertension, Heart failure, Malignancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 years

8323 Participants Needed

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.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

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

Exclusion Criteria

I have a serious kidney condition.

Platelet count ≤LLN

My heart condition severely limits my physical activity.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly subcutaneous injections of TQJ230 or placebo

4 years

Monthly visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Pelacarsen (TQJ230)

Trial Overview The 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

Group I: TQJ230 Experimental Treatment 1 Intervention

TQJ230 80 mg injected monthly administered subcutaneously

Group II: Placebo Placebo Group 1 Intervention

Monthly subcutaneous injections.

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD