Pelacarsen for Cardiovascular Disease

(ADD-VANTAGE Trial)

Recruiting at 7 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must be taking: Inclisiran

Must not be taking: PCSK9 inhibitors

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: 12

Duration: 6 months

340 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C).

Are You a Good Fit for This Trial?

This trial is for people with cardiovascular disease who have high levels of a fat-protein particle called Lp(a) and are already taking Inclisiran for high LDL cholesterol. They must have stable heart disease, stroke history, or blocked arteries and be on consistent lipid-lowering therapy and other treatments for related conditions like hypertension or diabetes.

Inclusion Criteria

I completed the initial treatment phase with inclisiran.

My Lp(a) levels are 175 nmol/L or higher.

My LDL cholesterol level is above 70 mg/dL.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either pelacarsen or placebo subcutaneous injections once monthly

6 months

6 visits (in-person)

Open-label Treatment

All participants receive pelacarsen 80 mg injection once monthly

6 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Inclisiran
• Pelacarsen

Trial Overview The study tests the effectiveness of Pelacarsen compared to a placebo in lowering Lp(a) levels among participants with established arterial plaque buildup who are also receiving Inclisiran. The goal is to see if adding Pelacarsen can further reduce cardiovascular risks.

How Is the Trial Designed?

Group I: Pelacarsen Active Control 2 Interventions

Participants randomized in Pelacarsen arm, will be administered pelacarsen (TQJ230) subcutaneous injection once monthly for 12 months.

Group II: Placebo Placebo Group 3 Interventions

Participants will be administered placebo subcutaneous injection once monthly for 6 months. After Month 6, all participants will receive pelacarsen 80 mg injection for the remaining 6 months during the open-label treatment period.

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