Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD (ADD-VANTAGE)

August 6, 2026 updated by: Novartis Pharmaceuticals

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 (ASCVD), and Elevated LDL-C and Lp(a)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study followed by an open-label treatment period.

Study Type

Interventional

Enrollment (Estimated)

340

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Novartis Investigative Site
      • Shanghai, China, 200025
        • Recruiting
        • Novartis Investigative Site
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Active, not recruiting
        • Novartis Investigative Site
    • Shandong
      • Jining, Shandong, China, 272000
        • Recruiting
        • Novartis Investigative Site
    • Shanxi
      • Xian, Shanxi, China, 710061
        • Recruiting
        • Novartis Investigative Site
  • France
      • Béziers, France, 34525
        • Recruiting
        • Novartis Investigative Site
      • Cholet, France, 49325
        • Recruiting
        • Novartis Investigative Site
      • Grenoble, France, 38043
        • Active, not recruiting
        • Novartis Investigative Site
      • Lille, France, 59037
        • Recruiting
        • Novartis Investigative Site
      • Montpellier, France, 34295
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75013
        • Recruiting
        • Novartis Investigative Site
      • Pessac, France, 33604
        • Recruiting
        • Novartis Investigative Site
      • Poitiers, France, 86021
        • Recruiting
        • Novartis Investigative Site
      • Toulouse, France, 31054
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10789
        • Recruiting
        • Novartis Investigative Site
      • Bielefeld, Germany, 33604
        • Recruiting
        • Novartis Investigative Site
      • Gelnhausen, Germany, 63571
        • Recruiting
        • Novartis Investigative Site
      • Mannheim, Germany, 68165
        • Recruiting
        • Novartis Investigative Site
      • Münster, Germany, 48145
        • Recruiting
        • Novartis Investigative Site
      • Singen, Germany, 78224
        • Recruiting
        • Novartis Investigative Site
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Germany, 70376
        • Recruiting
        • Novartis Investigative Site
    • Brandenburg
      • Potsdam, Brandenburg, Germany, 14473
        • Recruiting
        • Novartis Investigative Site
    • Saxony
      • Chemnitz, Saxony, Germany, 09113
        • Recruiting
        • Novartis Investigative Site
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Novartis Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Recruiting
        • Novartis Investigative Site
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong, 999077
        • Recruiting
        • Novartis Investigative Site
  • Italy
    • AN
      • Ancona, AN, Italy, 60020
        • Recruiting
        • Novartis Investigative Site
    • CE
      • Caserta, CE, Italy, 81100
        • Recruiting
        • Novartis Investigative Site
    • GR
      • Grosseto, GR, Italy, 58100
        • Recruiting
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20138
        • Recruiting
        • Novartis Investigative Site
      • Rozzano, MI, Italy, 20089
        • Recruiting
        • Novartis Investigative Site
    • PG
      • Perugia, PG, Italy, 06129
        • Recruiting
        • Novartis Investigative Site
    • PN
      • Pordenone, PN, Italy, 33170
        • Recruiting
        • Novartis Investigative Site
    • SA
      • Salerno, SA, Italy, 84131
        • Recruiting
        • Novartis Investigative Site
    • VR
      • Legnago, VR, Italy, 37045
        • Recruiting
        • Novartis Investigative Site
  • Netherlands
      • Enschede, Netherlands, 7512KZ
        • Recruiting
        • Novartis Investigative Site
    • South Holland
      • The Hague, South Holland, Netherlands, 2545 AA
        • Recruiting
        • Novartis Investigative Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Active, not recruiting
        • Latin Clinical Trial Center Inc
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Novartis Investigative Site
      • Barcelona, Spain, 08023
        • Recruiting
        • Novartis Investigative Site
      • Córdoba, Spain, 14004
        • Recruiting
        • Novartis Investigative Site
      • Huelva, Spain, 21080
        • Recruiting
        • Novartis Investigative Site
      • Las Palmas GC, Spain, 35010
        • Recruiting
        • Novartis Investigative Site
      • Salamanca, Spain, 37007
        • Recruiting
        • Novartis Investigative Site
      • Valencia, Spain, 46010
        • Recruiting
        • Novartis Investigative Site
      • Valencia, Spain, 46014
        • Recruiting
        • Novartis Investigative Site
    • A Coruna
      • Santiago Compostela, A Coruna, Spain, 15706
        • Recruiting
        • Novartis Investigative Site
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Novartis Investigative Site
    • Sevilla
      • Castilleja de la Cuesta, Sevilla, Spain, 41950
        • Recruiting
        • Novartis Investigative Site
  • Taiwan
      • Changhua, Taiwan, 50006
        • Recruiting
        • Novartis Investigative Site
      • Kaohsiung City, Taiwan, 80756
        • Recruiting
        • Novartis Investigative Site
      • Tainan, Taiwan, 704
        • Recruiting
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Active, not recruiting
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Active, not recruiting
        • Novartis Investigative Site
  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, EC1M 6BQ
        • Recruiting
        • Novartis Investigative Site
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Novartis Investigative Site
      • Tyne and Wear, United Kingdom, NE29 8NH
        • Recruiting
        • Novartis Investigative Site
    • West Sussex
      • Chichester, West Sussex, United Kingdom, PO19 6SE
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Active, not recruiting
        • Parkway Medical Center
    • Arizona
      • Sun City West, Arizona, United States, 85375
        • Active, not recruiting
        • Clinical Research Inst of Arizona
    • California
      • Beverly Hills, California, United States, 90211
        • Active, not recruiting
        • National Heart Institute
      • West Hills, California, United States, 91307
        • Active, not recruiting
        • Interv Cardiology Med Grp
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Active, not recruiting
        • Excel Medical Clinical Trials LLC
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Jacksonville Center for Clinical
        • Principal Investigator:
          • Michael J Koren
        • Contact:
      • Maitland, Florida, United States, 32751
        • Active, not recruiting
        • K2 Medical Research LLC
      • Miami, Florida, United States, 33136
        • Active, not recruiting
        • University of Miami Hospital
      • Miami, Florida, United States, 33173
        • Recruiting
        • Baptist Health South
        • Principal Investigator:
          • Adedapo Iluyomade
        • Contact:
      • Miami Lakes, Florida, United States, 33014
        • Active, not recruiting
        • Inpatient Research Clinical LLC
      • Miramar, Florida, United States, 33027
        • Active, not recruiting
        • FXM Clin Res Miramar LLC
      • Ocala, Florida, United States, 34471
      • Pensacola, Florida, United States, 32503
        • Recruiting
        • Sec Clinical Research
        • Principal Investigator:
          • Robert I Garver
        • Contact:
      • Port Charlotte, Florida, United States, 33952
        • Recruiting
        • Peace River Cardiovascular Center
        • Contact:
        • Principal Investigator:
          • David Allan Hotchkiss
      • Tampa, Florida, United States, 33612
        • Recruiting
        • University of South Florida
        • Contact:
        • Principal Investigator:
          • Shone Almeida
      • Winter Park, Florida, United States, 32789
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Lutheran General Childrens Hospital
        • Principal Investigator:
          • Adib Chaus
        • Contact:
    • Indiana
      • Muncie, Indiana, United States, 47304
        • Recruiting
        • American Health Network Research Dept
        • Principal Investigator:
          • Andrew Daluga
        • Contact:
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Active, not recruiting
        • Cardiovascular Associates Research
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • Omega Clinical Research
        • Principal Investigator:
          • Tuan-Huy Tran
        • Contact:
    • Maryland
      • Bowie, Maryland, United States, 20715
      • Ft. Washington, Maryland, United States, 20744
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Active, not recruiting
        • Henry Ford Hospital
      • Flint, Michigan, United States, 48504
        • Active, not recruiting
        • Aa Mrc Llc
      • Midland, Michigan, United States, 48670
        • Active, not recruiting
        • MyMichigan Medical Center Midland
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Active, not recruiting
        • AB Clinical Trials
    • New Jersey
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Active, not recruiting
        • The Corvallis Clinic P C
    • Tennessee
      • Tullahoma, Tennessee, United States, 37388
        • Recruiting
        • Novartis Investigative Site
        • Principal Investigator:
          • Dinesh Gupta
        • Contact:
    • Texas
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • PharmaTex Research LLC
        • Principal Investigator:
          • David Brabham
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Kelsey Seybold Research Foundation
        • Principal Investigator:
          • Fisayomi Shobayo
        • Contact:
      • Tomball, Texas, United States, 77375
        • Recruiting
        • Northwest Houston Clinical Research PLLC
        • Principal Investigator:
          • Shamaila Aslam
        • Contact:
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Principal Investigator:
          • Jeffrey Anderson
        • Contact:
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Virginia Heart
        • Principal Investigator:
          • Tariq Haddad
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion criteria:

  • Male and female participants 18 to ≤80 years of age at Screening visit
  • Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) at Screening visit
  • On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit
  • Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized
  • On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to Randomization/Baseline visit
  • Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit
  • Central laboratory reported LDL-C >70 mg/dL (or >1.8 mmol/L) at Screening visit

Key Exclusion Criteria:

  • Prior treatment with inclisiran
  • Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit
  • Uncontrolled hypertension at Randomization/Baseline visit
  • Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1)
  • Triglycerides ≥400 mg/dL at Screening visit
  • History of malignancy of any organ system within the past 5 years
  • Myocardial infarction, stroke or other major bleeding, coronary or lower limb re vascularization, major cardiac or non-cardiac surgery between Screening visit and Randomization/Baseline visit (Day 1)
  • Central laboratory reported platelet count <140,000 per mm3
  • Active liver disease or hepatic dysfunction at Screening visit
  • Significant kidney disease at Screening visit
  • Pregnant or nursing women at Screening visit

  • Any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at Screening visit

    • Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pelacarsen
Participants randomized in Pelacarsen arm, will be administered pelacarsen (TQJ230) subcutaneous injection once monthly for 12 months.
Drug: Pelacarsen
Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection.
Other Names:
  • TQJ230
Drug: Inclisiran
All participants will be administered two loading doses of inclisiran as background treatment at Run-in 1 and Run-in 2, separated by 3 months, according to the approved label. After that inclisiran will be administered every 6 months, i.e., Month 5 and Month 11.
Placebo Comparator: Placebo
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.
Drug: Pelacarsen
Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection.
Other Names:
  • TQJ230
Drug: Inclisiran
All participants will be administered two loading doses of inclisiran as background treatment at Run-in 1 and Run-in 2, separated by 3 months, according to the approved label. After that inclisiran will be administered every 6 months, i.e., Month 5 and Month 11.
Drug: Placebo
Placebo will be provided as solution for injection in prefilled syringe for subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in log transformed lipoprotein A (Lp(a)) concentration
Time Frame: Baseline, 6 Months
To evaluate the efficacy of Pelacarsen compared to placebo, in reducing Lp(a) levels at Month 6 in ASCVD participants who have elevated Lp(a), and who are on background inclisiran for elevated LDL-C
Baseline, 6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving reduction in Lp(a) levels at Month 6
Time Frame: Baseline, Month 6
Efficacy of pelacarsen versus placebo in reducing Lp(a)
Baseline, Month 6
Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
Time Frame: 16 Months
The TEAEs will be defined as any recorded AE with start date located in the on-treatment period. To understand the effect of pelacarsen versus placebo on safety and tolerability in participants treated with background inclisiran. Incidence and severity of AEs by treatment group, including changes in the vital signs, electrocardiogram and laboratory results qualifying and reported as AEs.
16 Months
Incidence of treatment emergent adverse events of special interest (AESI)
Time Frame: 12 Months
To understand the effect of pelacarsen versus placebo on safety and tolerability in participants treated with background inclisiran
12 Months
Incidence of study and treatment discontinuations due to TEAEs
Time Frame: 12 Months
Incidence proportion of study discontinuations due to TEAEs
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2025

Primary Completion (Estimated)

February 3, 2028

Study Completion (Estimated)

February 29, 2028

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 6, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTQJ230A12304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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