Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
ADD-VANTAGE
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)
1 other identifier
interventional
340
11 countries
92
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2025
Typical duration for phase_3
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2025
CompletedFirst Posted
Study publicly available on registry
February 7, 2025
CompletedStudy Start
First participant enrolled
April 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 29, 2028
April 16, 2026
April 1, 2026
2.8 years
February 3, 2025
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in log transformed lipoprotein A (Lp(a)) concentration
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 Outcomes (4)
Proportion of participants achieving reduction in Lp(a) levels at Month 6
Baseline, Month 6
Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
16 Months
Incidence of treatment emergent adverse events of special interest (AESI)
12 Months
Incidence of study and treatment discontinuations due to TEAEs
12 Months
Study Arms (2)
Pelacarsen
ACTIVE COMPARATORParticipants randomized in Pelacarsen arm, will be administered pelacarsen (TQJ230) subcutaneous injection once monthly for 12 months.
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection.
Placebo will be provided as solution for injection in prefilled syringe for subcutaneous injection.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (92)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
Clinical Research Inst of Arizona
Sun City West, Arizona, 85375, United States
National Heart Institute
Beverly Hills, California, 90211, United States
Interv Cardiology Med Grp
West Hills, California, 91307, United States
Excel Medical Clinical Trials LLC
Boca Raton, Florida, 33434, United States
Jacksonville Center for Clinical
Jacksonville, Florida, 32216, United States
K2 Medical Research LLC
Maitland, Florida, 32751, United States
University of Miami Hospital
Miami, Florida, 33136, United States
Baptist Health South
Miami, Florida, 33173, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014, United States
FXM Clin Res Miramar LLC
Miramar, Florida, 33027, United States
Ocala Cardiovascular Research
Ocala, Florida, 34471, United States
SEC Clinical Research
Pensacola, Florida, 32503, United States
Peace River Cardiovascular Center
Port Charlotte, Florida, 33952, United States
University Of South Florida
Tampa, Florida, 33612, United States
FC Site Partners Miami
Winter Park, Florida, 32789, United States
Advocate Lutheran General Childrens Hospital
Park Ridge, Illinois, 60068, United States
American Health Network Research Dept
Muncie, Indiana, 47304, United States
American Health Network Research Dept
Muncie, Indiana, 47304, United States
Cardiovascular Associates Research
Covington, Louisiana, 70433, United States
Omega Clinical Research
Metairie, Louisiana, 70006, United States
Anderson Medical Research
Ft. Washington, Maryland, 20744, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Aa Mrc Llc
Flint, Michigan, 48504, United States
MyMichigan Medical Center Midland
Midland, Michigan, 48670, United States
AB Clinical Trials
Las Vegas, Nevada, 89119, United States
Overlook Medical Center
Summit, New Jersey, 07901, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
The Corvallis Clinic P C
Corvallis, Oregon, 97330, United States
Novartis Investigative Site
Tullahoma, Tennessee, 37388, United States
PharmaTex Research LLC
Amarillo, Texas, 79106, United States
Kelsey Seybold Research Foundation
Houston, Texas, 77030, United States
Northwest Houston Clinical Research PLLC
Tomball, Texas, 77375, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Virginia Heart
Falls Church, Virginia, 22042, United States
Novartis Investigative Site
Yinchuan, Ningxia, 750004, China
Novartis Investigative Site
Jining, Shandong, 272000, China
Novartis Investigative Site
Xian, Shanxi, 710061, China
Novartis Investigative Site
Beijing, 100730, China
Novartis Investigative Site
Shanghai, 200025, China
Novartis Investigative Site
Béziers, 34525, France
Novartis Investigative Site
Cholet, 49325, France
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Grenoble, 38043, France
Novartis Investigative Site
Lille, 59037, France
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Montpellier, 34295, France
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Paris, 75013, France
Novartis Investigative Site
Pessac, 33604, France
Novartis Investigative Site
Poitiers, 86021, France
Novartis Investigative Site
Toulouse, 31054, France
Novartis Investigative Site
Stuttgart, Baden-Wurttemberg, 70376, Germany
Novartis Investigative Site
Potsdam, Brandenburg, 14473, Germany
Novartis Investigative Site
Chemnitz, Saxony, 09113, Germany
Novartis Investigative Site
Leipzig, Saxony, 04103, Germany
Novartis Investigative Site
Berlin, 10789, Germany
Novartis Investigative Site
Bielefeld, 33604, Germany
Novartis Investigative Site
Gelnhausen, 63571, Germany
Novartis Investigative Site
Mannheim, 68165, Germany
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Münster, 48145, Germany
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Singen, 78224, Germany
Novartis Investigative Site
Hong Kong, Hong Kong, 999077, Hong Kong
Novartis Investigative Site
Hong Kong, 999077, Hong Kong
Novartis Investigative Site
Ancona, AN, 60126, Italy
Novartis Investigative Site
Caserta, CE, 81100, Italy
Novartis Investigative Site
Grosseto, GR, 58100, Italy
Novartis Investigative Site
Milan, MI, 20138, Italy
Novartis Investigative Site
Rozzano, MI, 20089, Italy
Novartis Investigative Site
Perugia, PG, 06129, Italy
Novartis Investigative Site
Legnago, VR, 37045, Italy
Novartis Investigative Site
The Hague, South Holland, 2545 AA, Netherlands
Novartis Investigative Site
Enschede, 7512KZ, Netherlands
Latin Clinical Trial Center Inc
San Juan, 00909, Puerto Rico
Novartis Investigative Site
Santiago Compostela, A Coruna, 15706, Spain
Novartis Investigative Site
Pamplona, Navarre, 31008, Spain
Novartis Investigative Site
Castilleja de la Cuesta, Sevilla, 41950, Spain
Novartis Investigative Site
A Coruña, 15006, Spain
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Barcelona, 08023, Spain
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Córdoba, 14004, Spain
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Huelva, 21080, Spain
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Las Palmas GC, 35010, Spain
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Salamanca, 37007, Spain
Novartis Investigative Site
Valencia, 46010, Spain
Novartis Investigative Site
Valencia, 46014, Spain
Novartis Investigative Site
Changhua, 50006, Taiwan
Novartis Investigative Site
Kaohsiung City, 80756, Taiwan
Novartis Investigative Site
Tainan, 704, Taiwan
Novartis Investigative Site
Taipei, 10002, Taiwan
Novartis Investigative Site
Chichester, West Sussex, PO19 6SE, United Kingdom
Novartis Investigative Site
London, EC1M 6BQ, United Kingdom
Novartis Investigative Site
London, W12 0HS, United Kingdom
Novartis Investigative Site
Manchester, M13 9WL, United Kingdom
Novartis Investigative Site
Tyne and Wear, NE29 8NH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
February 3, 2025
First Posted
February 7, 2025
Study Start
April 30, 2025
Primary Completion (Estimated)
February 3, 2028
Study Completion (Estimated)
February 29, 2028
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.