Atherosclerotic Cardiovascular Disease (ASCVD)Phase 3ADD-VANTAGENCT06813911
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
A Phase 3 study testing Pelacarsen and Inclisiran in people with Atherosclerotic Cardiovascular Disease (ASCVD), run by Novartis Pharmaceuticals at 94 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease (ASCVD)
- What is being tested?
- Pelacarsen and Inclisiran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 94 sitesin 11 countries
- Study dates
- 30 Apr 2025to 29 Feb 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
94 sites in 11 countries.
94 sites in 11 countries
United States35 sites
PharmaTex Research LLC
Amarillo, Texas, 79106
National Heart Institute
Beverly Hills, California, 90211
Parkway Medical Center
Birmingham, Alabama, 35215
Excel Medical Clinical Trials LLC
Boca Raton, Florida, 33434
Flourish Research Bowie
Bowie, Maryland, 20715
The Corvallis Clinic P C
Corvallis, Oregon, 97330
Cardiovascular Associates Research
Covington, Louisiana, 70433
Henry Ford Hospital
Detroit, Michigan, 48202
Virginia Heart
Falls Church, Virginia, 22042
Aa Mrc Llc
Flint, Michigan, 48504
Anderson Medical Research
Ft. Washington, Maryland, 20744
Kelsey Seybold Research Foundation
Houston, Texas, 77030
Jacksonville Center for Clinical
Jacksonville, Florida, 32216
AB Clinical Trials
Las Vegas, Nevada, 89119
K2 Medical Research LLC
Maitland, Florida, 32751
Omega Clinical Research
Metairie, Louisiana, 70006
University of Miami Hospital
Miami, Florida, 33136
Baptist Health South
Miami, Florida, 33173
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014
MyMichigan Medical Center Midland
Midland, Michigan, 48670
FXM Clin Res Miramar LLC
Miramar, Florida, 33027
American Health Network Research Dept
Muncie, Indiana, 47304
Intermountain Medical Center
Murray, Utah, 84107
Ocala Cardiovascular Research
Ocala, Florida, 34471
Advocate Lutheran General Childrens Hospital
Park Ridge, Illinois, 60068
SEC Clinical Research
Pensacola, Florida, 32503
Peace River Cardiovascular Center
Port Charlotte, Florida, 33952
Overlook Medical Center
Summit, New Jersey, 07901
Clinical Research Inst of Arizona
Sun City West, Arizona, 85375
University Of South Florida
Tampa, Florida, 33612
Northwest Houston Clinical Research PLLC
Tomball, Texas, 77375
Novartis Investigative Site
Tullahoma, Tennessee, 37388
Interv Cardiology Med Grp
West Hills, California, 91307
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
FC Site Partners Miami
Winter Park, Florida, 32789
Spain11 sites
Novartis Investigative Site
A Coruña, 15006
Novartis Investigative Site
Barcelona, 08023
Novartis Investigative Site
Castilleja de la Cuesta, Sevilla, 41950
Novartis Investigative Site
Córdoba, 14004
Novartis Investigative Site
Huelva, 21080
Novartis Investigative Site
Las Palmas GC, 35010
Novartis Investigative Site
Pamplona, Navarre, 31008
Novartis Investigative Site
Salamanca, 37007
Novartis Investigative Site
Santiago Compostela, A Coruna, 15706
Novartis Investigative Site
Valencia, 46010
Novartis Investigative Site
Valencia, 46014
Germany10 sites
Novartis Investigative Site
Berlin, 10789
Novartis Investigative Site
Bielefeld, 33604
Novartis Investigative Site
Chemnitz, Saxony, 09113
Novartis Investigative Site
Gelnhausen, 63571
Novartis Investigative Site
Leipzig, Saxony, 04103
Novartis Investigative Site
Mannheim, 68165
Novartis Investigative Site
Münster, 48145
Novartis Investigative Site
Potsdam, Brandenburg, 14473
Novartis Investigative Site
Singen, 78224
Novartis Investigative Site
Stuttgart, Baden-Wurttemberg, 70376
France9 sites
Novartis Investigative Site
Béziers, 34525
Novartis Investigative Site
Cholet, 49325
Novartis Investigative Site
Grenoble, 38043
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Montpellier, 34295
Novartis Investigative Site
Paris, 75013
Novartis Investigative Site
Pessac, 33604
Novartis Investigative Site
Poitiers, 86021
Novartis Investigative Site
Toulouse, 31054
Italy9 sites
Novartis Investigative Site
Ancona, AN, 60020
Novartis Investigative Site
Caserta, CE, 81100
Novartis Investigative Site
Grosseto, GR, 58100
Novartis Investigative Site
Legnago, VR, 37045
Novartis Investigative Site
Milan, MI, 20138
Novartis Investigative Site
Perugia, PG, 06129
Novartis Investigative Site
Pordenone, PN, 33170
Novartis Investigative Site
Rozzano, MI, 20089
Novartis Investigative Site
Salerno, SA, 84131
China5 sites
Novartis Investigative Site
Beijing, 100730
Novartis Investigative Site
Jining, Shandong, 272000
Novartis Investigative Site
Shanghai, 200025
Novartis Investigative Site
Xian, Shanxi, 710061
Novartis Investigative Site
Yinchuan, Ningxia, 750004
Taiwan5 sites
Novartis Investigative Site
Changhua, 50006
Novartis Investigative Site
Kaohsiung City, 80756
Novartis Investigative Site
Tainan, 704
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taipei, 11217
United Kingdom5 sites
Novartis Investigative Site
Chichester, West Sussex, PO19 6SE
Novartis Investigative Site
London, EC1M 6BQ
Novartis Investigative Site
London, W12 0HS
Novartis Investigative Site
Manchester, M13 9WL
Novartis Investigative Site
Tyne and Wear, NE29 8NH
Hong Kong2 sites
Novartis Investigative Site
Hong Kong, Hong Kong, 999077
Novartis Investigative Site
Hong Kong, 999077
Netherlands2 sites
Novartis Investigative Site
Enschede, 7512KZ
Novartis Investigative Site
The Hague, South Holland, 2545 AA
About this study
Official title: 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 has been terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint
Read the detailed description
This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study followed by an open-label treatment period.
- Being tested
- Pelacarsen, Placebo, Inclisiran
- Keywords
- Lipoprotein(a), cardiovascular disease, ASCVD, pelacarsen (TQJ230)
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PelacarsenDrug
Also called TQJ230
Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection.
PlaceboDrug
Placebo will be provided as solution for injection in prefilled syringe for subcutaneous injection.
InclisiranDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Pelacarsen | Active comparator | Participants randomized in Pelacarsen arm, will be administered pelacarsen (TQJ230) subcutaneous injection once monthly for 12 months. Receives: Drug: Pelacarsen; Drug: Inclisiran |
| Placebo | Placebo comparator | 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. Receives: Drug: Pelacarsen; Drug: Placebo; Drug: Inclisiran |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 Months
Secondary outcomes (4)
Proportion of participants achieving reduction in Lp(a) levels at Month 6
Efficacy of pelacarsen versus placebo in reducing Lp(a)
Measured: Baseline, Month 6
Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
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.
Measured: 16 Months
Incidence of treatment emergent adverse events of special interest (AESI)
To understand the effect of pelacarsen versus placebo on safety and tolerability in participants treated with background inclisiran
Measured: 12 Months
Incidence of study and treatment discontinuations due to TEAEs
Incidence proportion of study discontinuations due to TEAEs
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start30 Apr 2025
- Primary completion3 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular Disease (ASCVD)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813911
- Sponsor's protocol ID
- CTQJ230A12304
- Acronym
- ADD-VANTAGE
- Status last verified
- Aug 2026
- First submitted
- 3 Feb 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
- Expanded access
- Available