NCT06813911 · Novartis Pharmaceuticals
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
(ADD-VANTAGE)
What this study is about
The purpose of the study CTQJ230A12304, is to evaluate the effectiveness, 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).
View original scientific description
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).
Interventions
DRUG
Pelacarsen
Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection.
DRUG
Placebo
Placebo will be provided as solution for injection in prefilled syringe for subcutaneous injection.
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 a
Where
- Birmingham, Alabama
- Sun City West, Arizona
- Beverly Hills, California
- West Hills, California
- Boca Raton, Florida
- Jacksonville, Florida
- Maitland, Florida
- Miami, Florida
- Miami Lakes, Florida
- Miramar, Florida
- Ocala, Florida
- Pensacola, Florida
And 22 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations