Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
Condition(s) studied
Investigational drug(s) / intervention(s)
Pelacarsen: Pelacarsen will be provided as solution for injection in prefilled syringe 80 mg for subcutaneous injection.
Placebo: Placebo will be provided as solution for injection in prefilled syringe for subcutaneous injection.
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.
Study 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).
Eligibility
Primary outcome measure(s)
- Change in log transformed lipoprotein A (Lp(a)) concentration — 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
Trial sites (94)
| Facility | City | Region | Status |
|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | |
| Clinical Research Inst of Arizona | Sun City West | Arizona | |
| National Heart Institute | Beverly Hills | California | |
| Interv Cardiology Med Grp | West Hills | California | |
| Excel Medical Clinical Trials LLC | Boca Raton | Florida | |
| Jacksonville Center for Clinical | Jacksonville | Florida | |
| K2 Medical Research LLC | Maitland | Florida | |
| University of Miami Hospital | Miami | Florida | |
| Baptist Health South | Miami | Florida | |
| Inpatient Research Clinical LLC | Miami Lakes | Florida | |
| FXM Clin Res Miramar LLC | Miramar | Florida | |
| Ocala Cardiovascular Research | Ocala | Florida | |
| SEC Clinical Research | Pensacola | Florida | |
| Peace River Cardiovascular Center | Port Charlotte | Florida | |
| University Of South Florida | Tampa | Florida | |
| FC Site Partners Miami | Winter Park | Florida | |
| Advocate Lutheran General Childrens Hospital | Park Ridge | Illinois | |
| American Health Network Research Dept | Muncie | Indiana | |
| Cardiovascular Associates Research | Covington | Louisiana | |
| Omega Clinical Research | Metairie | Louisiana | |
| Flourish Research Bowie | Bowie | Maryland | |
| Anderson Medical Research | Ft. Washington | Maryland | |
| Henry Ford Hospital | Detroit | Michigan | |
| Aa Mrc Llc | Flint | Michigan | |
| MyMichigan Medical Center Midland | Midland | Michigan | |
| AB Clinical Trials | Las Vegas | Nevada | |
| Overlook Medical Center | Summit | New Jersey | |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | |
| The Corvallis Clinic P C | Corvallis | Oregon | |
| Novartis Investigative Site | Tullahoma | Tennessee | |
| PharmaTex Research LLC | Amarillo | Texas | |
| Kelsey Seybold Research Foundation | Houston | Texas | |
| Northwest Houston Clinical Research PLLC | Tomball | Texas | |
| Intermountain Medical Center | Murray | Utah | |
| Virginia Heart | Falls Church | Virginia | |
| Novartis Investigative Site | Yinchuan | Ningxia | |
| Novartis Investigative Site | Jining | Shandong | |
| Novartis Investigative Site | Xian | Shanxi | |
| Novartis Investigative Site | Beijing | China | |
| Novartis Investigative Site | Shanghai | China |
+ 54 more sites — see the full list on the official registry below.
On this site
📄 Leqvio (inclisiran) drug profile →More Novartis Pharmaceuticals trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06813911 on ClinicalTrials.gov ↗ ← All trials in Italy