🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT06813911
Recruiting Phase 3

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

NCT06813911 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2025-04-30
Last updated
2026-08-07

Condition(s) studied

Atherosclerotic Cardiovascular Disease (ASCVD)

Investigational drug(s) / intervention(s)

PelacarsenPlaceboInclisiran

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (95)

FacilityCityRegionStatus
Parkway Medical Center Birmingham Alabama Active Not Recruiting
Clinical Research Inst of Arizona Sun City West Arizona Active Not Recruiting
National Heart Institute Beverly Hills California Active Not Recruiting
Interv Cardiology Med Grp West Hills California Active Not Recruiting
Excel Medical Clinical Trials LLC Boca Raton Florida Active Not Recruiting
Jacksonville Center for Clinical Jacksonville Florida Recruiting
K2 Medical Research LLC Maitland Florida Active Not Recruiting
University of Miami Hospital Miami Florida Active Not Recruiting
Baptist Health South Miami Florida Recruiting
Inpatient Research Clinical LLC Miami Lakes Florida Active Not Recruiting
FXM Clin Res Miramar LLC Miramar Florida Active Not Recruiting
Ocala Cardiovascular Research Ocala Florida Recruiting
SEC Clinical Research Pensacola Florida Recruiting
Peace River Cardiovascular Center Port Charlotte Florida Recruiting
University Of South Florida Tampa Florida Recruiting
FC Site Partners Miami Winter Park Florida Recruiting
Advocate Lutheran General Childrens Hospital Park Ridge Illinois Recruiting
American Health Network Research Dept Muncie Indiana Recruiting
American Health Network Research Dept Muncie Indiana Recruiting
Cardiovascular Associates Research Covington Louisiana Active Not Recruiting
Omega Clinical Research Metairie Louisiana Recruiting
Flourish Research Bowie Bowie Maryland Recruiting
Anderson Medical Research Ft. Washington Maryland Recruiting
Henry Ford Hospital Detroit Michigan Active Not Recruiting
Aa Mrc Llc Flint Michigan Active Not Recruiting
MyMichigan Medical Center Midland Midland Michigan Active Not Recruiting
AB Clinical Trials Las Vegas Nevada Active Not Recruiting
Overlook Medical Center Summit New Jersey Recruiting
Wake Forest University Baptist Medical Center Winston-Salem North Carolina Recruiting
The Corvallis Clinic P C Corvallis Oregon Active Not Recruiting
Novartis Investigative Site Tullahoma Tennessee Recruiting
PharmaTex Research LLC Amarillo Texas Recruiting
Kelsey Seybold Research Foundation Houston Texas Recruiting
Northwest Houston Clinical Research PLLC Tomball Texas Recruiting
Intermountain Medical Center Murray Utah Recruiting
Virginia Heart Falls Church Virginia Recruiting
Novartis Investigative Site Yinchuan Ningxia Active Not Recruiting
Novartis Investigative Site Jining Shandong Recruiting
Novartis Investigative Site Xian Shanxi Recruiting
Novartis Investigative Site Beijing China Recruiting

+ 55 more sites — see the full list on the official registry below.

Official registry record

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 the UK