NCT06813911 Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
| NCT ID | NCT06813911 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Atherosclerotic Cardiovascular Disease (ASCVD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 340 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2028-02-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 340 participants in total. It began in 2025-04-30 with a primary completion date of 2028-02-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT06813911 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Atherosclerotic Cardiovascular Disease (ASCVD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06813911 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 340 participants.
Is NCT06813911 currently recruiting?
Yes, NCT06813911 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06813911 trial being conducted?
This trial is being conducted at Birmingham, United States, Sun City West, United States, Beverly Hills, United States, West Hills, United States and 11 additional locations.
Who is sponsoring the NCT06813911 clinical trial?
NCT06813911 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 340 participants.