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Lp(a) lowering study of pelacarsen (TQJ230) with background inclisiran in participants with elevated Lp(a) and established ASCVD
EU CTIS ID: 2024-516356-18-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Prior treatment with inclisiran
- 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
- Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit
- Uncontrolled hypertension at Randomization/Baseline visit
See the full eligibility 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
- Prior treatment with inclisiran
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- China
- Taiwan
- United Kingdom
- Hong Kong
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Taiwan; United Kingdom; Hong Kong; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.