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New treatment option for Atherosclerotic Cardiovascular Disease (ASCVD)
Official title Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
ClinicalTrials.gov ID: NCT06813911
What this study is testing
What is Pelacarsen?
Pelacarsen is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for atherosclerotic cardiovascular disease (ascvd).
Also referred to as TQJ230.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
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...
- 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 assigned by chance
- On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to...
You likely can't join if
- 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
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 assigned by chance
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Sun City West, Arizona, United States
- Beverly Hills, California, United States
- West Hills, California, United States
- Boca Raton, Florida, United States
- Jacksonville, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Miramar, Florida, United States
- Ocala, Florida, United States
- Pensacola, Florida, United States
- Port Charlotte, Florida, United States
- Tampa, Florida, United States
- Winter Park, Florida, United States
- Park Ridge, Illinois, United States
- Muncie, Indiana, United States
- Covington, Louisiana, United States
- Metairie, Louisiana, United States
- Bowie, Maryland, United States
+ 70 more site(s).
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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Sun City West, Arizona, United States; Beverly Hills, California, United States; West Hills, California, United States; Boca Raton, Florida, United States; Jacksonville, Florida, United States and 84 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.