Pelacarsen for Cardiovascular Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications. However, you must be on stable therapy for cardiovascular risk factors like LDL-C, blood pressure, and diabetes according to local guidelines.
What makes the drug Pelacarsen unique for treating cardiovascular disease?
Pelacarsen is unique because it is a liver-targeted antisense oligonucleotide specifically designed to lower lipoprotein(a) [Lp(a)] levels, which are a genetic risk factor for cardiovascular disease. Unlike other treatments, it directly targets the LPA gene messenger RNA, offering a novel approach to reducing cardiovascular risk in patients with high Lp(a) levels.12345
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for US Black/African American and Hispanic individuals aged 18 to 80 with high Lp(a) levels and existing cardiovascular disease. They must be on stable standard treatments for other risk factors like LDL cholesterol, blood pressure, and diabetes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pelacarsen (TQJ230) 80 mg s.c. QM or placebo for 52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pelacarsen (TQJ230)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD