Study Description
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. CTQJ230A12303 is a randomized, double-blind, placebo-controlled, multi-center, Phase IIIb
study to evaluate the efficacy ( measured by reduction of the Lp(a) levels) and safety of
pelacarsen (TQJ230) 80mg s.c. QM compared to placebo in US Black/African American and US
Hispanic participants, with established atherosclerotic cardiovascular disease (ASCVD) as
evidenced by history of coronary heart disease, cerebrovascular disease or symptomatic
peripheral artery disease (PAD) and elevated levels of Lp(a).
The study will consist of a screening period of approximately 30 days, followed by a
Guideline recommended SoC implementation period of approximately 30 days, if required,
and a doubleblind treatment period of 12 months. There will be a post-treatment follow-up
period of 16 weeks.
Interventions
Placebo
TQJ230
Eligibility Criteria
Inclusion Criteria:
- Male and female US Black/African American and US Hispanic participants 18 to ≤ 80
years of age
- Lp(a) ≥ 125 nmol/L at the screening visit, measured at the Central laboratory
- On Standard of Care (SoC) therapy for risk factors other than Lp(a), including LDL-C
(LDL-C lowering therapy dose stable for at least 30 days), elevated blood pressure
and diabetes, at the randomization visit according to local practice/guidelines.
- Established ASCVD disease defined as documented:
- Coronary heart disease (CHD) and/or
- Cerebrovascular disease (CVD) and/or
- Peripheral arterial disease (PAD):
Exclusion Criteria:
- Uncontrolled hypertension
- Heart failure New York Heart Association (NYHA) class IV
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Platelet count <140,000 per mm3
- Active liver disease or hepatic dysfunction
- Significant kidney disease
- Pregnant or nursing women
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