Pelacarsen (TQJ230) in US Black/African and Hispanic populations with elevated Lp(a)

UCI Specialty Area: Cardiology

Principal Investigator: Ailin Barseghian Elfarra

Official Title: A randomized double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) in US Black/African American & Hispanic patient populations with elevated Lp(a) and established atherosclerotic cardiovascular disease

A Study On:

Cardiovascular Disease

Study Description

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.

Eligibility

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)

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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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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