Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD

Phase 3Active Not RecruitingNCT06267560

Novartis Pharmaceuticals422 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

422

Conditions

Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (101)

Parkway Medical Center

Birmingham, Alabama, United States

Synexus

Glendale, Arizona, United States

Cardiology and Medicine Clinic PA

Little Rock, Arkansas, United States

National Heart Institute

Beverly Hills, California, United States

Alliance Clinical

Canoga Park, California, United States

Outcomes

Primary Outcomes

Change in log-transformed Lp(a) concentration from baseline at week 52

The primary aim of the study is to demonstrate the superiority of pelacarsen to placebo in lowering the Lp(a) level at 12 months of treatment in US Black/African American and US Hispanic participants with established ASCVD and a Lp(a) level of ≥ 125 nmo/L.

Time frame: Baseline, week 52

Secondary Outcomes

Incidence proportion of study discontinuations due to TEAEs

Incidence proportion of study discontinuations due to TEAEs will be provided

Time frame: Up to 52 weeks

Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest

Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest will be provided

Time frame: Up to 52 weeks