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

Novartis

Status and phase: Enrolling; Phase 3

Conditions: Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease

Treatments: Drug: TQJ230; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06267560

CTQJ230A12303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

TQJ230

Experimental group

Description:

TQJ230 80mg QM s.c.

Treatment:

Drug: TQJ230

Placebo

Placebo Comparator group

Description:

Matching placebo.

Treatment:

Drug: Placebo