Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD
- Conditions
- Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT06267560
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 423
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TQJ230 TQJ230 TQJ230 80mg QM s.c. Placebo Placebo Matching placebo.
- Primary Outcome Measures
Name Time Method Change in log-transformed Lp(a) concentration from baseline at week 52 Baseline, 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.
- Secondary Outcome Measures
Name Time Method Incidence proportion of study discontinuations due to TEAEs Up to 52 weeks Incidence proportion of study discontinuations due to TEAEs will be provided
Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest Up to 52 weeks Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest will be provided
Trial Locations
- Locations (104)
Synexus Clinical Research Advantage
🇺🇸Birmingham, Alabama, United States
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
Optimal Research LLC
🇺🇸Huntsville, 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
Hope Clinical Research
🇺🇸Canoga Park, California, United States
Valley Clinical Trials Inc
🇺🇸Covina, California, United States
NICRs Research Center
🇺🇸Garden Grove, California, United States
University of Calif Irvine Med Cntr
🇺🇸Irvine, California, United States
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