CTQJ230A1US13 is a randomized, double-blind, placebo-controlled, multicenter phase IIIb study designed to evaluate the efficacy, safety, tolerability, and coronary plaque effects of early pelacarsen (TQJ230) initiation in participants with elevated Lp(a) and recent acute coronary syndrome (ACS).
This study consists of Lp(a) measurement and additional screening assessments, a double-blind treatment period of 18 months, and a 16-week safety follow up period from the last dose. Efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo will be assessed throughout the study, with primary analysis at Day 180 and final analysis at Day 540.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
Pelacarsen 80 mg subcutaneously (s.c.) once a month (QM)
Placebo subcutaneously (s.c.) once a month (QM)
Change in log-transformed Lp(a) concentration
Change in log-transformed Lipoprotein A (Lp(a)) concentration from baseline to Day 180
Time frame: Baseline, Day 180
Proportion of participants with Lp(a) < 105 nmol/L
Proportion of participants with Lipoprotein A (Lp(a)) \< 105 nmol/L
Time frame: Day 180 and Day 540
Proportion of participants with TEAEs, TESAEs,TEAEs or TESAEs leading to study drug discontinuation and TEAEs of special interest
Proportion of participants with: * Treatment-emergent adverse events (TEAEs) * Treatment-emergent serious adverse events (TESAEs) * TEAEs or TESAEs leading to study drug discontinuation * TEAEs of special interest
Time frame: 22 months
Summary of observed values for Glomerular Filtration Rate (GFR)
Summary of observed values in GFR (Safety laboratory parameters)
Time frame: Up to 18 months
Change from baseline in Glomerular Filtration Rate (GFR)
Change from baseline in GFR (Safety laboratory parameters)
Time frame: Baseline and up to 18 months
Summary of observed values for Heart Rate (HR)
Summary of observed values for HR (electrocardiogram)
Time frame: Up to 18 months
Change from baseline in Heart Rate (HR)
Change from baseline in HR (electrocardiogram)
Time frame: Baseline and up to 18 months
Novartis Pharmaceuticals
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Summary of observed values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Summary of observed values for SBP and DBP (vital signs)
Time frame: Up to 18 months
Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change from baseline in SBP and DBP (vital signs)
Time frame: Baseline and up to 18 months
Change from baseline to Day 540 in non-calcified coronary plaque volume
Change from baseline to Day 540 in non-calcified coronary plaque volume, as assessed by CCTA
Time frame: Baseline and Day 540