Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Atherosclerotic Cardiovascular Disease (ASCVD), and Elevated LDL-C and Lp(a)
Sponsor: Novartis Pharmaceuticals
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Change in log transformed lipoprotein A (Lp(a)) concentration
Time frame: Baseline, 6 Months
Secondary Endpoints
Proportion of participants achieving reduction in Lp(a) levels at Month 6
Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
Incidence of treatment emergent adverse events of special interest (AESI)
Eligibility Criteria
Key Inclusion criteria: * Male and female participants 18 to ≤80 years of age at Screening visit * Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) at Screening visit * On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit * Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized * On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to Randomization/Baseline visit * Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit * Central laboratory reported LDL-C \>70 mg/dL (or \>1.8 mmol/L) at Screening visit Key Exclusion Criteria: * Prior treatment with inclisiran * Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit * Uncontrolled hypertension a…
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Expert commentary on why this trial matters and what to watch for.
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