A Phase II Study to Evaluate the Safety and Efficacy of SAL003 Combined With Atorvastatin in Hype… (NCT07278830) | Clinical Trial Compass
CompletedPhase 2
A Phase II Study to Evaluate the Safety and Efficacy of SAL003 Combined With Atorvastatin in Hypercholesterolemia and Mixed Dyslipidemia
China214 participantsStarted 2023-06-02
Plain-language summary
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of SAL003, a recombinant fully human anti-PCSK9 monoclonal antibody, in combination with a stable dose of atorvastatin in patients with hypercholesterolemia and mixed dyslipidemia.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subjects aged 18 to 75 years.
✓. Diagnosis of hypercholesterolemia and/or mixed dyslipidemia per the 2016 Chinese guidelines.
✓. On a stable statin regimen as defined by the two pathways:
✕. Suffering from homozygous familial hypercholesterolemia (HoFH); Other diseases that may cause secondary increase of LDL-C: Cushing's syndrome, nephrotic syndrome, myeloma, glycogen storage disease, systemic lupus erythematosus, acute intermittent porphyria;
✕. Route 1: The medication compliance of atorvastatin during the induction period is less than 80% or more than 120%; Route 2: The medication compliance of atorvastatin within 28 days before screening is less than 80% or more than 120%;
✕. Within 3 months before screening, there is heart failure (NYHA cardiac function classification of grade III and IV), acute coronary syndrome, percutaneous coronary intervention, or other serious heart diseases \[such as cardiogenic shock, grade II-III atrioventricular block, bradycardia (heart rate \< 50 beats/minute), other serious arrhythmias, etc.\];
✕. Within 3 months before screening, there is a serious cerebrovascular disease (hypertensive encephalopathy, cerebral vascular injury, stroke, transient ischemic attack, etc.), or there is a serious aortic or peripheral vascular lesion, or there are indications for surgical intervention;
What they're measuring
1
Percent change of Low-Density Lipoprotein Cholesterol (LDL-C)
✕. Within 3 months before screening, there is a major surgical history or plans to undergo major surgery during the study period;
✕. Patients with poorly controlled hypertension (SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg);
✕. Diabetic patients with the following conditions known: 1) Type 1 diabetic patients; 2) Type 2 diabetic patients with poor blood sugar control (HbA1c \> 8.0%);
✕. Patients with active viral hepatitis (including hepatitis B and hepatitis C), other severe liver diseases, or liver dysfunction (ALT or AST \> 2.5 times the upper limit of normal, TBIL \> 2 times the upper limit of normal);