This is a randomized, double-blind, placebo-parallel, multicenter phase II clinical trial to evaluate the efficacy and safety of SYH2070 injection in participants with mixed hyperlipidemia.
Age ≥ 18 years old, no gender limitation;
1.7 mmol/L (150 mg/dL) ≤ fasting TG ≤ 5.6 mmol/L (499 mg/dL) at screening;
fasting LDL-C ≥ 2.6 mmol/L (100 mg/dL) at screening;
Participants must have been continuously taking stable medium-intensity or higher statin drugs for at least 4 weeks, accompanied or not by cholesterol absorption inhibitors or fibrates, and maintain the same drug, dosage, frequency and brand throughout the trial period;
Genetic diagnosis or clinical diagnosis indicates homozygous familial hypercholesterolemia;
During the screening or before randomization, there is NYHA-defined heart function grade Ⅲ-Ⅳ or known left ventricular ejection fraction < 30%;
Within 3 months before the screening, there has been a new major cardiovascular adverse event, including acute coronary syndrome (such as myocardial infarction, unstable angina pectoris), cerebrovascular disease history (such as acute stroke or transient ischemic attack), or acute pulmonary embolism;
Within 3 months before the screening, there are clinically significant arrhythmias, such as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular rate, atrial flutter with rapid ventricular rate, third-degree atrioventricular block, sinus arrest, etc.), drug or ablation-induced arrhythmias that cannot be controlled;
Parallel
SYH2070
DrugSYH2070 injection, 150 mg, 300 mg, 400 mg, SC, administration duration: 24 weeks
Placebo
DrugPlacebo, SC, administration duration: 24 weeks
6
Treatment groupsSee each treatment group below.
The percentage change in serum TG levels from baseline at week 24
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