A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of SYH2070 Injection in Participants With Mixed Hyperlipidemia
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;
• Weight index range: 18.5 kg/m2 ≤ BMI ≤ 40.0 kg/m2 at screening;
• Understand the trial procedures and methods, voluntarily participate in this trial and sign the ICF in person;
• Male participants with reproductive capacity and their partners who are reproductive-aged women must agree to use highly effective contraceptive measures during the trial period and 24 weeks after the last administration of the trial drug; serum pregnancy tests before medication, serum or urine pregnancy tests during the trial period must be negative, and not be in the lactation period; participants are not allowed to donate sperm or eggs during the trial period and 24 weeks after the last administration of the trial drug.