A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hyp… (NCT07421232) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
China156 participantsStarted 2024-12-03
Plain-language summary
The purpose of this study is to compare the effectiveness, safety of SYH2053 in Participants with primary hypercholesterolemia or mixed dyslipidemia.
A total of 156 Participants were actually enrolled
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age of 18 - 75 years (inclusive);
✓. Participants with primary hypercholesterolemia or mixed dyslipidemia who have maintained a low-fat diet for at least 4 weeks prior to screening. Additionally, meet one of the following criteria:
✓. According to local laboratory results, low-density lipoprotein cholesterol (LDL-C) level ≥100 mg/dL(2.6 mmol/L) and fasting triglycerides ≤400 mg/dL (4.5 mmol/L);
✓. Participants must understand of the study protocol, including the nature of the intervention and potential adverse events, and must provide voluntary, written informed consent before enrollment;
✓. Participants are able to establish good communication with the investigator and complete the trial in accordance with the protocol.
Exclusion criteria
✕. Participants with severe allergic diseases or an allergic constitution (allergies to three or more drugs or foods) or allergic to oligonucleotide drugs；
✕. History of treatment with PCSK9-targeted antibody therapies or PCSK9-targeted oligonucleotide therapies;
✕. History of malignancy within 5 years (excluding treated basal cell carcinoma of the skin), or presence of a suspected malignancy currently being evaluated by the investigator;
✕. Systolic blood pressure (SBP) \> 180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg during the Screening Period or prior to Randomization (repeat measurement allowed once);
✕. History of severe cardiovascular or cerebrovascular disease (e.g., hypertensive encephalopathy, acute stroke, transient ischemic attack, acute myocardial infarction, severe arrhythmia, etc.) within 6 months prior to Screening or prior to Randomization; or presence of severe aortic or peripheral vascular disease; or presence of conditions requiring surgical intervention; history of major surgery within 6 months prior to Screening or prior to Randomization; or plans for major surgery during the study period;
✕. History of heart failure with NYHA Class III-IV, or LVEF \< 40% at Screening Period;
✕. eGFR \< 30 mL/min/1.73 m² at Screening Period;
✕. Presence of severe thyroid disease (except for subjects on a stable dose of thyroid hormone replacement therapy or anti-thyroid medication for at least 6 months prior to Screening or Randomization);