Actively Recruiting
A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholesterolemia or Mixed Hyperlipidemia
Led by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Updated on 2026-04-07
760
Participants Needed
2
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of SYH2053 monotherapy in patients with primary hypercholesterolemia (non-familial) or mixed dyslipidemia . This trial plans to enroll 760 Participants.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholesterolemia or Mixed Hyperlipidemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Fasting LDL-C levels not meeting target criteria based on 2023 Chinese Guidelines for Lipid Management at screening and prior to randomization
- Fasting serum triglycerides less than 500 mg/dL at screening
- Ability to communicate well with the investigator and complete the trial as required
You will not qualify if you...
- Prior diagnosis of familial hypercholesterolemia
- History of diseases causing significant dyslipidemia including Cushing's syndrome, nephrotic syndrome, myeloma, glycogen storage disease, systemic lupus erythematosus, acute intermittent porphyria, cirrhosis, severe biliary obstruction
- History of established atherosclerotic cardiovascular disease including acute coronary syndrome, chronic coronary syndrome, prior coronary revascularization, ischemic stroke, transient ischemic attack, or significant peripheral artery disease
- Use of short-acting lipid-lowering therapies within 90 days or PCSK9 monoclonal antibodies/oral PCSK9 inhibitors within 180 days or RNA-based lipid-lowering therapies within 2 years prior to screening
- History of malignancy within 5 years except treated basal cell carcinoma or current suspected malignancy under evaluation
- Systolic blood pressure over 160 mmHg or diastolic blood pressure over 100 mmHg at screening
- History of heart failure NYHA Class III-IV within 180 days before screening
- Estimated glomerular filtration rate less than 30 mL/min/1.73 m² at screening
- Creatine kinase greater than 3 times upper limit of normal at screening
- Liver enzymes (ALT or AST) greater than 3 times upper limit of normal or total bilirubin greater than 1.5 times upper limit of normal unless due to Gilbert's syndrome
- Prolonged QT/QTcF interval above 450 ms for males or 470 ms for females
- Positive test for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or HIV antibody
- HbA1c greater than 8.0% or diagnosis of type 1 diabetes or gestational diabetes
- History of drug abuse within 5 years
- History of alcohol abuse within 1 year
- Participation in other clinical trials with investigational drugs within 3 months prior to screening or plans to join another trial during this study
- Any condition that may interfere with study conduct or completion as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Affiliation: Peking University Third Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
Affiliation: Peking University Third Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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