NCT07421297
Recruiting
Phase 3
A Phase Ⅲ Randomized, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety of the SYH2053 Subcutaneous Injection as Monotherapy in Participants With Primary Hypercholesterolemia (Non-familial) or Mixed Dyslipidemia
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.3 sites in 1 country760 target enrollmentStarted: February 28, 2026Last updated:
DrugsSYH2053 injection
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 760
- Locations
- 3
- Primary Endpoint
- Percentage change in LDL-C relative to baseline
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •、Age ≥18 years (inclusive);
- •、Fasting serum low-density lipoprotein cholesterol (LDL-C) levels failing to meet the target criteria at screening and prior to randomization (based on local laboratory results). Any one of the following conditions satisfies the criterion(according to the 2023 Chinese Guidelines for Lipid Management):① Low risk: LDL-C ≥130 mg/dL（3.4 mmol/L）and LDL-C\<188 mg/dL（4.9 mmol/L）; ②Moderate risk: LDL-C ≥ 100 mg/dL (2.6 mmol/L) and LDL-C\<188 mg/dL（4.9 mmol/L）; 3、At screening (based on local laboratory results), Fasting serum Triglyceride (TG)\<500 mg/dL（5.6 mmol/L） 4、Participants are able to establish good communication with the investigator and complete the trial in accordance with the protocol.
Exclusion Criteria
- •Prior diagnosis of familial hypercholesterolemia; or a history of the following diseases: Cushing's syndrome, nephrotic syndrome, myeloma, glycogen storage disease, systemic lupus erythematosus, acute intermittent porphyria, cirrhosis, severe biliary obstruction, or other diseases known to significantly cause dyslipidemia；
- •A documented history of established atherosclerotic cardiovascular disease (ASCVD), defined as a history of: acute coronary syndrome (myocardial infarction or unstable angina), chronic coronary syndrome, or prior coronary revascularization (e.g., PCI or CABG); ischemic stroke or transient ischemic attack (TIA); or significant peripheral artery disease (PAD). PAD includes conditions such as chronic limb-threatening ischemia, acute limb ischemia, or atherosclerotic disease in other major arteries (e.g., carotid, vertebral, subclavian, renal, or mesenteric arteries)；
- •Treatment with short-acting lipid-lowering therapies (e.g., statins, fibrates, bempedoic acid, ezetimibe, bile acid sequestrants, niacin, omega-3 fatty acids) or any preparation of unknown composition with lipid-lowering intent (including over-the-counter, traditional, or herbal medicines) within 90 days prior to screening; or treatment with PCSK9 monoclonal antibodies or oral PCSK9 inhibitors within the past 180 days before screening or treatment with inclisiran or any other RNA-based lipid-lowering therapy (e.g., siRNA, antisense oligonucleotide) within the past 2 years before screening;
- •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;
- •At screening, Systolic blood pressure (SBP) \> 160 mmHg or diastolic blood pressure (DBP) \> 100 mmHg（either in untreated patients or in those on stable medical therapy） ;
- •History of heart failure with NYHA Class III-IV within 180days before screening or prior to Randomization;
- •At screening, eGFR \< 30 mL/min/1.73 m²（as calculated by the CKD-EPI equation）;
- •At screening, Creatine Kinase (CK) \> 3 × ULN ;
- •At screening, Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 × ULN or Total Bilirubin (TBIL), \> 1.5 × ULN （unless attributable to Gilbert's syndrome）;
- •At screening, prolonged QT/QTcF interval at Screening Period or prior to Randomization (QTcF \> 450 ms for males, \> 470 ms for females)
Arms & Interventions
SYH2053 injection
Experimental
Administer the medication in accordance with the requirements of the clinical trial protocol
Intervention: SYH2053 injection (Drug)
SYH2053 injection placebo
Placebo Comparator
Administer the medication in accordance with the requirements of the clinical trial protocol
Intervention: SYH2053 injection placebo (Other)
Outcomes
Primary Outcomes
Percentage change in LDL-C relative to baseline
Time Frame: Day 330
Secondary Outcomes
- Incidence and severity of adverse events (AE), serious adverse events (SAE), etc. Description:(Days 1-360)
- Number of ADA and Nab(Day 30-360)
- Time adjusted percent change in LDL-C levels from baseline between Day 90 and Day 360 levels(Day 90-360)
- The value of change in LDL-C relative to baseline(Day 330)
Investigators
Study Sites (3)
Loading locations...
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