NCT07421284
Not yet recruiting
Phase 3
A Phase Ⅲ Randomized, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety of the SYH2053 Subcutaneous Injection in Participants With Primary Hypercholesterolemia (Non-familial) or Mixed Dyslipidemia on a Background of Lipid-lowering Therapy
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.1 site in 1 country900 target enrollmentStarted: March 31, 2026Last updated:
InterventionsSYH2053/placebo injection
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 900
- Locations
- 1
- Primary Endpoint
- Percentage change in LDL-C relative to baseline
Overview
Brief Summary
The purpose of this study is to compare the effectiveness, safety of SYH2053 in participants with primary hypercholesterolemia (non-familial) or mixed dyslipidemia on a background of lipid-lowering therapy.
This trial plans to enroll 900 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 of 18 - 75 years (inclusive);
- •Participants with primary hypercholesterolemia or mixed dyslipidemia who have maintained stable dose of lipid-lowering therapy (statin with other lipid-lowering therapy) ≥4 weeks;
- •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):
- •With a history of ASCVD:
- •Very high risk: 55 mg/dL (1.4 mmol/L) ≤ LDL-C \< 188 mg/dL (4.9 mmol/L);
- •Extremely high risk: LDL-C ≥ 70 mg/dL (1.8 mmol/L);
- •Without a history of ASCVD:
- •Moderate to high risk: LDL-C ≥ 100 mg/dL (2.6 mmol/L);
- •Low risk: LDL-C ≥ 130 mg/dL (3.4 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；
- •Treatment with PCSK9 monoclonal antibodies or oral PCSK9 inhibitors within the past 180 days before screening or treatment with incisiran or any other RNA-based lipid-lowering therapy 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;
- •Systolic blood pressure (SBP) \> 180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg during the Screening Period or prior to Randomization;
- •History of heart failure with NYHA Class III-IV within 180days before screening or prior to Randomization, or LVEF \< 40% within 180 days before screening;
- •eGFR \< 30 mL/min/1.73 m² during the Screening Period or prior to Randomization;
- •Creatine Kinase (CK) \> 3 × ULN at Screening Period;
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 × ULN or Total Bilirubin (TBIL), \> 1.5 × ULN at Screening Period or prior to Randomization;
- •Prolonged QT/QTcF interval at Screening Period or prior to Randomization (QTcF \> 450 ms for males, \> 470 ms for females)
- •Positive result for any one of hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, syphilis antibody, or Human Immunodeficiency Virus (HIV) antibody;
Arms & Interventions
SYH2053 injection
Experimental
Participants in this cohort receive three doses
Intervention: SYH2053/placebo injection (Drug)
SYH2053 injection placebo
Placebo Comparator
Participants in this cohort receive three doses
Intervention: SYH2053/placebo injection (Drug)
Outcomes
Primary Outcomes
Percentage change in LDL-C relative to baseline
Time Frame: Day 330
Secondary Outcomes
- The value of change in LDL-C relative to baseline(Day 330)
- Time adjusted percent change in LDL-C levels from baseline between Day 90 and Day 360 levels(Day 90-360)
- Incidence and severity of adverse events (AE), serious adverse events (SAE), etc. Description:(Days 1-360)
- Number of ADA and Nab(Day 30-360)
Investigators
Study Sites (1)
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