A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholesterolemia or Mixed Hyperlipidemia

NCT07421297 | Not Yet Recruiting Phase 3

• 1 other identifier: SYH2053-005
• Study Type: interventional
• Target: 760
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-familial Hypercholesterolemia and Mixed Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Percentage change in LDL-C relative to baseline

  Day 330

Secondary Outcomes (4)

• 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

Study Arms (2)

SYH2053 injection

EXPERIMENTAL

Administer the medication in accordance with the requirements of the clinical trial protocol

Drug: SYH2053injection

SYH2053 injection placebo

PLACEBO COMPARATOR

Administer the medication in accordance with the requirements of the clinical trial protocol

Other: SYH2053 injection placebo

Interventions

SYH2053injection DRUG

Participants receive SYH2053 injection by subcutaneous administration.

SYH2053 injection

SYH2053 injection placebo OTHER

Participants receive SYH2053 injection placebo by subcutaneous administration.

SYH2053 injection placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 - 75 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）;
• ② Moderate to high risk: LDL-C ≥ 100 mg/dL (2.6 mmol/L);
• ③ LDL-C\<188 mg/dL（4.9 mmol/L）
• ④ Fasting serum Triglyceride (TG)\<500 mg/dL（5.6 mmol/L）
• Participants are able to establish good communication with the investigator and complete the trial in accordance with the protocol.

You may not qualify if:

• 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;
• 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;
• 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;
• HbA1c \> 8.0% at screening Period or prior to Randomization; or Type 1 diabetes , gestational diabetes ;
• History of drug abuse within 5 years, including the recurrent use of dependence-producing drugs or substances unrelated to medical purposes in large quantities, including addictive and habituating drugs that cause physical and psychological dependence;
• History of alcohol abuse within 1 year (defined as consuming more than 14 units of alcohol per week \[1 unit = 360 mL of beer with 5% alcohol content, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content\]);
• Participation in any other clinical trial involving the administration of an investigational drug within 3 months prior to Screening or within 5 half-lives of the other investigational drug (whichever is longer), or plans to participate in any other clinical trial during the study period;

Sponsors & Collaborators

• CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.: lead

Study Sites (1)

Affiliation: Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)