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RECRUITING

NCT07465263

PHASE3

A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)

Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

View on ClinicalTrials.gov

Summary

Heterozygous Familial Hypercholesterolemia (HeFH) is an autosomal dominant disorder characterized by markedly elevated low-density lipoprotein cholesterol (LDL-C) and increased risk of atherosclerotic cardiovascular disease (ASCVD). This trial aims to evaluate the SYH2053 Injection in patients with HeFH.

Official title: A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2026-03-31

Completion Date

2028-05-31

Last Updated

2026-07-08

Healthy Volunteers

Yes

Conditions

Heterozygous Familial Hypercholesterolemia (HeFH)

Interventions

DRUG

SYH2053 Injection

Administered by subcutaneous injection.

DRUG

Placebo Injection

Administered by subcutaneous injection. The placebo is identical to SYH2053 Injection in appearance.

Inclusion Criteria: 1. Male or female participants ≥18 years of age. 2. HeFH. 3. Stable moderate-to-high intensity statin therapy (± cholesterol absorption inhibitors) . 4. Maintained a low-fat diet for ≥4 weeks before signing the ICF. 5. Fasting LDL-C at screening ≥ 2.6 mmol/L or ≥ 1.4 mmol/L without ASCVD or with ASCVD. 6. Fasting TG ≤5.6 mmol/L at screening. Exclusion Criteria: 1. HoFH or suspected HoFH. 2. Use of medications that significantly affect LDL-C levels. 3. Hypersensitivity or suspected allergy to oligonucleotide drugs or excipients of the investigational product. 4. Major adverse cardiovascular events (MACE) within 180 days before signing the ICF; history of hemorrhagic stroke; or extreme-risk ASCVD at screening. 5. Uncontrolled (by medication/ablation) or severe arrhythmias within 180 days before signing the ICF. 6. NYHA Class III-IV heart failure or LVEF \<40% within 1 year before signing ICF or at screening. 7. Type 1 diabetes. 8. Uncontrolled severe illness or conditions that may interfere with study results/increase risk at screening, according to investigator's judgment. 9. History of malignancy or underlying malignancy within 5 years before signing ICF or at screening. 10. Major surgery within 180 days before signing ICF or planned during the study. 11. History of drug/alcohol abuse within 5 years before signing ICF. 12. Participation in another clinical trial within 90 days or 5 half-lives (whichever is longer) before signing ICF, or planned during the study. 13. Any of the following at screening: 1）SBP ≥160 mmHg or DBP ≥100 mmHg. 2）ALT/AST \>3× ULN, or total bilirubin \>1.5× ULN. 3）CK \>2.5× ULN. 4）QTcF interval: \>450 ms for male, \>470 ms for female. 5）eGFR \<30 mL/min/1.73 m². 6）HBsAg positive with HBV DNA positive; or HCV/syphilis/HIV antibody positive. 7）TSH\<LLN, or TSH\>ULN. 8）HbA1c \>8.5%. 14.Pregnancy/lactation or planned parenthood, and/or without effective contraception for female and male participants of childbearing potential from the study to 3 months after the end of treatment. \-

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China