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

RecruitingPhase 3

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

Conditions: Heterozygous Familial Hypercholesterolemia (HeFH)

Interventions: SYH2053 Injection, Placebo Injection

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

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Locations (1)

Beijing, Beijing Municipality, China