NCT07465263RecruitingPhase 3
A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)
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
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 135 (estimated)
- First submitted
- 6 Mar 2026
- Start date
- 31 Mar 2026
- Primary completion date
- 28 Feb 2028
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07465263
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 135
- From 31 Mar 2026 to the primary completion date, 28 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of medications that significantly affect LDL-C levels.
- Hypersensitivity or suspected allergy to oligonucleotide drugs or excipients of the investigational product.
- Major adverse cardiovascular events (MACE) within 180 days before signing the ICF; history of hemorrhagic stroke; or extreme-risk ASCVD at screening.
- Uncontrolled (by medication/ablation) or severe arrhythmias within 180 days before signing the ICF.
- Major surgery within 180 days before signing ICF or planned during the study.
Other illness
- Type 1 diabetes.
- Uncontrolled severe illness or conditions that may interfere with study results/increase risk at screening, according to investigator's judgment.
- History of malignancy or underlying malignancy within 5 years before signing ICF or at screening.
- History of drug/alcohol abuse within 5 years before signing ICF.
Lab values
- NYHA Class III-IV heart failure or LVEF \<40% within 1 year before signing ICF or at screening.
- 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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Other
- HoFH or suspected HoFH.
- Participation in another clinical trial within 90 days or 5 half-lives (whichever is longer) before signing ICF, or planned during the study.
Who the study is looking for
- Male or female participants ≥18 years of age.
- HeFH.
- Stable moderate-to-high intensity statin therapy (± cholesterol absorption inhibitors) .
- Maintained a low-fat diet for ≥4 weeks before signing the ICF.
- Fasting LDL-C at screening ≥ 2.6 mmol/L or ≥ 1.4 mmol/L without ASCVD or with ASCVD.
- Fasting TG ≤5.6 mmol/L at screening.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.