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New treatment option for Heterozygous Familial Hypercholesterolemia (HeFH)
Official title A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)
ClinicalTrials.gov ID: NCT07465263
What this study is testing
What is SYH2053 Injection?
SYH2053 Injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for heterozygous familial hypercholesterolemia (hefh).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- HoFH or suspected HoFH.
- 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.
- NYHA Class III-IV heart failure or LVEF \<40% within 1 year before signing ICF or at screening.
See the full eligibility criteria
- 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.
- HoFH or suspected HoFH.
- 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.
- NYHA Class III-IV heart failure or LVEF \<40% within 1 year before signing ICF or at screening.
- 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.
- Major surgery within 180 days before signing ICF or planned during the study.
- History of drug/alcohol abuse within 5 years before signing ICF.
- Participation in another clinical trial within 90 days or 5 half-lives (whichever is longer) before signing ICF, or planned during the study.
- 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 \ ULN. 8）HbA1c...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.