About this trial
This trial is a multicenter, open-label, phase II clinical study, aiming to evaluate the efficacy and safety of SYH2070 injection in participants with HoFH.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old, male or female, and weight ≥40 kg.
Genetic diagnosis or clinical diagnosis of HoFH.
Receiving stable and tolerable lipid-lowering treatment or other drugs for chronic disease treatment for certain periods before the study, and maintaining the stable -treatments throughout the study.
Fasting serum LDL-C ≥2.6 mmol/L.
Disqualifiers
The genetic diagnosis was for heterozygous familial hypercholesterolemia;
During the screening process, the participant has uncontrolled other diseases that affect blood lipids or lipoproteins (such as nephrotic syndrome, severe liver diseases, glycogen storage disease, systemic lupus erythematosus, Cushing's syndrome, etc.) that the researchers believed would interfere with the accurate assessment of the study validity;
The participant has received or is receiving monoclonal antibodies targeting ANGPTL3 within 5 months or 5 half-lives (whichever is longer) before the LDL-C test during the screening period;
Within 12 months before the LDL-C test during the screening period, use of any ASO or siRNA type drugs;
Trial design
Parallel
Treatments tested in this trial
SYH2070 injection dose1
DrugThe patient will receive a treatment period of 48weeks
SYH2070 injection dose2
DrugThe patient will receive a treatment period of 48weeks
Treatment groups
Trial outcomes
Primary outcomes
The percentage change in serum LDL-C level from baseline
Sponsors and contacts
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