Phase II Clinical Trial to Evaluate the Efficacy and Safety of SYH2070 Injection in Participants With Homozygous Familial Hypercholesterolemia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • SYH2070 injection dose1

    Drug

    The patient will receive a treatment period of 48weeks

  • SYH2070 injection dose2

    Drug

    The patient will receive a treatment period of 48weeks

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: SYH2070 injection dose1Experimental treatment 1 intervention
Group B: SYH2070 injection dose2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The percentage change in serum LDL-C level from baseline

Time frame
week 24

Secondary outcomes

Other outcomes

Sponsors and contacts

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