The purpose of this study is to evaluate the efficacy and safety of SYH2068 injection in patients with elevated lipoprotein(a).
This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase II clinical trial aimed at evaluating the efficacy, safety, immunogenicity, and pharmacokinetic characteristics of SYH2068 injection in adult participants with elevated lipoprotein(a). The study consists of a screening period and a treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Administered by subcutaneous injection.
Administered by subcutaneous injection.
Administered by subcutaneous injection.
Percentage change in Lp(a) from baseline to Day 60~180
Time frame: Day 60~180
Percentage change in Lp(a) from baseline to Day 30~540
Time frame: Day 30~540
The percentage of participants achieving Lp(a) < 125 nmol/L and <75 nmol/L.
Time frame: Day 30~540
Changes of LDL-C from baseline to Day 30~540
Time frame: Day 30~540
Changes of ApoB from baseline to Day 30~540
Time frame: Day 30~540
Incidence of TEAEs during the treatment
Time frame: During treatment
ADA incidence
Time frame: During treatment
The plasma concentration of SYH2068.
Time frame: During treatment
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Administered by subcutaneous injection.