A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia

Sponsor
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Study ID
NCT07421232
Phase
PHASE2
Status
Completed

Conditions

  • Hypercholesterolemia and Mixed Hyperlipidemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SYH2053/placebo injection — DRUG
    Participants receive SYH2053/placebo injection by subcutaneous administration.
  • Inclisiran (Leqvio®) 300mg — DRUG
    Participants receive Leqvio® injection by subcutaneous administration.

Study Details

The purpose of this study is to compare the effectiveness, safety of SYH2053 in Participants with primary hypercholesterolemia or mixed dyslipidemia. A total of 156 Participants were actually enrolled

Key Dates

Start date
Dec 3, 2024
Status verified
Feb 2026
Primary completion
Aug 30, 2025
Completion
Feb 12, 2026

Study Design

Enrollment
156 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low-dose SYH2053 injection
    Participants in this cohort receive two doses
  • Experimental: Medium-dose SYH2053 injection
    Participants in this cohort receive two doses
  • Experimental: High-dose SYH2053 injection
    Participants in this cohort receive two doses
  • Placebo Comparator: SYH2053 injection placebo
    Participants in this cohort receive two doses
  • Active Comparator: Inclisiran (Leqvio®) 300mg
    Participants in this cohort receive two doses

Primary Outcome Measure

Percentage change in LDL-C relative to baseline [ Time Frame: Day 180 ]