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

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Recruitment openedv3 Show 4 more changesShow less
    • Study sites: 1 to 2
    • Start date changed from estimate of Apr 1, 2026 to Feb 28, 2026
    • Interventions: SYH2053 injection placebo (Other), SYH2053injection (Drug) to SYH2053 injection (Drug), SYH2053 injection placebo (Other)
    • Eligibility criteria expanded, about 10 words
  2. Enrollment target: 900 to 760
    • Interventions: SYH2053/placebo injection (Drug) to SYH2053 injection placebo (Other), SYH2053injection (Drug)
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to evaluate the efficacy and safety of SYH2053 monotherapy in patients with primary hypercholesterolemia (non-familial) or mixed dyslipidemia . This trial plans to enroll 760 Participants.
Trial Details
NCT Number NCT07421297
Lead Sponsor CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Conditions
(from sponsor)		 Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
Related terms Hyperlipoproteinemia Type II
Enrollment 760 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov