NCT07421232

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

A Phase Ⅱ Randomized, Parallel-group, Placebo-controlled, Active-controlled Trial to Assess the Efficacy, Safety of the SYH2053 Subcutaneous Injection in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Hypercholesterolemia and Mixed Hyperlipidemia

Interventions

Type	Name	Description
DRUG	SYH2053/placebo injection	Participants receive SYH2053/placebo injection by subcutaneous administration.
DRUG	Inclisiran (Leqvio®) 300mg	Participants receive Leqvio® injection by subcutaneous administration.

Timeline

• Start date: 2024-12-03
• Primary completion: 2025-08-30
• Completion: 2026-02-12
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: China