NCT07421284

A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia on a Background of Lipid-lowering Therapy

A Phase Ⅲ Randomized, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety of the SYH2053 Subcutaneous Injection in Participants With Primary Hypercholesterolemia (Non-familial) or Mixed Dyslipidemia on a Background of Lipid-lowering Therapy

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effectiveness, safety of SYH2053 in participants with primary hypercholesterolemia (non-familial) or mixed dyslipidemia on a background of lipid-lowering therapy. This trial plans to enroll 900 Participants.

Conditions

• Non-familial Hypercholesterolemia and Mixed Hyperlipidemia

Interventions

Type	Name	Description
DRUG	SYH2053/placebo injection	Participants receive SYH2053/placebo injection by subcutaneous administration.

Timeline

• Start date: 2026-03-31
• Primary completion: 2027-12-31
• Completion: 2028-01-31
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: China