NCT07421297

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 760 (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 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.

Conditions

• Non-familial Hypercholesterolemia and Mixed Hyperlipidemia

Interventions

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

Timeline

• Start date: 2026-02-28
• Primary completion: 2027-12-31
• Completion: 2028-01-31
• First posted: 2026-02-19
• Last updated: 2026-04-07

Locations

2 sites across 1 country: China