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NOT YET RECRUITING
NCT07421284
PHASE3

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

Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

900

Start Date

2026-03-31

Completion Date

2028-01-31

Last Updated

2026-02-19

Healthy Volunteers

No

Interventions

DRUG

SYH2053/placebo injection

Participants receive SYH2053/placebo injection by subcutaneous administration.

Locations (1)

Affiliation: Peking University Third Hospital

Beijing, Beijing Municipality, China