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RECRUITING
NCT07421297
PHASE3

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

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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

760

Start Date

2026-02-28

Completion Date

2028-01-31

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

SYH2053 injection

Participants receive SYH2053 injection by subcutaneous administration.

OTHER

SYH2053 injection placebo

Participants receive SYH2053 injection placebo by subcutaneous administration.

Locations (2)

Affiliation: Peking University Third Hospital

Beijing, Beijing Municipality, China

Affiliation: Peking University Third Hospital

Beijing, Beijing Municipality, China