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NOT YET RECRUITING
NCT07551492
PHASE3

A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease

Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the impact of HRS9531 on major adverse cardiovascular events (MACE) in patients with atherosclerotic cardiovascular disease. This study adopts an event-driven design and ends when the target number of the primary endpoint event is reached.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Participants With Atherosclerotic Cardiovascular Disease (ASCVD)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

9262

Start Date

2026-05

Completion Date

2031-06

Last Updated

2026-04-24

Healthy Volunteers

No

Interventions

DRUG

HRS9531

HRS9531 Dose 1 , subcutaneous injection

DRUG

HRS9531 placebo

HRS9531 placebo Dose 1, subcutaneous injection

Locations (1)

Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, China