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

Recruiting Phase 3 Interventional Study
Atherosclerotic Cardiovascular Disease
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
9,262 (estimated)
Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Diagnosed with atherosclerotic cardiovascular disease (ASCVD), and the course of the disease exceeds 3 months 2. The body mass index (BMI) at the time of screening was ≥24.0 kg/m ². Patients with type 2 diabetes have a BMI of ≥22.0 kg/m ² Exclusion Criteria: 1. Screening fo…
Contacts

Sheng Qi

+8613482562074

Sheng.qi@hengrui.com

CONTACT