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Studies

Interventional Recruiting Phase 2

NCT07521007 on ClinicalTrials.gov

A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis

Official title: A Randomized, Multicenter, Double-Blind, Parallel, Placebo-controlled Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of YN001 in Adults With Coronary Atherosclerosis

  • Sponsor: Beijing Inno Medicine Co., Ltd.
  • Collaborators: The TIMI Study Group
  • Enrollment: 456 (Estimated)
  • Study start: 2026-07-31 (Actual)
  • Primary completion: 2027-07-31 (Estimated)
  • Study completion: 2029-03-31 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: A double-blind treatment period of 12 weeks
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

This study is designed to evaluate the efficacy and safety of intravenously administered YN001 in patients diagnosed with coronary atherosclerosis, who are receiving background therapy for cardiovascular (CV) risk factors management.

Conditions

  • Atherosclerosis
  • Coronary Artery Disease

Intervention / Treatment

  • Drug: YN001/Placebo 40mg
  • Drug: YN001/Placebo 20mg
  • Drug: YN001/Placebo 0mg

Primary Outcome Measures

  • Relative change from baseline in coronary NCPV at Week 13 (Baseline to Week 13)
    Relative change in coronary NCPV from baseline to Week 13 as determined by coronary computed tomography angiography (CCTA)

Countries

Australia, Canada, China, United States

Locations and Investigators

  • Heart Center Research, LLC, Huntsville, United States (Not yet recruiting)
    • Walter Haught, MD
  • Thrive Clinical Research Group, LLC, Covina, United States (Not yet recruiting)
    • Sami Hayek
  • Clinical Trials Research, Lincoln, United States (Not yet recruiting)
    • Jeffrey Wayne, MD
  • University of California Irvine Medical Center - Cardiovascular Center, Los Alamitos, United States (Not yet recruiting)
    • Arnold Seto
  • Stanford Health Care General Cardiology, Stanford, United States (Not yet recruiting)
    • Fahim Abbasi, MD
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, United States (Recruiting)
    • Matthew Budoff, MD
  • Flourish Research - Boca Raton, Boca Raton, United States (Not yet recruiting)
    • Richard Goldman
  • New Generation of Medical Research, LLC., Hialeah, United States (Not yet recruiting)
    • Karelia Ruiz
  • HCA Florida Heart Institute, St. Petersburg, United States (Recruiting)
    • Robert Sanchez, MD
  • Emory Healthcare-Emory Heart & Vascular Center - Executive Park, Atlanta, United States (Not yet recruiting)
    • Modele Ogunniyi
  • St. Luke's Clinic - Idaho Cardiology Associates, Meridian, United States (Not yet recruiting)
    • Brian Nolan
  • Southern Illinois University School of Medicine, Springfield, United States (Not yet recruiting)
    • Abdul Hafiz, MD
  • Midwest Heart & Vascular Specialists, LLC, Overland Park, United States (Recruiting)
    • Stephen Bloom, MD
  • WU School of Medicine - (CAM) - Heart and Vascular Center, St Louis, United States (Recruiting)
    • Farhan Katchi, MD
  • NC Heart and Vascular Research, LLC, Raleigh, United States (Not yet recruiting)
    • Mohit Pasi
  • Javara Inc. - Wake Forest University Health Sciences, Winston-Salem, United States (Not yet recruiting)
    • Michael Shapiro, MD
  • The Christ Hospital, Cincinnati, United States (Not yet recruiting)
    • Mark Berlacher, MD
  • South Oklahoma Heart Research, LLC, Oklahoma City, United States (Not yet recruiting)
    • Naeem Tahirkheli
  • Capital Area Research, LLC - Camp Hill, Camp Hill, United States (Recruiting)
    • Venkatesh Nadar, MD
  • PharmaTex Research, LLC, Amarillo, United States (Not yet recruiting)
    • David Brabham
  • Pulse Care Heart and Vascular, Carrollton, United States (Not yet recruiting)
    • Kiran Kumar Mangalpally
  • DM Clinical Research - Dallas, Tomball, United States (Not yet recruiting)
    • Mustafa Mandviwala
  • Cannopy Clinical Research, Penrith, Australia (Recruiting)
    • Karen Kaluhin, MD
  • Core Research Group Pty Ltd., Brisbane, Australia (Recruiting)
    • David Colquhou, MD
  • Canopy Clinical Research, Altona N., Australia (Recruiting)
    • Oscar Walsh, MD
  • St. Boniface Hospital, Winnipeg, Canada (Not yet recruiting)
    • Shuangbo Liu
  • London Health Sciences Centre, London, Canada (Not yet recruiting)
    • Habib Khan
  • North York Diagnostic and Cardiac Centre, North York, Canada (Not yet recruiting)
    • Subodh Verma, MD
  • St. Michael's Hospital, Toronto, Canada (Not yet recruiting)
    • John Graham
  • Cardiac Clinic, Vaughan, Canada (Not yet recruiting)
    • Navneet Singh
  • Toronto General Hospital - University Health Network, Toronto, Canada (Not yet recruiting)
    • Jacob Udell
  • Anhui Provincial Hospital, Hefei, China (Recruiting)
    • Kangyu Chen, MD
    • Kangyu Chen, MD (Principal Investigator)
    • Chao Gao, MD
  • The First Affiliated Hospital of Anhui Medical Unversity, Hefei, China (Recruiting)
    • Jianlong Wang, MD
  • Anzhen Hospital, Beijing, China (Recruiting)
    • Yuyang Liu, MD
    • Yuyang Liu, MD (Principal Investigator)
  • Beijing Jishuitan Hospital, Beijing, China (Recruiting)
    • Qingwei Ji, MD
    • Qingwei Ji, MD (Principal Investigator)
    • Wei Liu, MD (Principal Investigator)
  • Beijing Luhe Hospital, Beijing, China (Not yet recruiting)
    • Guangyao Zhai, MD
  • Fujian Medical University Union Hospital, Fuzhou, China (Recruiting)
    • Mingfang Ye, MD
    • Mingfang Ye, MD (Principal Investigator)
    • Zhaoyang Chen, MD
  • The Second Hospital & Clinical Medical School Lanzhou University, Lanzhou, China (Recruiting)
    • Feng Bai, MD
  • Guangdong Provincial People's Hospital, Guangzhou, China (Not yet recruiting)
    • Ning Tan, MD
  • Daqing People's Hospital, Daqing, China (Not yet recruiting)
    • Shu Zhang
  • The First Affiliated Hospital of Harbin Medical University, Harbin, China (Recruiting)
    • Lu Fu, MD
    • Lu Fu, MD (Principal Investigator)
    • Yongtai Gong, MD (Principal Investigator)
  • Zhongnan Hospital of Wuhan University, Wuhan, China (Recruiting)
    • Xiaorong Hu, MD
    • Xiaorong Hu, MD (Principal Investigator)
  • The Second Xiangya Hospital fo Central South University, Changsha, China (Not yet recruiting)
    • Xinqun Hu, MD
  • The First Hospital of Jilin University, Changchun, China (Recruiting)
    • Qian Tong, MD
    • Qian Tong, MD (Principal Investigator)
  • The People's Hospital of Liaoning Province, Shenyang, China (Recruiting)
    • Ying Liu, MD
    • Ying Liu, MD (Principal Investigator)
  • Shaanxi Provincial People's Hospital, Xi'an, China (Recruiting)
    • Xiling Shou, MD
  • Central Hospital Affiliated to Shandong First Medicial University, Jinan, China (Recruiting)
    • Guohai Su, MD
  • Renji Hospital Shanghai Jiaotong University school of medicine, Shanghai, China (Recruiting)
    • Jun Bu, MD
    • Jun Bu, MD (Principal Investigator)
  • Fudan University-Zhongshan Hospital, Shanghai, China (Recruiting)
    • Junbo Ge, MD
    • Junbo Ge, MD (Principal Investigator)
    • Yuxiang Dai, MD
  • West China Hospital of Sichuan University, Chengdu, China (Recruiting)
    • Yong He, MD
    • Yong He, MD (Principal Investigator)

And 6 other sites.

Study Officials

  • Ying Chen, PhD (Study Director) — Beijing Inno Medicine Co., Ltd.