A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis
PURIFY-TIMI 81
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
2 other identifiers
interventional
456
4 countries
56
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2026
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2026
CompletedFirst Posted
Study publicly available on registry
April 9, 2026
CompletedStudy Start
First participant enrolled
July 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
September 22, 2026
September 1, 2026
1 year
April 2, 2026
September 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relative change from baseline in coronary NCPV at Week 13
Relative change in coronary NCPV from baseline to Week 13 as determined by coronary computed tomography angiography (CCTA)
Baseline to Week 13
Secondary Outcomes (13)
Absolute change from baseline in carotid intima-media thickness (IMT) at Week 13
From baseline to Week 13
Absolute change from baseline in carotid intima-media thickness (IMT) at Week 9
From baseline to Week 9
Relative change from baseline in carotid intima-media thickness (IMT) at Week 13
From baseline to Week 13
Relative change in the maximum thickness and area of carotid plaque at Week 9, and Week 13
From baseline to Week 9 and Week 13
Relative change in coronary Percent Atheroma Volume (PAV) at Week 13
From baseline to Week 13
- +8 more secondary outcomes
Study Arms (3)
Dose 1 YN001/Placebo 40mg
EXPERIMENTALDose 1 YN001/Placobo 40mg will be administrated intravenously weekly
Dose 2 YN001/Placebo 20mg
EXPERIMENTALDose 2 YN001/Placebo 20mg will be administrated intravenously weekly
Dose 3 YN001/Placebo 0mg
PLACEBO COMPARATORDose 3 YN001/Placebo 0mg will be administrated intravenously weekly
Interventions
YN001/Placebo 20mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.
Dose 1 YN001/Placebo 40mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.
YN001/Placebo 0mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.
Eligibility Criteria
You may qualify if:
- Fully understands the purposes, features, and methods of the study and the possible adverse reactions, and is voluntarily willing to participate in the study, and signs the informed consent form (ICF) before performing any study-specific assessment.
- Male or female participants between 18 and 80 years (inclusive, at the time of signing the ICF).
- Participants must satisfy either of the following criteria:
- \) Have clinically evident atherosclerotic CV disease (ASCVD) 2) Meet at least two of the following criteria at screening/baseline, as evidenced by:
- A history of Type 2 diabetes requiring treatment with medication,
- Aged \> 55 years (women) or \> 50 years (men),
- or more of the following atherosclerosis risk factors:
- Current cigarette smoker
- Hypertension
- Estimated glomerular filtration rate (eGFR) 45 to 60 ml/min/1.73m2
- \. Known coronary atherosclerosis as evidenced through coronary angiography or CCTA. The following criteria must be met on the core lab CCTA interpretation for the patient to be enrolled: at least one epicardial coronary artery with a lumen stenosis of 25% to 69%, total coronary NCPV is at least 75 mm3, Detectable low-attenuation composition in one or more individual plaques.
- \. Female participants must be non-pregnant and non-lactating
- \. Willing and able to comply with the requirements of protocol to the best of the participant's and investigator's knowledge.
You may not qualify if:
- Prior treatment with other investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to randomization.
- Previously received YN001.
- Any type of vaccination within 4 weeks prior to randomization, or any planned vaccination during the study treatment period
- Contraindication for CCTA
- major epicardial coronary arteries with ≥ 70% or left main ≥50% stenosis.
- Acute MI that occurred within 4 weeks prior to randomization.
- PCI performed within 2 weeks prior to randomization or PCI is required or planned during study treatment based on clinical indication for revascularization.
- Clinically evident stroke or transient ischemic attack (TIA) within 6 months prior to randomization.
- Relapse and highly symptomatic arrhythmia uncontrolled by drugs within the past 3 months.
- Prior coronary artery bypass graft (CABG), aortic root surgery with coronary reimplantation, left ventricular assist device (LVAD) placement, surgical aortic valve replacement (SAVR), transcatheter aortic valve replacement (TAVR), or heart transplantation, or a plan to undergo these procedures (CABG, aortic root surgery with coronary reimplantation, LVAD placement, SAVR, TAVR, or heart transplantation) during the study.
- New York Heart Association class III or IV or last known left ventricular ejection fraction (LVEF) was \<40%.
- Carotid endarterectomy or stenting, peripheral arterial revascularization, or abdominal aortic aneurysm repair within 4 weeks prior to randomization.
- History of myopathy or myositis, or susceptibility to myopathy/rhabdomyolysis (e.g., family history of hereditary myopathy, etc.).
- History of severe myalgia attributed to statin therapy or other significant concern about statin side effects.
- Known gastrointestinal ulcers, inflammatory bowel disease, or gastrointestinal/rectal bleeding within 6 months prior to randomization.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Inno Medicine Co., Ltd.lead
- The TIMI Study Groupcollaborator
Study Sites (56)
Heart Center Research, LLC
Huntsville, Alabama, 35801-4312, United States
Thrive Clinical Research Group, LLC
Covina, California, 91740, United States
Clinical Trials Research
Lincoln, California, 95648, United States
University of California Irvine Medical Center - Cardiovascular Center
Los Alamitos, California, 90720, United States
Stanford Health Care General Cardiology
Stanford, California, 94305-2200, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502-2006, United States
Flourish Research - Boca Raton
Boca Raton, Florida, 33434, United States
New Generation of Medical Research, LLC.
Hialeah, Florida, 33016-1895, United States
HCA Florida Heart Institute
St. Petersburg, Florida, 33709, United States
Emory Healthcare-Emory Heart & Vascular Center - Executive Park
Atlanta, Georgia, 30303-3049, United States
St. Luke's Clinic - Idaho Cardiology Associates
Meridian, Idaho, 83642, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62781, United States
Midwest Heart & Vascular Specialists, LLC
Overland Park, Kansas, 66211-1215, United States
WU School of Medicine - (CAM) - Heart and Vascular Center
St Louis, Missouri, 63110-1032, United States
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, 27607, United States
Javara Inc. - Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27104-3520, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, 73135, United States
Capital Area Research, LLC - Camp Hill
Camp Hill, Pennsylvania, 17011, United States
PharmaTex Research, LLC
Amarillo, Texas, 79106, United States
Pulse Care Heart and Vascular
Carrollton, Texas, 75010, United States
DM Clinical Research - Dallas
Tomball, Texas, 77375, United States
Cannopy Clinical Research
Penrith, New South Wales, 2750, Australia
Core Research Group Pty Ltd.
Brisbane, Queensland, 4064, Australia
Canopy Clinical Research
Altona N., Victoria, 3025, Australia
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
London Health Sciences Centre
London, Ontario, N5A 5A5, Canada
North York Diagnostic and Cardiac Centre
North York, Ontario, M6B 3H7, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Cardiac Clinic
Vaughan, Ontario, L6A 4N9, Canada
Toronto General Hospital - University Health Network
Toronto, Toronto, M5G 2N2, Canada
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
The First Affiliated Hospital of Anhui Medical Unversity
Hefei, An, 230022, China
Anzhen Hospital
Beijing, Beijing Municipality, 100029, China
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035, China
Beijing Luhe Hospital
Beijing, Beijing Municipality, 101100, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
The Second Hospital & Clinical Medical School Lanzhou University
Lanzhou, Gansu, 730030, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Daqing People's Hospital
Daqing, Heilongjiang, 163316, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
The Second Xiangya Hospital fo Central South University
Changsha, Hunan, 410008, China
The First Hospital of Jilin University
Changchun, Jilin, 130033, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, 110015, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068, China
Central Hospital Affiliated to Shandong First Medicial University
Jinan, Shandong, China
Renji Hospital Shanghai Jiaotong University school of medicine
Shanghai, Shanghai Municipality, 200001, China
Fudan University-Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310006, China
The First Affiliated Hospital of Soochow University
Suzhou, Zhejiang, 215006, China
The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ying Chen, PhD
Beijing Inno Medicine Co., Ltd.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind (Investigator and participants)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2026
First Posted
April 9, 2026
Study Start
July 31, 2026
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
March 31, 2029
Last Updated
September 22, 2026
Record last verified: 2026-09