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Clinical Trials in Australia / NCT07521007
Recruiting Phase 2

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

NCT07521007 · tracked via the Priya Life Science Australia tracker
Sponsor
Beijing Inno Medicine Co., Ltd
Phase
Phase 2
Started
2026-07-31
Last updated
2026-09-22

Condition(s) studied

AtherosclerosisCoronary Artery Disease

Investigational drug(s) / intervention(s)

YN001/Placebo 40mgYN001/Placebo 20mgYN001/Placebo 0mg

YN001/Placebo 40mg: 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 20mg: YN001/Placebo 20mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.

YN001/Placebo 0mg: YN001/Placebo 0mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. Male or female participants between 18 and 80 years (inclusive, at the time of signing the ICF). 3. Participants must satisfy either of the following criteria: 1\) Have clinically evident atherosclerotic CV disease (ASCVD) 2) Meet at least two of the following criteria at screening/baseline, as evidenced by: 1. A history of Type 2 diabetes requiring treatment with medication, 2. Aged \> 55 years (women) or \> 50 years (men), 3. 2 or more of the following atherosclerosis risk factors: * Current cigarette smoker * Hypertension * Estimated glomerular filtration rate (eGFR) 45 to 60 ml/min/1.73m2 4\. 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. 5\. Female participants must be non-pregnant and non-lactating 6\. Willing and able to comply with the requirements of protocol to the best of the participant's and investigator's knowledge. Exclusion Criteria: 1. Prior treatment with other investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to randomization. 2. Previously received YN001. 3. Any type of vaccination within 4 weeks prior to randomization, or any planned vaccination during the study treatment period 4. Contraindication for CCTA 5. 3 major epicardial coronary arteries with ≥ 70% or left main ≥50% stenosis. 6. Acute MI that occurred within 4 weeks prior to randomization. 7. PCI performed within 2 weeks prior to randomization or PCI is required or planned during study treatment based on clinical indication for revascularization. 8. Clinically evident stroke or transient ischemic attack (TIA) within 6 months prior to randomization. 9. Relapse and highly symptomatic arrhythmia uncontrolled by drugs within the past 3 months. 10. 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. 11. New York Heart Association class III or IV or last known left ventricular ejection fraction (LVEF) was \<40%. 12. Carotid endarterectomy or stenting, peripheral arterial revascularization, or abdominal aortic aneurysm repair within 4 weeks prior to randomization. 13. History of myopathy or myositis, or susceptibility to myopathy/rhabdomyolysis (e.g., family history of hereditary myopathy, etc.). 14. History of severe myalgia attributed to statin therapy or other significant concern about statin side effects. 15. Known gastrointestinal ulcers, inflammatory bowel disease, or gastrointestinal/rectal bleeding within 6 months prior to randomization. 16. Evidence of unresolved major diseases 2 weeks prior to randomization or planned major surgery during the study that, in the investigator's judgement, may interfere with the investigational product administration or trial assessments. 17. Presenting with history of malignancy (except in participants who have been disease-free \>5 years; or whose only malignancy has been basal or squamous cell skin carcinoma). 18. Presence of any type of autoimmune disease. 19. Allergy to multiple foods or drugs or known sensitivity to any components to be administered during dosing. 20. Life expectancy is less than 1 year. 21. Systolic blood pressure of ≥ 160 mmHg at final screening despite antihypertensive therapy. 22. Triglycerides ≥ 400 mg/dL (4.5 mmol/L) at final screening. 23. LDL-C \> 100 mg/dL (2.6 mmol/L) at final screening. 24. Active liver disease or hepatic dysfunction defined by any of alanine aminotransaminase (ALT), aspartate aminotransferase (AST), \> 3 times upper limit of normal (ULN), or total bilirubin \> 2 times ULN at final screening. 25. Presence of renal dysfunction, defined by eGFR \< 45 ml/min/1.73m2. 26. Untreated or inadequately treated hypothyroidism. 27. Poorly controlled Type 2 diabetes mellitus. 28. A positive hepatitis B surface antigen (HBsAg), or positive antibody against hepatitis C virus (anti-HCV) or human immunodeficiency virus (anti-HIV), or positive treponema pallidum antibody (TP-Ab). 29. Presence of any other diseases or conditions (apart from those outlined above) that, in the opinion of the investigator, would make it unsuitable for the participant to participate in this study.

Primary outcome measure(s)

Trial sites (56)

FacilityCityRegionStatus
Heart Center Research, LLC Huntsville Alabama Not Yet Recruiting
Thrive Clinical Research Group, LLC Covina California Not Yet Recruiting
Clinical Trials Research Lincoln California Not Yet Recruiting
University of California Irvine Medical Center - Cardiovascular Center Los Alamitos California Not Yet Recruiting
Stanford Health Care General Cardiology Stanford California Not Yet Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California Not Yet Recruiting
Flourish Research - Boca Raton Boca Raton Florida Not Yet Recruiting
New Generation of Medical Research, LLC. Hialeah Florida Not Yet Recruiting
HCA Florida Heart Institute St. Petersburg Florida Not Yet Recruiting
Emory Healthcare-Emory Heart & Vascular Center - Executive Park Atlanta Georgia Not Yet Recruiting
St. Luke's Clinic - Idaho Cardiology Associates Meridian Idaho Not Yet Recruiting
Southern Illinois University School of Medicine Springfield Illinois Not Yet Recruiting
Midwest Heart & Vascular Specialists, LLC Overland Park Kansas Not Yet Recruiting
WU School of Medicine - (CAM) - Heart and Vascular Center St Louis Missouri Recruiting
NC Heart and Vascular Research, LLC Raleigh North Carolina Not Yet Recruiting
Javara Inc. - Wake Forest University Health Sciences Winston-Salem North Carolina Not Yet Recruiting
The Christ Hospital Cincinnati Ohio Not Yet Recruiting
South Oklahoma Heart Research, LLC Oklahoma City Oklahoma Not Yet Recruiting
Capital Area Research, LLC - Camp Hill Camp Hill Pennsylvania Not Yet Recruiting
PharmaTex Research, LLC Amarillo Texas Not Yet Recruiting
Pulse Care Heart and Vascular Carrollton Texas Not Yet Recruiting
DM Clinical Research - Dallas Tomball Texas Not Yet Recruiting
Cannopy Clinical Research Penrith New South Wales Recruiting
Core Research Group Pty Ltd. Brisbane Queensland Recruiting
Canopy Clinical Research Altona N. Victoria Recruiting
St. Boniface Hospital Winnipeg Manitoba Not Yet Recruiting
London Health Sciences Centre London Ontario Not Yet Recruiting
North York Diagnostic and Cardiac Centre North York Ontario Not Yet Recruiting
St. Michael's Hospital Toronto Ontario Not Yet Recruiting
Cardiac Clinic Vaughan Ontario Not Yet Recruiting
Toronto General Hospital - University Health Network Toronto Toronto Not Yet Recruiting
Anhui Provincial Hospital Hefei Anhui Recruiting
The First Affiliated Hospital of Anhui Medical Unversity Hefei An Recruiting
Anzhen Hospital Beijing Beijing Municipality Recruiting
Beijing Jishuitan Hospital Beijing Beijing Municipality Recruiting
Beijing Luhe Hospital Beijing Beijing Municipality Not Yet Recruiting
Fujian Medical University Union Hospital Fuzhou Fujian Recruiting
The Second Hospital & Clinical Medical School Lanzhou University Lanzhou Gansu Recruiting
Guangdong Provincial People's Hospital Guangzhou Guangdong Not Yet Recruiting
Daqing People's Hospital Daqing Heilongjiang Not Yet Recruiting

+ 16 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07521007 on ClinicalTrials.gov ↗ ← All trials in Australia