New drug YN001 aims to shrink artery plaque in heart disease trial

NCT ID NCT07521007

Disease control Sponsor: Beijing Inno Medicine Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 7 times

Summary

This study tests a drug called YN001 in 456 adults with coronary atherosclerosis (plaque buildup in heart arteries). Participants receive weekly injections of YN001 or a placebo for 13 weeks. The main goal is to see if YN001 reduces plaque volume in the arteries, as measured by a special CT scan. The trial is not yet recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: YN001 (a drug given by injection)
What this could lead to: If it works, this could point toward a new treatment to reduce artery plaque and better manage heart disease.
What could go wrong: This is an early Phase 2b trial, so it may not show clear benefit. The drug could have side effects, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 456 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atherosclerosis coronary artery disorder coronary atherosclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerosis Coronary artery disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

40 sites in 4 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Anhui Provincial Hospital
RECRUITING

Hefei, Anhui, 230001, China
Anzhen Hospital
RECRUITING

Beijing, Beijing Municipality, 100029, China
Beijing Jishuitan Hospital
RECRUITING

Beijing, Beijing Municipality, 100035, China
Beijing Luhe Hospital
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 101100, China
Cannopy Clinical Research
RECRUITING

Penrith, New South Wales, 2750, Australia
Canopy Clinical Research
RECRUITING

Altona N., Victoria, 3025, Australia
Capital Area Research
NOT_YET_RECRUITING

Camp Hill, Pennsylvania, 17011, United States
Central Hospital Affiliated to Shandong First Medicial University
RECRUITING

Jinan, Shandong, China
Clinical Trials Research
NOT_YET_RECRUITING

Lincoln, California, 95648, United States
Core Research Group Pty Ltd.
RECRUITING

Brisbane, Queensland, 4064, Australia
Excel Medical Clinical Trials dba Flourish Research - Boca Raton
NOT_YET_RECRUITING

Boca Raton, Florida, 33434, United States
Fudan University-Zhongshan Hospital
RECRUITING

Shanghai, Shanghai Municipality, 200032, China
Fujian Medical University Union Hospital
RECRUITING

Fuzhou, Fujian, 350001, China
Guangdong Provincial People's Hospital
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510080, China
HCA Florida Heart Institute
NOT_YET_RECRUITING

Petersburg, Florida, 33709, United States
Heart Center Research, LLC
NOT_YET_RECRUITING

Huntsville, Alabama, 35801, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
NOT_YET_RECRUITING

Torrance, California, 90502, United States
Midwest Heart & Vascular Specialists
NOT_YET_RECRUITING

Overland Park, Kansas, 66209, United States
North York Diagnostic and Cardiac Center
NOT_YET_RECRUITING

North York, Ontario, M6B 3H7, Canada
Renji Hospital Shanghai Jiaotong University school of medicine
RECRUITING

Shanghai, Shanghai Municipality, 200001, China
Shaanxi Provincial People's Hospital
RECRUITING

Xi'an, Shaanxi, 710068, China
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING

Chengdu, Sichuan, 610072, China
Southern Illinois University School of Medicine
NOT_YET_RECRUITING

Springfield, Illinois, 62781, United States
Stanford University School of Medicine
NOT_YET_RECRUITING

Stanford, California, 94305, United States
The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
NOT_YET_RECRUITING

Wenzhou, Zhejiang, 325000, China
The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
NOT_YET_RECRUITING

Cincinnati, Ohio, 45219, United States
The First Affiliated Hospital of Anhui Medical Unversity
RECRUITING

Hefei, An, 230022, China
The First Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING

Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Soochow University
NOT_YET_RECRUITING

Suzhou, Zhejiang, 215006, China
The First Hospital of Jilin University
RECRUITING

Changchun, Jilin, 130033, China
The People's Hospital of Liaoning Province
RECRUITING

Shenyang, Liaoning, 110015, China
The Second Hospital & Clinical Medical School Lanzhou University
RECRUITING

Lanzhou, Gansu, 730030, China
The Second Hospital of Tianjin Medical University
RECRUITING

Tianjin, Tianjin Municipality, 300211, China
The Second Xiangya Hospital fo Central South University
NOT_YET_RECRUITING

Changsha, Hunan, 410008, China
Tianjin People's Hospital
RECRUITING

Tianjin, Tianjin Municipality, 300121, China
Wake Forest University Health Sciences
NOT_YET_RECRUITING

Winston-Salem, North Carolina, 27157, United States
Washington University School of Medicine
RECRUITING

St Louis, Missouri, 63110, United States
West China Hospital of Sichuan University
RECRUITING

Chengdu, Sichuan, 610041, China
Zhengjiang Provincial People's Hospital
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310006, China
Zhongnan Hospital of Wuhan University
RECRUITING

Wuhan, Hubei, 430071, China

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