Recruiting
Phase 2

YN001

Sponsor:

Beijing Inno Medicine Co., Ltd.

Code:

NCT07521007

Conditions

Atherosclerosis

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

YN001/Placebo 40mg

YN001/Placebo 20mg

YN001/Placebo 0mg

Study Details

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

Study ID

NCT07521007

Start date

Jul 31, 2026

Status verified date

Aug, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

456 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose 1 YN001/Placebo 40mg

Dose 1 YN001/Placobo 40mg will be administrated intravenously weekly

experimental: Dose 2 YN001/Placebo 20mg

Dose 2 YN001/Placebo 20mg will be administrated intravenously weekly

placebo comparator: Dose 3 YN001/Placebo 0mg

Dose 3 YN001/Placebo 0mg will be administrated intravenously weekly

Interventions

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.

Primary outcome measure

  • Relative change from baseline in coronary NCPV at Week 13 [ Time Frame: Baseline to Week 13 ]

Central Contacts and Locations

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

More Information

Sponsor

Beijing Inno Medicine Co., Ltd.

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • Plaque regression
  • Plaque stabilization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Beijing Inno Medicine Co., Ltd. on 2026-08-21.