NCT07521007

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

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
456

participants targeted

Target at P75+ for phase_2

Timeline
34mo left

Started Apr 2026

Typical duration for phase_2

Geographic Reach
1 country

13 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Mar 2029

First Submitted

Initial submission to the registry

April 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

April 2, 2026

Last Update Submit

April 2, 2026

Conditions

Coronary Artery DiseaseAtherosclerosis

Keywords

Plaque regressionPlaque stabilization

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

EXPERIMENTAL

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

Drug: YN001/Placebo 40mg

Dose 2 YN001/Placebo 20mg

EXPERIMENTAL

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

Drug: YN001/Placebo 20mg

Dose 3 YN001/Placebo 0mg

PLACEBO COMPARATOR

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

Drug: YN001/Placebo 0mg

Interventions

YN001/Placebo 40mgDRUG

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

Dose 1 YN001/Placebo 40mg
YN001/Placebo 20mgDRUG

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

Dose 2 YN001/Placebo 20mg
YN001/Placebo 0mgDRUG

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

Dose 3 YN001/Placebo 0mg

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (13)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130033, China

Location

The People's Hospital of Liaoning Province

Shenyang, Liaoning, 110015, China

Location

Renji Hospital Shanghai Jiaotong University school of medicine

Shanghai, Shanghai Municipality, 200001, China

Location

Fudan University-Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300121, China

Location

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

Location

MeSH Terms

Conditions

AtherosclerosisCoronary Artery Disease

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart Diseases

Study Officials

  • Ying Chen, PhD

    Beijing Inno Medicine Co., Ltd.

    STUDY DIRECTOR

Central Study Contacts

Jingmei Zhang, Master

CONTACT

0086 010 82599080zhangjingmei@innovmedicine.com

Kaiqi Zong, Master

CONTACT

0086 010 82599080zongkaiqi@innovmedicine.com

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
Model Details: A double-blind treatment period of 12 weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 9, 2026

Study Start

April 30, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

March 31, 2029

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

CN(13)