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NCT07521007
A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis
Conditions: Atherosclerosis, Coronary Artery Disease
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 456
Sponsor: Beijing Inno Medicine Co., Ltd.
Location: Heart Center Research, LLC Huntsville Alabama
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT07521007). StuddyBuddy aggregates publicly available trial information.