Clinical trial for Atherosclerosis
Official title A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis
ClinicalTrials.gov ID: NCT07521007
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Fully understands the purposes, features, and methods of the study and the possible adverse reactions, and is voluntarily willing to participate in...
- 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: 1) Have clinically evident atherosclerotic CV disease (ASCVD) 2) Meet at least two of the...
- A history of Type 2 diabetes requiring treatment with medication,
- Aged \> 55 years (women) or \> 50 years (men),
You likely can't join 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
- 3 major epicardial coronary arteries with ≥ 70% or left main ≥50% stenosis.
- Acute MI that occurred within 4 weeks prior to randomization.
See the full eligibility criteria
Who can join
- 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...
- 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: 1) 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),
- 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...
What rules you out
- 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
- 3 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...
- 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.
- 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...
- 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).
- Presence of any type of autoimmune disease.
- Allergy to multiple foods or drugs or known sensitivity to any components to be administered during dosing.
- Life expectancy is less than 1 year.
- Systolic blood pressure of ≥ 160 mmHg at final screening despite antihypertensive therapy.
- Triglycerides ≥ 400 mg/dL (4.5 mmol/L) at final screening.
- LDL-C \> 100 mg/dL (2.6 mmol/L) at final screening.
- 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...
- Presence of renal dysfunction, defined by eGFR \< 45 ml/min/1.73m2.
- Untreated or inadequately treated hypothyroidism.
- Poorly controlled Type 2 diabetes mellitus.
- 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Covina, California, United States
- Lincoln, California, United States
- Los Alamitos, California, United States
- Stanford, California, United States
- Torrance, California, United States
- Boca Raton, Florida, United States
- Hialeah, Florida, United States
- St. Petersburg, Florida, United States
- Atlanta, Georgia, United States
- Meridian, Idaho, United States
- Springfield, Illinois, United States
- Overland Park, Kansas, United States
- St Louis, Missouri, United States
- Raleigh, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cincinnati, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Camp Hill, Pennsylvania, United States
- Amarillo, Texas, United States
+ 31 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Covina, California, United States; Lincoln, California, United States; Los Alamitos, California, United States; Stanford, California, United States; Torrance, California, United States and 45 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.