If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Phase 2 study for people with Heart Disease
Recruiting Phase 2
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Cannopy Clinical Research | Penrith | NSW | Recruiting |
| Core Research Group Pty Ltd. | Brisbane | QLD | Recruiting |
| Canopy Clinical Research | Altona N. | VIC | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 22 September 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.