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New drug aims to shrink heart plaque in australian trial

NCT ID NCT06700720

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new medicine called YN001 in people with coronary atherosclerosis (hardening of the arteries in the heart). The goal is to see if YN001 can reduce plaque buildup in the arteries when added to standard care. About 24 adults in Australia with at least one blocked artery will receive the drug intravenously. The study focuses on safety and changes in plaque seen on CT scans.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Fully understand the purposes, features, and methods of the study, and sign the ICF before performing any assessment. 2. Male or female Australia patients between 18 and 75 years. 3. Patients diagnosed with coronary atherosclerosis, and at least 1 vessel with diameter stenosis determined by coronary computed tomography angiography (CTA). 4. Female patients must be non-pregnant and non-lactating, and females of childbearing potential (including a female partner of a male patient) must agree to use 1 effective contraception method from the screening period to 3 months after receiving their last dose of the study drug. In addition, male patients must be willing to refrain from sperm donation during this time. 5. Willing and able to comply with the requirements of protocol to the best of the patient'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. 4. Contraindication for coronary CTA (e.g., known history of anaphylactic contrast reactions). 5. Multi-vessel severe disease. 6. Recent acute ST-segment elevation myocardial infarction (STEMI) occurred within 2 weeks prior to randomization. 7. Relapse and highly symptomatic arrhythmia uncontrolled by drugs within the past 3 months, such as ventricular tachycardia, atrial fibrillation with rapid ventricular rate and paroxysmal supraventricular tachycardia. 8. Prior treatment with CABG, heart transplantation, SAVR/TAVR, etc., or CABG, heart transplantation, SAVR/TAVR, etc., is required or planned during the study. 9. PCI performed within 4 weeks prior to randomization or PCI is required or planned during study treatment. 10. New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction (LVEF) \<40%. 11. Recent clinically evident stroke occurred within 6 months prior to randomization (except for TIA). 12. Presenting with history of myopathy/myalgia, or susceptible to myopathy/rhabdomyolysis. 13. Known inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding within 6 months prior to randomization. 14. Evidence of major diseases that not recovered within 2 weeks prior to randomization, or major surgery is expected during the study. 15. Presenting with history of malignancy (except in patients who have been disease-free \>5 years; or whose only malignancy has been basal or squamous cell skin carcinoma). 16. Presence of any type of autoimmune disease. 17. Allergy to multiple food or drugs or known sensitivity to any components to be administered during dosing 18. Life expectancy is less than 1 year. 19. Systolic blood pressure of ≥150 mmHg at final screening despite antihypertensive therapy. 20. Known familial hypercholesterolemia 21. Triglycerides≥400 mg/dl (4.5 mmol/l) at final screening. 22. Active liver disease or hepatic dysfunction defined by any of ALT, AST, or total bilirubin \> 2 times upper limit of normal (ULN) at final screening. 23. Presence of renal insufficiency. 24. Untreated or inadequately treated hypothyroidism defined by thyroid stimulating hormone (TSH) \> 1.5 times ULN at final screening. 25. Poorly controlled (defined by HbA1c \> 9%) type 2 diabetes mellitus. 26. 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). 27. Current smoker who has smoked an average of≥5 cigarettes (or equivalent) per day over the preceding year. 28. 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 patient to participate in this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albury Wodonga Private Hospital

    RECRUITING

    Albury, New South Wales, 1125, Australia

  • Altona Clinical Research

    RECRUITING

    Melbourne, Victoria, 3025, Australia

  • Canberra Hospital

    RECRUITING

    Canberra, Australian Capital Territory, Australia

  • Core Research Group Pty Ltd

    WITHDRAWN

    Milton, Queesland, Australia

  • John Flynn Private Hospital

    NOT_YET_RECRUITING

    Tugun, Australia

  • Peninsula Heart Centre

    RECRUITING

    Melbourne, Victoria, 3199, Australia

  • Sunshine Coast University Private Hospital

    RECRUITING

    Birtinya, Queensland, 4575, Australia

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