Evaluating YN001 for patients with coronary atherosclerosis in Australia

A Phase Ⅱa Clinical Study to Evaluate the Efficacy and Safety of YN001 in Patients With Coronary Atherosclerosis in Australia

This study is testing if a new treatment called YN001 can help reduce plaque in the arteries of people with coronary atherosclerosis when used alongside another medication.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Inno Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: evolocumab
• Locations: 7 sites (Canberra, Australian Capital Territory and 6 other locations)
• Trial ID: NCT06700720 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of YN001, administered intravenously, in patients diagnosed with coronary atherosclerosis. It is a multicenter, randomized, open-label, parallel-group study designed to assess whether YN001 can effectively reduce plaque in coronary arteries when combined with evolocumab. A total of 12 participants will be enrolled and randomly assigned to two different dose levels of YN001 for a treatment period of 12 weeks, followed by a safety follow-up. The primary measurement of efficacy will be the change in plaque volume as assessed by coronary computed tomography angiography (CCTA).

Who should consider this trial

Good fit: Ideal candidates are males and females aged 18 to 75 with a diagnosis of coronary atherosclerosis and at least one blocked coronary artery.

Not a fit: Patients who have received other investigational drugs within the last 30 days or have contraindications to the study drug may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce coronary artery plaque, potentially improving heart health and reducing cardiovascular events for patients.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in targeting plaque regression, suggesting potential for success.

Eligibility criteria

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.

Where this trial is running

Canberra, Australian Capital Territory and 6 other locations

• Canberra Hospital — Canberra, Australian Capital Territory, Australia (Recruiting)
• Albury Wodonga Private Hospital — Albury, New South Wales, Australia (Recruiting)
• Sunshine Coast University Private Hospital — Birtinya, Queensland, Australia (Recruiting)
• Core Research Group Pty Ltd — Milton, Queesland, Australia (Withdrawn)
• Altona Clinical Research — Melbourne, Victoria, Australia (Recruiting)
• Peninsula Heart Centre — Melbourne, Victoria, Australia (Recruiting)
• John Flynn Private Hospital — Tugun, Australia (Not_yet_recruiting)

Study contacts

• Study coordinator: Jean Zhang

Conditions Coronary Artery Disease; Coronary Atherosclerotic Disease; Coronary Atherosclerosis; Plaque regression