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Coronary Artery DiseasePhase 2NCT06700720

YN001-004 in Patients With Coronary Atherosclerosis in Australia

A Phase 2 study testing Dose 1 YN001, Dose 2 YN001 and Evolocumab in people with Coronary Artery Disease and Coronary Atherosclerotic Disease, run by Beijing Inno Medicine Co., Ltd. at 6 sites in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is to evaluate the efficacy and safety of intravenously administered YN001 in patients with coronary atherosclerosis in Australia. This study will be conducted in eligible participants with a diagnosis of coronary atherosclerosis, and at least 1 coronary artery is blocked determined by coronary computed… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Dose 1 YN001, Dose 2 YN001 and Evolocumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
6 sitesAustralia
Study dates
25 Feb 2026to 22 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fully understand the purposes, features, and methods of the study, and sign the ICF before performing any assessment.
  • Male or female Australia patients between 18 and 75 years.
  • Patients diagnosed with coronary atherosclerosis, and at least 1 vessel with diameter stenosis determined by coronary computed tomography angiography (CTA).
  • 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.
  • Willing and able to comply with the requirements of protocol to the best of the patient's and investigator's knowledge.

Who cannot join

  • 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.
  • Contraindication for coronary CTA (e.g., known history of anaphylactic contrast reactions).
  • Multi-vessel severe disease.
  • Recent acute ST-segment elevation myocardial infarction (STEMI) occurred within 2 weeks prior to randomization.
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  • 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.
  • Prior treatment with CABG, heart transplantation, SAVR/TAVR, etc., or CABG, heart transplantation, SAVR/TAVR, etc., is required or planned during the study.
  • PCI performed within 4 weeks prior to randomization or PCI is required or planned during study treatment.
  • New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction (LVEF) <40%.
  • Recent clinically evident stroke occurred within 6 months prior to randomization (except for TIA).
  • Presenting with history of myopathy/myalgia, or susceptible to myopathy/rhabdomyolysis.
  • Known inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding within 6 months prior to randomization.
  • Evidence of major diseases that not recovered within 2 weeks prior to randomization, or major surgery is expected during the study.
  • 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).
  • Presence of any type of autoimmune disease.
  • Allergy to multiple food or drugs or known sensitivity to any components to be administered during dosing
  • Life expectancy is less than 1 year.
  • Systolic blood pressure of ≥150 mmHg at final screening despite antihypertensive therapy.
  • Known familial hypercholesterolemia
  • Triglycerides≥400 mg/dl (4.5 mmol/l) at final screening.
  • 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.
  • Presence of renal insufficiency.
  • Untreated or inadequately treated hypothyroidism defined by thyroid stimulating hormone (TSH) > 1.5 times ULN at final screening.
  • Poorly controlled (defined by HbA1c > 9%) 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).
  • Current smoker who has smoked an average of≥5 cigarettes (or equivalent) per day over the preceding year.
  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Australia6 sites

  • Albury Wodonga Private Hospital

    Albury, New South Wales, 1125

  • Sunshine Coast University Private Hospital

    Birtinya, Queensland, 4575

  • Canberra Hospital

    Canberra, Australian Capital Territory

  • Altona Clinical Research

    Melbourne, Victoria, 3025

  • Peninsula Heart Centre

    Melbourne, Victoria, 3199

  • John Flynn Private Hospital

    Tugun

Other trials in Australia

About this study

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

This study is to evaluate the efficacy and safety of intravenously administered YN001 in patients with coronary atherosclerosis in Australia. This study will be conducted in eligible participants with a diagnosis of coronary atherosclerosis, and at least 1 coronary artery is blocked determined by coronary computed tomography angiography (CCTA)

Read the detailed description

This is a multicenter, randomized, open label, parallel-group, proof of concept study. It is designed to determine if the study drug, called YN001, administered in addition to evolocumab can effectively reduce the total amount of plaque formed in the coronary artery as measured by CCTA from baseline to week 13.

A total of 24 patients with coronary atherosclerosis are expected to be enrolled and will be randomly assigned in a 1:1 ratio to 1 of 2 YN001 treatment arms (12 patients per arm) with 2 different dose levels for 12 weeks.

The study will be comprised of a maximum 41-day screening period (Day -42-Day -2), a baseline period (Day-1), a treatment and observation period (W1D1- W13D7), and a safety follow-up period (14 days post last dose).

Being tested
Dose 1 YN001, Dose 2 YN001, Evolocumab
Keywords
Coronary Atherosclerosis, Plaque regression
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dose 1 YN001Drug

    Dose 1 YN001 will be administered on Day 1 of each week from Week 1 to Week 13, 13 times in total.

  • Dose 2 YN001Drug

    Dose 2 YN001 will be administered on Day 1 of each week from Week 1 to Week 13, 13 times in total.

  • EvolocumabDrug

    Also called Repatha®

    Evolocumab 140 mg will be administered subcutaneously every 2 weeks.

Study groups in NCT06700720
Study groupRoleWhat they receive
Dose 1 treatment armExperimentalDose 1 YN001 will be administrated intravenously weekly.
Receives: Drug: Dose 1 YN001; Drug: Evolocumab
Dose 2 treatment armExperimentalDose 2 YN001 will be administrated intravenously weekly.
Receives: Drug: Dose 2 YN001; Drug: Evolocumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in coronary plaque characteristics (volume and composition)

    Evaluating YN001 on top of evolocumab therapy in changing coronary plaque volume assessed by coronary computed tomography angiography (CCTA).

    Measured: From baseline to Week 13

Secondary outcomes (7)

  1. Change in mean of mean carotid IMT

    Evaluating YN001 on top of evolocumab therapy in changing carotid intima-media thickness (IMT) assessed by carotid ultrasound.

    Measured: From baseline to Week 13

  2. Change in mean of mean carotid IMT

    Evaluating YN001 on top of evolocumab therapy in changing carotid intima-media thickness (IMT) assessed by carotid ultrasound.

    Measured: From baseline to Week 5

  3. Change in mean of mean carotid IMT

    Evaluating YN001 on top of evolocumab therapy in changing carotid intima-media thickness (IMT) assessed by carotid ultrasound.

    Measured: From baseline to Week 9

  4. Change in mean peri-coronary Fat attenuation index (FAI)

    Evaluating YN001 on top of evolocumab therapy in changing inflammation using the peri-coronary FAI value measured by quantitative CTA analysis.

    Measured: From baseline to Week 13

  5. The safety profile of YN001

    Incidence of Adverse events (AEs)/Serious adverse events (SAEs)

    Measured: From baseline to Week 15

  6. Plasma concentration of total and free drug

    Plasma concentration of total and free drug at pre-dose (0 h) and at the end of infusion

    Measured: From Week 1 to Week 13

  7. Population pharmacokinetics (PK)

    Plasma PK parameter (AUC) and patient covariates of interest will be evaluated graphically and in the population PK model.

    Measured: From Week 1 to Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2024
  2. Study start25 Feb 2026
  3. Primary completion22 Jul 2026
  4. Study completion22 Jul 2026

Why it stopped: The study was terminated at the request of the Sponsor.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06700720
Sponsor's protocol ID
YN001-004
Status last verified
Sep 2026
First submitted
14 Nov 2024
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dose 1 YN001, Dose 2 YN001 and Evolocumab in people with Coronary Artery Disease and Coronary Atherosclerotic Disease, run by Beijing Inno Medicine Co., Ltd. at 6 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated at the request of the Sponsor.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in coronary plaque characteristics (volume and composition) (time frame: From baseline to Week 13). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06700720.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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