YN001-004 in Patients With Coronary Atherosclerosis in Australia

NCT06700720 | Recruiting Phase 2

• 1 other identifier: YN001-004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

Brief 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 tomography angiography (CCTA)

Conditions

Coronary Artery Disease; Coronary Atherosclerotic Disease

Keywords

Coronary Atherosclerosis; Plaque regression

Outcome Measures

Primary Outcomes (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).

  From baseline to Week 13

Secondary Outcomes (7)

• Change in mean of mean carotid IMT

  From baseline to Week 13

• Change in mean of mean carotid IMT

  From baseline to Week 5

• Change in mean of mean carotid IMT

  From baseline to Week 9

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

  From baseline to Week 13

• The safety profile of YN001

  From baseline to Week 15

Other Outcomes (4)

• Immunogenicity（ADA） analysis

  From Week 1 to Week 13

• Immunogenicity （APA）analysis

  From screening to Week 13

• Exploratory dose-response analysis of plaque volume

  From Week 1 to Week 13

Study Arms (2)

Dose 1 treatment arm

EXPERIMENTAL

Dose 1 YN001 will be administrated intravenously weekly.

Drug: Dose 1 YN001; Drug: Evolocumab

Dose 2 treatment arm

EXPERIMENTAL

Dose 2 YN001 will be administrated intravenously weekly.

Drug: Dose 2 YN001; Drug: Evolocumab

Interventions

Dose 1 YN001 DRUG

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

Dose 1 treatment arm

Dose 2 YN001 DRUG

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

Dose 2 treatment arm

Evolocumab DRUG

Evolocumab 140 mg will be administered subcutaneously every 2 weeks.

Also known as: Repatha®

Dose 1 treatment arm; Dose 2 treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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.
• 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.
• 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).

Sponsors & Collaborators

• Beijing Inno Medicine Co., Ltd.: lead

Study Sites (7)

Canberra Hospital

Canberra, Australian Capital Territory, Australia

RECRUITING

Albury Wodonga Private Hospital

Albury, New South Wales, 1125, Australia

RECRUITING

Sunshine Coast University Private Hospital

Birtinya, Queensland, 4575, Australia

RECRUITING

Core Research Group Pty Ltd

Milton, Queesland, Australia

WITHDRAWN

Altona Clinical Research

Melbourne, Victoria, 3025, Australia

RECRUITING

Peninsula Heart Centre

Melbourne, Victoria, 3199, Australia

RECRUITING

John Flynn Private Hospital

Tugun, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Teresa Chen, PhD

  Beijing Inno Medicine Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Jean Zhang

CONTACT

861082599080; zhangjing@innovmedicine.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 22, 2024
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

AU (7)