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AtherosclerosisPhase 2PURIFY-TIMI 81NCT07521007

A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis

A Phase 2 study of Atherosclerosis and Coronary Artery Disease, run by Beijing Inno Medicine Co., Ltd. at 56 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is designed to evaluate the efficacy and safety of intravenously administered YN001 in patients diagnosed with coronary atherosclerosis, who are receiving background therapy for cardiovascular (CV) risk factors management. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Atherosclerosis, Coronary Artery Disease
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
456 participants
Where
56 sitesin 4 countries
Study dates
31 Jul 2026to 31 Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Male or female participants between 18 and 80 years (inclusive, at the time of signing the ICF).
  • 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:
  • A history of Type 2 diabetes requiring treatment with medication,
  • Aged > 55 years (women) or > 50 years (men),
Show all 13Show fewer
  • 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.

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, or any planned vaccination during the study treatment period
  • Contraindication for CCTA
  • 3 major epicardial coronary arteries with ≥ 70% or left main ≥50% stenosis.
  • Acute MI that occurred within 4 weeks prior to randomization.
Show all 29Show fewer
  • PCI performed within 2 weeks prior to randomization or PCI is required or planned during study treatment based on clinical indication for revascularization.
  • Clinically evident stroke or transient ischemic attack (TIA) within 6 months prior to randomization.
  • Relapse and highly symptomatic arrhythmia uncontrolled by drugs within the past 3 months.
  • 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.
  • New York Heart Association class III or IV or last known left ventricular ejection fraction (LVEF) was <40%.
  • Carotid endarterectomy or stenting, peripheral arterial revascularization, or abdominal aortic aneurysm repair within 4 weeks prior to randomization.
  • History of myopathy or myositis, or susceptibility to myopathy/rhabdomyolysis (e.g., family history of hereditary myopathy, etc.).
  • History of severe myalgia attributed to statin therapy or other significant concern about statin side effects.
  • Known gastrointestinal ulcers, inflammatory bowel disease, or gastrointestinal/rectal bleeding within 6 months prior to randomization.
  • 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.
  • 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).
  • Presence of any type of autoimmune disease.
  • Allergy to multiple foods or drugs or known sensitivity to any components to be administered during dosing.
  • Life expectancy is less than 1 year.
  • Systolic blood pressure of ≥ 160 mmHg at final screening despite antihypertensive therapy.
  • Triglycerides ≥ 400 mg/dL (4.5 mmol/L) at final screening.
  • LDL-C > 100 mg/dL (2.6 mmol/L) at final screening.
  • 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.
  • Presence of renal dysfunction, defined by eGFR < 45 ml/min/1.73m2.
  • Untreated or inadequately treated hypothyroidism.
  • Poorly controlled 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).
  • 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.

Trial locations and contacts

56 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Jingmei Zhang, Master contact

0086 010 82599080

zhangjingmei@innovmedicine.com

Kaiqi Zong, Master contact

0086 010 82599080

zongkaiqi@innovmedicine.com

56 sites in 4 countries

China25 sites, 25 recruiting

  • Anzhen Hospital

    Beijing, Beijing Municipality, 100029

    Yuyang Liu, MD, 0086 010-64456488, liuyy803803@163.com

    Yuyang Liu, MD

    Recruiting

  • Beijing Jishuitan Hospital

    Beijing, Beijing Municipality, 100035

    Qingwei Ji, MD, 0086 18376642655, jqwl24@163.cou

    Qingwei Ji, MD

    Recruiting

  • Beijing Luhe Hospital

    Beijing, Beijing Municipality, 101100

    Guangyao Zhai, MD, +86 1069543901, drzhaiguangyao@163.com

    Not yet recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130033

    Qian Tong, MD, 0086 13074337289, tongqian187@aliyun.com

    Qian Tong, MD

    Recruiting

  • The Second Xiangya Hospital fo Central South University

    Changsha, Hunan, 410008

    Xinqun Hu, MD, 0086-13307313627, huxinqungs@163.com

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Yong He, MD, 0086 18980602038, zznnyeah@163.com

    Yong He, MD

    Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

    Jianhong Tao, DM, 86-189 8183 8875, Taojianhong06@medmail.com.cn

    Recruiting

  • Daqing People's Hospital

    Daqing, Heilongjiang, 163316

    Shu Zhang, +86-459-6612898, dqsrmyygcp@163.com

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Mingfang Ye, MD, 0086 13960818759, xieheyemingfang@163.com

    Mingfang Ye, MD

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

    Ning Tan, MD, tanning100@126.com

    0086-13903073651, tangning100@126.com

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310006

    Lihong Wang, MD, 0086-13666690598, wlhhz@hotmail.com

    Recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

    Lu Fu, MD, 0086 137 9668 4968, fuluyidayi@163.com

    Lu Fu, MD

    Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

    Kangyu Chen, MD, 0086 18056005099, ustccky@126.com

    Kangyu Chen, MD

    Recruiting

  • The First Affiliated Hospital of Anhui Medical Unversity

    Hefei, An, 230022

    Jianlong Wang, MD, 0086-13681292304, Wjlmll@sina.com

    Recruiting

  • Central Hospital Affiliated to Shandong First Medicial University

    Jinan, Shandong

    Guohai Su, MD, 0086 19953193319, gttstg@163.com

    Recruiting

  • The Second Hospital & Clinical Medical School Lanzhou University

    Lanzhou, Gansu, 730030

    Feng Bai, MD, 0086-13609363049, baifeng@medmail.com.cn

    Recruiting

  • Renji Hospital Shanghai Jiaotong University school of medicine

    Shanghai, Shanghai Municipality, 200001

    Jun Bu, MD, 0086 13601958108, pujun310@hotmail.com

    Jun Bu, MD

    Recruiting

  • Fudan University-Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

    Junbo Ge, MD, 021-64041990, ge.junbo@zs-hospital.sh.cn

    Junbo Ge, MD

    Recruiting

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning, 110015

    Ying Liu, MD, 0086 13840065379, liuyingwangli@126.com

    Ying Liu, MD

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Zhejiang, 215006

    Tingbo Jiang, MD, 0086-18906201122, jiangtingbo6797@163.com

    Recruiting

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality, 300121

    Zhuhua Yao, MD, 0086 13902199877, tjyzhpci@163.com

    Zhuhua Yao, MD

    Recruiting

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

    Tong Liu, MD, 0086 13902183163, liutongdoc@126.com

    Tong Liu, MD

    Recruiting

  • The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU

    Wenzhou, Zhejiang, 325000

    lianpin Wu, MD, 198019@wzhealth.com

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

    Xiaorong Hu, MD, 0086 15927681634, huzrzn@whu.edu.cn

    Xiaorong Hu, MD

    Recruiting

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi, 710068

    Xiling Shou, MD, 0086 18966700335, shouxiling@163.com

    Recruiting

Other trials in China

United States22 sites, 22 recruiting

  • PharmaTex Research, LLC

    Amarillo, Texas, 79106

    David Brabham, 806-355-2581, dgbrabham@hotmail.com

    Recruiting

  • Emory Healthcare-Emory Heart & Vascular Center - Executive Park

    Atlanta, Georgia, 30303-3049

    Modele Ogunniyi, 404-616-4440, modele.ogunniyi@emory.edu

    Not yet recruiting

  • Flourish Research - Boca Raton

    Boca Raton, Florida, 33434

    Richard Goldman, 561-756-8206, rgoldman@flourishresearch.com

    Not yet recruiting

  • Capital Area Research, LLC - Camp Hill

    Camp Hill, Pennsylvania, 17011

    Venkatesh Nadar, MD, 717-695-8722, VNadar@care-research.com

    Recruiting

  • Pulse Care Heart and Vascular

    Carrollton, Texas, 75010

    Kiran Kumar Mangalpally, 214-407-8640, trials@stryderesearch.com

    Not yet recruiting

  • The Christ Hospital

    Cincinnati, Ohio, 45219

    Mark Berlacher, MD, 513-585-1777, Mark.Berlacher@thechristhospital.com

    Not yet recruiting

  • Thrive Clinical Research Group, LLC

    Covina, California, 91740

    Sami Hayek, 818-280-4220, samihayek82@hotmail.com

    shayek@foothillcardiology.com

    Not yet recruiting

  • New Generation of Medical Research, LLC.

    Hialeah, Florida, 33016-1895

    Karelia Ruiz, 305-828-9100, kareliar@ngmresearch.com

    Recruiting

  • Heart Center Research, LLC

    Huntsville, Alabama, 35801-4312

    Walter Haught, MD, 256-519-8472, hhaught@theheartcenter.md

    Recruiting

  • Clinical Trials Research

    Lincoln, California, 95648

    Jeffrey Wayne, MD, 916-434-8230, jwaynemd@ctrsites.com

    Not yet recruiting

  • University of California Irvine Medical Center - Cardiovascular Center

    Los Alamitos, California, 90720

    Arnold Seto, 562-598-3200, arnold.seto@va.gov

    Not yet recruiting

  • St. Luke's Clinic - Idaho Cardiology Associates

    Meridian, Idaho, 83642

    Brian Nolan, 208-322-1680, bnolan@slhs.org

    Not yet recruiting

  • South Oklahoma Heart Research, LLC

    Oklahoma City, Oklahoma, 73135

    Naeem Tahirkheli, 405-628-6865, ntahirkheli@okheart.com

    Not yet recruiting

  • Midwest Heart & Vascular Specialists, LLC

    Overland Park, Kansas, 66211-1215

    Stephen Bloom, MD, 913-253-3000, sbloom@kc.rr.com

    Recruiting

  • NC Heart and Vascular Research, LLC

    Raleigh, North Carolina, 27607

    Mohit Pasi, 919-784-2300, mohit.pasi2@unchealth.unc.edu

    Not yet recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62781

    Abdul Hafiz, MD, 217-545-8000, ahafiz96@siumed.edu

    Not yet recruiting

  • WU School of Medicine - (CAM) - Heart and Vascular Center

    St Louis, Missouri, 63110-1032

    Farhan Katchi, MD, 314-362-1291, katchif@wustl.edu

    Recruiting

  • HCA Florida Heart Institute

    St. Petersburg, Florida, 33709

    Robert Sanchez, MD, 727-490-2100, robert.sanchez7@hcahealthcare.com

    Recruiting

  • Stanford Health Care General Cardiology

    Stanford, California, 94305-2200

    Fahim Abbasi, MD, 650-723-6459, fahim@stanford.edu

    Not yet recruiting

  • DM Clinical Research - Dallas

    Tomball, Texas, 77375

    Mustafa Mandviwala, 346-550-9559, drmandviwala.ns@dmclinical.com

    Not yet recruiting

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502-2006

    Matthew Budoff, MD, 310-222-3641, mbudoff@lundquist.org

    Recruiting

  • Javara Inc. - Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27104-3520

    Michael Shapiro, MD, 336-713-7251, owen.spitz@javararesearch.com

    Not yet recruiting

Other trials in United States

Canada6 sites, 6 recruiting

  • London Health Sciences Centre

    London, Ontario, N5A 5A5

    Habib Khan, 519-663-3197, habib.khan@lhsc.on.ca

    Not yet recruiting

  • North York Diagnostic and Cardiac Centre

    North York, Ontario, M6B 3H7

    Subodh Verma, MD, 416-436-0244, subodh.verma@unityhealth.to

    Not yet recruiting

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

    John Graham, 416-864-6060, John.Graham@unityhealth.to

    Not yet recruiting

  • Toronto General Hospital - University Health Network

    Toronto, Toronto, M5G 2N2

    Jacob Udell, 416-340-4800, jay.udell@utoronto.ca

    Not yet recruiting

  • Cardiac Clinic

    Vaughan, Ontario, L6A 4N9

    Navneet Singh, 905-417-3001, navneet.singh@thp.ca

    Not yet recruiting

  • St. Boniface Hospital

    Winnipeg, Manitoba, R2H 2A6

    Shuangbo Liu, 204-237-2793, sliu@sbgh.mb.ca

    Not yet recruiting

Other trials in Canada

Australia3 sites, 3 recruiting

  • Canopy Clinical Research

    Altona N., Victoria, 3025

    Oscar Walsh, MD, 0061 03 9968 7601, owalsh@canopycr.com.au

    Recruiting

  • Core Research Group Pty Ltd.

    Brisbane, Queensland, 4064

    David Colquhou, MD, 614-1184-2788, d.colquhoun@uq.edu.au

    Recruiting

  • Cannopy Clinical Research

    Penrith, New South Wales, 2750

    Karen Kaluhin, MD, 0061 0491 276 512, kkaluhin@canopycr.com.au

    Recruiting

Other trials in Australia

About this study

Official title: A Randomized, Multicenter, Double-Blind, Parallel, Placebo-controlled Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of YN001 in Adults With Coronary Atherosclerosis

This study is designed to evaluate the efficacy and safety of intravenously administered YN001 in patients diagnosed with coronary atherosclerosis, who are receiving background therapy for cardiovascular (CV) risk factors management.

Read the detailed description

This is a multinational, multicenter, randomized, parallel, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of intravenously administered YN001 compared with placebo in participants with coronary atherosclerosis who are receiving background therapy for CV risk factors management.

A total of 456 participants are expected to be enrolled. The study will consist of a maximum 12-week screening/Baseline period, followed by a 12-week blinded treatment period, a 30-day safety follow-up, and a long-term follow-up period through Week 96 (approximately 2 years after randomization).

Being tested
YN001/Placebo 40mg, YN001/Placebo 20mg, YN001/Placebo 0mg
Keywords
Plaque regression, Plaque stabilization
Medical subject headings
Atherosclerosis, Coronary Artery Disease

What participants receive

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

  • YN001/Placebo 40mgDrug

    Dose 1 YN001/Placebo 40mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.

  • YN001/Placebo 20mgDrug

    YN001/Placebo 20mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.

  • YN001/Placebo 0mgDrug

    YN001/Placebo 0mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.

Study groups in NCT07521007
Study groupRoleWhat they receive
Dose 1 YN001/Placebo 40mgExperimentalDose 1 YN001/Placobo 40mg will be administrated intravenously weekly
Receives: Drug: YN001/Placebo 40mg
Dose 2 YN001/Placebo 20mgExperimentalDose 2 YN001/Placebo 20mg will be administrated intravenously weekly
Receives: Drug: YN001/Placebo 20mg
Dose 3 YN001/Placebo 0mgPlacebo comparatorDose 3 YN001/Placebo 0mg will be administrated intravenously weekly
Receives: Drug: YN001/Placebo 0mg

What is being measured

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

  1. Relative change from baseline in coronary NCPV at Week 13

    Relative change in coronary NCPV from baseline to Week 13 as determined by coronary computed tomography angiography (CCTA)

    Measured: Baseline to Week 13

Secondary outcomes (13)

  1. Absolute change from baseline in carotid intima-media thickness (IMT) at Week 13

    Absolute change in carotid IMT from baseline to Week 13 as determined by carotid ultrasound.

    Measured: From baseline to Week 13

  2. Absolute change from baseline in carotid intima-media thickness (IMT) at Week 9

    Absolute change from baseline in carotid intima-media thickness (IMT) at Week 9

    Measured: From baseline to Week 9

  3. Relative change from baseline in carotid intima-media thickness (IMT) at Week 13

    Relative change in carotid IMT from baseline to Week 13 as determined by carotid ultrasound

    Measured: From baseline to Week 13

  4. Relative change in the maximum thickness and area of carotid plaque at Week 9, and Week 13

    Relative change in the maximum thickness and area of carotid plaque from baseline to Week 9, and Week 13 as determined by carotid ultrasound

    Measured: From baseline to Week 9 and Week 13

  5. Relative change in coronary Percent Atheroma Volume (PAV) at Week 13

    Relative change in coronary Percent Atheroma Volume (PAV) from baseline to Week 13 as determined by CCTA

    Measured: From baseline to Week 13

  6. Relative change in coronary Low Attenuation Plaque Volume(LAPV) at Week 13

    Relative change in coronary LAPV from baseline to Week 13 as determined by CCTA.

    Measured: From baseline to week 13

  7. Relative changes in coronary NCPV, PAV, TAV, and LAPV from baseline at 48 week

    Relative changes in coronary NCPV, PAV, TAV, and LAPV from baseline to Week 48 as determined by CCTA

    Measured: From baseline to week 48

  8. Absolute change in coronary NCPV at week 13 and week 48

    Absolute change in coronary NCPV from baseline to Week 13 and Week 48 as determined by CCTA

    Measured: From baseline to week 13 and week 48

  9. Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)

    Time to the first occurrence of the MACE, composite of CV death, myocardial infarction (MI), ischemic stroke, urgent coronary revascularization, or hospitalization for unstable angina

    Measured: From randomization to Week 96

  10. The safety profile of YN001

    Incidence of treatment emergent adverse event (TEAE)/serious adverse event (SAE)/adverse event of special interest (AESI)

    Measured: From baseline to Week 13

  11. Immunogenicity (ADA) analysis

    Incidence of anti-drug antibodies (ADA) formation

    Measured: From baseline to Week 13

  12. Immunogenicity (APA) analysis

    Incidence of anti-PEG antibodies (APA) formation

    Measured: From baseline to Week 17

  13. YN001 concentrations analysis in plasma

    Sparse blood samples will be collected, and these concentrations are intended to be pooled with other studies to develop/update pharmacometric models

    Measured: From baseline 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 posted9 Apr 2026
  2. Study start31 Jul 2026
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Mar 2029 (estimated)

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
Model description
A double-blind treatment period of 12 weeks
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
456 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07521007
Sponsor's protocol ID
YN001-203
Other IDs
IND 157167
Acronym
PURIFY-TIMI 81
Status last verified
Oct 2026
First submitted
2 Apr 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Atherosclerosis and Coronary Artery Disease, run by Beijing Inno Medicine Co., Ltd. at 56 sites in 4 countries.

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 13 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in China, United States, Canada, 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Jingmei Zhang, Master (0086 010 82599080, zhangjingmei@innovmedicine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative change from baseline in coronary NCPV at Week 13 (time frame: 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 NCT07521007.

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 5 Nov 2026.

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