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

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Beijing Inno Medicine Co., Ltd.
Study ID
NCT07521007
Phase
PHASE2
Status
Recruiting

Conditions

  • Atherosclerosis
  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • YN001/Placebo 40mg — DRUG
    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 20mg — DRUG
    YN001/Placebo 20mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.
  • YN001/Placebo 0mg — DRUG
    YN001/Placebo 0mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.

Study Details

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.

Key Dates

First listed
Apr 9, 2026
Start date
Jul 31, 2026
Status verified
Sep 2026
Primary completion
Jul 31, 2027
Completion
Mar 31, 2029

Study Design

Enrollment
456 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose 1 YN001/Placebo 40mg
    Dose 1 YN001/Placobo 40mg will be administrated intravenously weekly
  • Experimental: Dose 2 YN001/Placebo 20mg
    Dose 2 YN001/Placebo 20mg will be administrated intravenously weekly
  • Placebo Comparator: Dose 3 YN001/Placebo 0mg
    Dose 3 YN001/Placebo 0mg will be administrated intravenously weekly

Primary Outcome Measure

Relative change from baseline in coronary NCPV at Week 13 [ Time Frame: Baseline to Week 13 ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Heart Center Research, LLCHuntsvilleAlabama35801-4312
Walter Haught, MD
256-519-8472
Thrive Clinical Research Group, LLCCovinaCalifornia91740
Sami Hayek
818-280-4220
Clinical Trials ResearchLincolnCalifornia95648
Jeffrey Wayne, MD
916-434-8230
University of California Irvine Medical Center - Cardiovascular CenterLos AlamitosCalifornia90720
Arnold Seto
562-598-3200
Stanford Health Care General CardiologyStanfordCalifornia94305-2200
Fahim Abbasi, MD
650-723-6459
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorranceCalifornia90502-2006
Matthew Budoff, MD
310-222-3641
Flourish Research - Boca RatonBoca RatonFlorida33434
Richard Goldman
561-756-8206
New Generation of Medical Research, LLC.HialeahFlorida33016-1895
Karelia Ruiz
305-828-9100
HCA Florida Heart InstituteSt. PetersburgFlorida33709
Robert Sanchez, MD
727-490-2100
Emory Healthcare-Emory Heart & Vascular Center - Executive ParkAtlantaGeorgia30303-3049
Modele Ogunniyi
404-616-4440
St. Luke's Clinic - Idaho Cardiology AssociatesMeridianIdaho83642
Brian Nolan
208-322-1680
Southern Illinois University School of MedicineSpringfieldIllinois62781
Abdul Hafiz, MD
217-545-8000
Midwest Heart & Vascular Specialists, LLCOverland ParkKansas66211-1215
Stephen Bloom, MD
913-253-3000
WU School of Medicine - (CAM) - Heart and Vascular CenterSt LouisMissouri63110-1032
Farhan Katchi, MD
314-362-1291
NC Heart and Vascular Research, LLCRaleighNorth Carolina27607
Mohit Pasi
919-784-2300
Javara Inc. - Wake Forest University Health SciencesWinston-SalemNorth Carolina27104-3520
Michael Shapiro, MD
336-713-7251
The Christ HospitalCincinnatiOhio45219
Mark Berlacher, MD
513-585-1777
South Oklahoma Heart Research, LLCOklahoma CityOklahoma73135
Naeem Tahirkheli
405-628-6865
Capital Area Research, LLC - Camp HillCamp HillPennsylvania17011
Venkatesh Nadar, MD
717-695-8722
PharmaTex Research, LLCAmarilloTexas79106
David Brabham
806-355-2581
Pulse Care Heart and VascularCarrolltonTexas75010
Kiran Kumar Mangalpally
214-407-8640
DM Clinical Research - DallasTomballTexas77375
Mustafa Mandviwala
346-550-9559

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