AzTrials
AzTrials

Ischemic Cerebral InfarctionPhase 3ORISNCT07242599

Ongericimab Injection Reducing Recurrence of Ischemic Stroke

A Phase 3 study testing High target group and Low target group in people with Ischemic Cerebral Infarction, run by Beijing Tiantan Hospital at 199 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The Oris trial aims to evaluate whether the use of Ongericimab injection in patients with atherosclerotic ischemic cerebrovascular disease within 3 months of onset can reduce the risk of recurrent major cardiovascular events by achieving lower lipid-lowering target values (LDL-C < 1.4 mmol/L). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Cerebral Infarction
What is being tested?
High target group and Low target group
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,810 participants
Where
199 sitesChina
Study dates
22 Apr 2026to 1 Apr 2029
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Obtaining informed consent；
  • Age ≥18 years；
  • Patients with ischemic stroke within 3 months( NIHSS<15 before randomization);
  • Presence of ≥50% stenosis in major intracranial or extracranial arteries, and related to the symptoms of the current episode or the location of infarction；
  • LDL-C ≥ 70 mg/dL (1.8 mmol/L) at screening.

Who cannot join

  • History of cerebral hemorrhage at any time (microhemorrhages present only on SWI are not an exclusion criterion)
  • Hemorrhage or other pathological neurological conditions on baseline brain CT/MRI (e.g., vascular malformations, tumors, abscesses, or common non-ischemic brain diseases like multiple sclerosis);
  • Presence of isolated sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness or vertigo, but no evidence of recent infarction on baseline head CT or MRI;
  • Unable to complete the assessment of intracranial and extracranial arterial stenosis before randomization
  • mRS score≥2 before onset (based on assessment of medical history);
  • Stroke caused by angioplasty/vascular surgery;
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  • Cardioembolic stroke caused by atrial fibrillation, artificial heart valves, endocarditis, mitral stenosis, sinus node dysfunction, etc.
  • Most recent fasting triglycerides >400 mg/dL (4.5 mmol/L) prior to randomization;
  • Uncontrolled hypertension (SBP >180 mmHg or DBP >110 mmHg);
  • Hypothyroidism diagnosed within 1 month before randomization.
  • Severe renal impairment (eGFR <30 mL/min/1.73m²);
  • Active liver disease or dysfunction (AST/ALT >3×ULN within 30 days pre-randomization);
  • NYHA Class III/IV heart failure within 1 year prior to randomization;
  • Life-limiting non-cardiovascular diseases (life expectancy <1 years);
  • Malignancy within 10 years (excluding adequately treated basal cell carcinoma, cervical CIS, DCIS, or stage 1 prostate cancer);
  • Known hypersensitivity to monoclonal antibody therapies;
  • PCSK9 inhibitor use within 3 months before randomization.
  • Participation in other drug/device trials within 30 days;
  • Women of childbearing potential without contraception, pregnancy, or lactation;
  • Inability to understand or comply with the study due to mental illness, cognitive, or emotional disorders, or other reasons deemed unsuitable for participation in the study by the investigator.

Trial locations and contacts

199 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yongjun Wang, MD contact

+86 13911172565

yongjunwang111@aliyun.com

Liye Dai, MD contact

+86 15010545290

yezidailiye@163.com

199 sites in 1 country

China199 sites

  • Puding County People's Hospital

    Anshun, Guizhou, 562100

    Yunfei Zhao, 18585890623, 18585890623@wo.cn

  • Baise City People's Hospital

    Baise City, Guangxi, 533099

    Shaofa Li, 13977693812, lishaofa88@sina.com

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 071000

    Weiying Di, 13931239834, diweiying@126.com

  • Hebei Tang County People's Hospital

    Baoding, Hebei, 071030

    Chunyu Di, 15081246655, 15081246655@139.com

  • The No.2 Hospital Of Baoding

    Baoding, Hebei, 071051

    Fengli Zhao, 17732288689, fenglizhaovip@163.com

  • Baotou City Central Hospital

    Baotou, Inner Mongolia, 014040

    Yu Fan, 13654729916, 13654729916@163.com

  • Sinopharm North Hospital

    Baotou, Inner Mongolia, 221116

    Min Wang, 13474986532, bfyysjnkwm@163.com

  • Bayannur Hospital

    Bayan Nur, Inner Mongolia, 015000

    Wen Gao, 17604788171, 122805722@qq.com

  • Wuyuan County People's Hospital

    Bayan Nur, Inner Mongolia, 015100

    Yongming Chen, 15647811211, cyongm2010@163.com

  • The First Hospital of Fangshan District, Beijing

    Beijing, Beijing Municipality, 102499

    Jianhua Li, 13552375686, lijianhua19730521@163.com

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing

    Yongjun Wang, MD, +86 13911172565, yongjunwang111@aliyun.com

    Liye Dai, MD, +86 15010545290, yezidailiye@163.com

  • General Hospital of Benxi Iron

    Benxi, Liaoning, 117000

    Hang Zhao, 18041440349, zhaohang75@163.com

  • Benxi Central Hospital

    Benxi, Liaoning, 117100

    Chengguang Song, 15041488936, scg2011@163.com

  • Yangxin County People's Hospital

    Binzhou, Shandong, 251800

    Jishuang Kang, 18054566072, yxkangjs123@163.com

  • Binzhou Medical University Hospital

    Binzhou, Shandong, 256603

    Wenbin Ma, 13615438722, mawbin@163.com

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130033

    Ying Xing, 13844021603, xingying1970@163.com

  • Taoyuan People'S Hospital

    Changde, Hunan, 415700

    Jing Lei, 13787887931, 419136036@qq.com

  • Liuyang Jili Hospital

    Changsha, Hunan, 410399

    Yuzhang Bei, 13487494488, 277475748@qq.com

  • Changzhi People's Hospital

    Changzhi, Shanxi, 046000

    Bingxia Li, 15035501050, llbbxx2001@126.com

  • Chenzhou 3rd People's Hospital

    Chenzhou, Hunan, 423000

    Huixiang Tang, 13487867548, 2277024052@qq.com

  • Chenzhou No.1 People's Hospital

    Chenzhou, Hunan, 423099

    Xiaoxi Yao, 13637353120, yaoxxtt@126.com

  • Affiliated Hospital of Chifeng University

    Chifeng, Inner Mongolia, 024000

    Weili Zhao, 13948162665, wlzhao1968@163.com

  • Chifeng Hospital of Traditional Chinese and Mongolian Medicine

    Chifeng, Inner Mongolia, 024005

    Guozhi Lu, 13722169555, gz9555@sina.com

  • Chifeng City Center Hospital Ningcheng County

    Chifeng, Inner Mongolia, 024200

    Lijuan Dou, 13739934271, 441855613@qq.com

  • Ningcheng County Hospital of Traditional Chinese and Mongolian Medicine

    Chifeng, Inner Mongolia, 024200

    Yanqing Bai, 13840961618, yanqing_006@163.com

  • Chongqing Sanbo Changan Hospital

    Chongqing, Chongqing Municipality, 400023

    Mingli Chen, 18502377051, 836985160@qq.com

  • The Fifth People's Hospital of Chongqing

    Chongqing, Chongqing Municipality, 400062

    Ge Jin, 15123202128, wysnjg@163.com

  • The First Affiliated Hospital of Chongqing Medical and Pharmaceutical College

    Chongqing, Chongqing Municipality, 401334

    Hao Xie, 13594687518, 574209771@qq.com

  • Central Hospital of Dalian University of Technology （Dalian Municipal Central Hospital）

    Dalian, Liaoning, 116000

    Hongling Zhao, 13998515718, zhaohongling2000@126.com

  • The first affiliated hospital of Dalian Medical University

    Dalian, Liaoning, 116011

    Bingwei Zhang, 18098876286, zhangbingweidoc@163.com

  • Dalian University Affiliated Xinhua Hospital

    Dalian, Liaoning, 116021

    Yi Wang, 13019455197, wangyi226626@sina.com

  • Dalian lvshunkou district traditional Chinese medicine hospital

    Dalian, Liaoning, 116041

    Changhao Jiang, 18640937766, jiangchanghao2@163.com

  • Dalian Jinzhou District First People's Hospital

    Dalian, Liaoning, 116199

    Huijuan Sun, 18018902263, sunhuijuan71@163.com

  • Wafangdian Third Hospital Co., Ltd.

    Dalian, Liaoning, 116300

    Xingguo Jiang, 15164091312, 174983596@qq.com

  • Dandong Central Hospital

    Dandong, Liaoning, 118000

    Cheng Bi, 15841587837, 15841587837@163.com

  • Dandong First Hospital

    Dandong, Liaoning, 118000

    Lishu Wan, 13591528175, wanwan0409@163.com

  • Daqing No.4 hospital

    Daqing, Heilongjiang, 163000

    Yanhui Wang, 13159995858, 1636522400@qq.com

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang, 163001

    Xuhai Gong, 13349491212, 903211995@qq.com

  • DA QING LongNan Hospital

    Daqing, Heilongjiang, 163453

    Kai Hui, 13059043677, huikai2007dq@sina.com

  • People's Hospital of Qihe County

    Dezhou, Shandong, 251100

    Haitao Li, 13869215737, userfiled@126.com

  • Ningjin People's Hospital

    Dezhou, Shandong, 253499

    Chunjie Yang, 13869268655, yangchunjie@yeah.net

  • Minxian County Hospital of Traditional Chinese Medicine

    Dingxi, Gansu, 748400

    Zhixiang Liu, 13679324242, 807851367@qq.com

  • The Second People's Hospital of Dongying

    Dongying, Shandong, 257335

    Chunlei Li, 13954693492, lichunlei1223@163.com

  • Liaoning Health Industry Group Fukuang General Hospital

    Fushun, Liaoning, 113008

    Hong Zhang, 15694136301, zhanghong429@163.com

  • Fuyang People's Hospital

    Fuyang, Anhui, 236004

    Jinghong Lu, 13966839305, lujinghong2002@126.com

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, 570311

    Bin Chen, 18489966998, hyefy12452@muhn.edu.cn

  • Cixian People's Hospital

    Handan, Hebei, 056500

    Jinhai Yan, 13930033143, Wuppcxrmyy2023@163.com

  • Weixian People's Hospital

    Handan, Hebei, 056800

    Xuekong Li, 13803290087, 1006519700@qq.com

  • HanDan Central Hospital

    Handan, Hebei, 057150

    Huiyong Huo, 18931038270, 1577228094@qq.com

  • Qiuxian County People's Hospital

    Handan, Hebei, 057450

    Xin Wang, 13832045118, qxyywx@163.com

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

    Di Zhong, 13766851510, dityan@163.com

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

    Peifang Liu, 18004661136, liupeifang2299@163.com

  • Beian No.1 People's Hospital

    Harbin, Heilongjiang, 164000

    Kailu Sun, 18245677887, 137160874@qq.com

  • Hebi Coal Industry (Group) Co., Ltd. General Hospital

    Hebi, Henan, 458031

    Yanhua Zhang, 13939238229, hnhbzyh@163.com

  • No.1 People'S Hospital of Heihe

    Heihe, Heilongjiang, 164300

    Xuefei Liu, 18645663506, 3926231393@qq.com

  • Hejian People's Hospital

    Hejian, Hebei, 062450

    Dongqi Liu, 13700382558, 2543165501@qq.com

  • Hengshui People's Hospital

    Hengshui, Hebei, 053000

    Xiaoli Wang, 18633680078, hshywxl@163.com

  • The NO.4 People's Hospital of Hengshui

    Hengshui, Hebei, 053000

    Jianling Zhang, 13191905169, hstczjl@126.com

  • The NO.4 People's Hospital of Hengshui

    Hengshui, Hebei, 053000

    Jingwen Cui, 13292236603, zlh5176@163.com

  • Yuncheng County People's Hospital

    Heze, Shandong, 274799

    Guoqiang Yang, 15965855123, 12601830@qq.com

  • Tuoketuo County Hospital

    Hohhot, Inner Mongolia, 010200

    Youjun Liu, 13347128287, 117966323@qq.com

  • Lianshui County People's Hospital

    Huai'an, Jiangsu, 223400

    Yadong Yu, 15952336789, Ls_yyd@163.com

  • Huizhou First Hospital

    Huizhou, Guangdong, 516003

    Chunsheng Cai, 15819870919, uksung@163.com

  • Huidong People'S Hospital

    Huizhou, Guangdong, 516300

    Tingna Zhu, 18933541720, 184867592@qq.com

  • Huludao Central Hospital

    Huludao, Liaoning, 125001

    Changming Xu, 15382008866, zxyyxcm_hld@163.com

  • HuZhou Central Hospital

    Huzhou, Zhejiang, 313000

    Bing Zhang, 13705723721, sjnkhz@163.com

  • The First Affiliated Hospital of Jiamusi University

    Jiamusi, Heilongjiang, 154000

    Yuling Jin, 15694548223, 975795903@qq.com

  • The Hongda Hospital of Jiamusi University

    Jiamusi, Heilongjiang, 154000

    Changsi Ai, 19845080777, 61834444@qq.com

  • Jiaozuo Coal Mining Group Co., Ltd. Central Hospital

    Jiaozuo, Henan, 454001

    Dongyun Chen, 13938198933, zhennyan@126.com

  • The First Affiliated Hospital of Henan Polytechnic University (Jiaozuo Second People's Hospital)

    Jiaozuo, Henan, 454001

    Zhenyu Kong, 15239110006, ysynkzy@126.com

  • Xiuwu County People's Hospital

    Jiaozuo, Henan, 454350

    Guangming Kang, 13938146566, 51060276@qq.com

  • Qinyang City Hospital of Traditional Chinese Medicine

    Jiaozuo, Henan, 454550

    Gongping Zhu, 13782701968, zgp2@126.com

  • Qinyang People's Hospital

    Jiaozuo, Henan, 454550

    Jiafeng Dong, 15939165367, 857844084@qq.com

  • Mengzhou Fuxing hospital

    Jiaozuo, Henan, 454750

    Dali Li, 13938140266, drlidali@163.com

  • Mengzhou Hospital of Traditional Chinese Medicine

    Jiaozuo, Henan, 454750

    Baoguo Xue, 13569165207, xuebg123@sohu.com

  • Haiyan People's Hospital

    Jiaxing, Zhejiang, 314399

    Zhenhua Xi, 13819069729, sj-xizh@163.com

  • The First People's Hospital of Jingdezhen

    Jingdezhen, Jiangxi, 333099

    Minghua Cao, 13979881026, xiongfushui@126.com

  • Qufu People's Hospital

    Jining, Shandong, 273100

    Huijie Sun, 15265750190, shenqiaoqi1988@126.com

  • Jiujiang No.1 People's Hospital

    Jiujiang, Jiangxi, 332000

    Hongbing Nie, 13607927780, niehongbin1@126.com

  • Shanghai General Hospital Jiuquan Hospital

    Jiuquan, Gansu, 735008

    Baihai Guo, 13830156690, 908137952@qq.com

  • Mudanjiang Hospital of Beidahuang Group

    Jixi, Heilongjiang, 158300

    Chuanbao Yu, 15846446677, msyuchuanbao@163.com

  • Jiyuan Hospital of Traditional Chinese Medicine

    Jiyuan, Henan, 459001

    Hongqin Yang, 13938170576, yhq19720828@126.com

  • The People's Hospital of the Qiandongnan Miao and Dong Autonomous Prefecture

    Kaili, Guizhou, 556099

    Xiaosong Li, 13312448228, 2575051958@qq.com

  • Gansu Provincial Maternity and Child-care Hospital(Gansu Provincial Central Hospital)

    Lanzhou, Gansu, 730070

    Rong Yin, 13919930466, yin_rong_@163.com

  • The First People's Hospital of Yuzhong County

    Lanzhou, Gansu, 730100

    Xiaopo Shen, 18153988002, silencesxp@163.com

  • Liaocheng Brain Hospital

    Liaocheng, Shandong, 252000

    Xinbo Zhuang, 13346258600, 10692996@qq.com

  • Liaocheng City Central Hospital

    Liaocheng, Shandong, 252001

    Xiting Zhang, 18063559551, 2844168014@qq.com

  • The Third People Hospital in Liaocheng

    Liaocheng, Shandong, 252006

    Bo Feng, 18563528510, 47702306@qq.com

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252037

    Dong Guo, 13396258699, guodonglc8699@163.com

  • The people's Hospital of Linqing

    Liaocheng, Shandong, 252699

    Wei Zhang, 13563532266, 13563532266@126.com

  • The People's Hospital of Gaotang

    Liaocheng, Shandong, 252899

    Chunlei Zhang, 13869543363, 13396258808@189.cn

  • Linfen Central Hospital

    Linfen, Shanxi, 041000

    Hongguo Dai, 15935767592, daihongguo3199@163.com

  • Lishui Central Hospital

    Lishui, Zhejiang, 323000

    Xiao Peng, 13626783639, pengxiao2508@163.com

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi, 545005

    Liya Pan, 13977250101, Panlya@126.com

  • Lianyuan People's Hospital

    Loudi, Hunan, 417100

    Yiyong Zhang, 13975782626, zhang81520@qq.com

  • Luoyang First People's Hospital

    Luoyang, Henan, 471002

    Jinfeng Shi, 13633871485, 540715474@qq.com

  • Luoyang Central Hospital

    Luoyang, Henan, 471009

    Zhihui Duan, 18537919198, duanzhihui76@126.com

  • The Second Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471099

    Yaliang Yu, 15225590136, 406356708@qq.com

  • Meihekou Central Hospital

    Meihekou, Jilin, 135000

    Rui Wang, 15114379494, wangrui2323@163.com

  • Meishan Cardio Cerebrovascular Disease Hospital

    Meishan, Sichuan, 062000

    Junyan Zeng, 18391807268, 383558826@qq.com

  • People'S Hospital of Tanghe

    Nanyang, Henan, 473400

    Minqiang Qu, 13683909120, 404768751@qq.com

  • Ningde People's Hospital

    Ningde, Fujian, 352100

    Guoping Zou, 13850326351, zoug-ping@163.com

  • The People's Hospital of Nujiang Lisu Autonomous Prefecture

    Nujiang, Yunnan, 673299

    Liqin He, 13988678392, hlq6932@126.com

  • Pingdingshan The second people's hospital

    Pingdingshan, Henan, 467000

    Yankuo Wang, 15637582390, wyk94@126.com

  • The First People's Hospital of Pingdingshan

    Pingdingshan, Henan, 467099

    Hongxu Wang, 13303756971, 42242085@qq.com

  • Ninger People's Hospital

    Pu'er, Yunnan, 665199

    Junyong Zhao, 18108791218, 18108791218@163.com

  • Chinese Medicine Hospital Of Puyang

    Puyang, Henan, 457000

    Ruili Liu, 17698298178, liuliu1982@163.com

  • Puyang Oilfield General Hospital

    Puyang, Henan, 457000

    Yutie Zhao, 13633935069, 3785873340@qq.com

  • Puyang People's Hospital

    Puyang, Henan, 457000

    Jintao Guo, 18639399652, gjt369@126.com

  • Puyang County People's Hospital

    Puyang, Henan, 457161

    Sumin Bai, 18538335396, 309589341@qq.com

  • Nanle People's Hospital

    Puyang, Henan, 457400

    Tingting Zhang, 13503930546, 1024675614@qq.com

  • Qingdao Cardiovascular Hospital Co., Ltd.

    Qingdao, Shandong, 266000

    Shiyao You, 18660298128, 285751500@qq.com

  • Tianjin Cancer Hospital Qinhuangdao Branch

    Qinhuangdao, Hebei, 066002

    Hongmei Zhang, 18133858389, zhmzhongguo@126.com

  • The Second Hospital of Qinhuangdao

    Qinhuangdao, Hebei, 066699

    Guanglei Li, 13613355378, liguanglei123@126.com

  • The Second Affiliated Hospital of Qiqihar Medical University

    Qiqihar, Heilongjiang, 161000

    Hongjiao Wang, 13946267867, aj.wang@163.com

  • Sanmenxia Central Hospital

    Sanmenxia, Henan, 472000

    Shufang Yao, 15138163911, yaoshufang2008@126.com

  • Yellow River Sanmenxia Hospital

    Sanmenxia, Henan, 472000

    Meng Xue, 15039875526, 531897034@qq.com

  • The First People Hospital of Lingbao

    Sanmenxia, Henan, 472599

    Wei Wu, 15839824116, 1034881652@qq.com

  • Liqun Hospital, Putuo District, Shanghai

    Shanghai, Shanghai Municipality, 200333

    Zongyan Dang, 15000988298, dzygsjc@163.com

  • Shanghai Fourth People's Hospital, Affiliated to Tongji University

    Shanghai, Shanghai Municipality, 200434

    Yibin Fang, 13585831041, fangyibin@vip.163.com

  • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 201999

    Jianren Liu, 18616341023, liujr021@sjtu.edu.cn

  • Shang Qiu Hospital of Tcm

    Shangqiu, Henan, 476000

    Zhenggao Chen, 15836819086, 525539124@qq.com

  • People's hospital of NingLing

    Shangqiu, Henan, 476700

    Zhixiang Sui, 13849674499, 2576308695@qq.com

  • Sui county traditional Chinese medicine hospital

    Shangqiu, Henan, 476999

    Ying Li, 13619878828, 1074317027@qq.com

  • Yugan Xinjiang hospital

    Shangrao, Jiangxi, 335100

    Fangqi Tian, 15390771678, tfq_01@163.com

  • Shaoguan Qujiang District People's Hospital

    Shaoguan, Guangdong, 512100

    Cai Zhang, 19866502028, 436028359@qq.com

  • Shaoxing people's hospital

    Shaoxing, Zhejiang, 312000

    Yanxing Zhang, 13867557652, auwxf01@163.com

  • Shenmu Hospital

    Shenmu, Shaanxi, 719300

    Shengli Sun, 13379329868, 729833865@qq.com

  • Northern Theater Command General Hospital

    Shenyang, Liaoning, 110016

    Huisheng Chen, 13149807172, chszh@aliyun.com

  • Central Hospital Affiliated to Shenyang Medical College

    Shenyang, Liaoning, 110024

    Runhui Li, 18002477116, llirh710717@163.com

  • The First People's Hospital Of Shenyang

    Shenyang, Liaoning, 110041

    Li Li, 13840247222, Lily720823@163.com

  • Northern Theater Command Air Force Hospital

    Shenyang, Liaoning, 110042

    Jing Wang, 13322445060, hbf44132@163.com

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning, 110067

    Muhui Lin, 17702485111, lcllmh@126.com

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Junli Zhen, 13831129670, zhenjunli666@163.com

  • Xingtang County People's Hospital

    Shijiazhuang, Hebei, 050699

    Yanxin Wang, 18633876653, bdaczfg@163.com

  • Xinji Traditional Chinese Medicine Hospital

    Shijiazhuang, Hebei, 052360

    Yunsi Cao, 15176953979, ssyycc234@sina.com

  • The Fifth People's Hospital of Ningxia

    Shizuishan, Ningxia, 753000

    Jiqin Yang, 13895329070, 61993234@qq.com

  • The third hospital of shi zui shan

    Shizuishan, Ningxia, 753400

    Juyan Zhang, 18152525995, 791322187@qq.com

  • Hongxinglong Hospital of Beidahuang Group

    Shuangyashan, Heilongjiang, 155811

    Degang Sun, 13329334216, 13329334216@163.com

  • Grand Hospital of Shuozhou

    Shuozhou, Shanxi, 036002

    Guan Wei, 13734210694, 307543402@qq.com

  • Siping City Central People's Hospital

    Siping, Jilin, 136099

    Junfeng Zhao, 13843443119, jlspzjf2727@163.com

  • Suining Center Hospital

    Suining, Sichuan, 629099

    Wenli Xing, 19911866140, 39280847@qq.com

  • Siyang Kangda Hospital

    Suqian, Jiangsu, 223798

    Yanan Zhu, 18936900826, happyzhuyanan@163.com

  • The Second Affiliated Hospital of Shandong First Medical University

    Tai’an, Shandong, 271099

    Haitao Wang, 18553879291, docwht@163.com

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Junhong Guo, 13753127070, neuroguo@163.com

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Zhanjin Deng, 13513639627, 13513639627@163.com

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi, 030024

    Chen Chen, 13934161870, 13934161870@163.com

  • Guye District Hospital of Traditional Chinese Medicine, Tangshan

    Tangshan, Hebei, 063199

    Xiangjun Ji, 15933400014, 469003666@qq.com

  • Yutian County Hospital of Traditional Chinese Medicine

    Tangshan, Hebei, 064199

    Zhiwei Song, 13731528056, szwdeyx@126.com

  • First People's Hospital of Tianshui

    Tianshui, Gansu, 741000

    Guoping Ma, 13919660919, maguopingdr@163.com

  • The First Hospital of Xifeng County

    Tieling, Liaoning, 112400

    Rui Zhang, 13624104199, 6861441@qq.com

  • Tonghua Dongchang District People's Hospital

    Tonghua, Jilin, 134001

    Zhiquan Zhu, 15143596655, 490584871@qq.com

  • Tongliao People's Hospital

    Tongliao, Inner Mongolia, 028000

    Shuyao Wang, 13848555690, 15653292@qq.com

  • Tongren People's Hospital

    Tongren, Guizhou, 554300

    Long Liao, 15121644332, 1992500431@qq.com

  • Xinjiang Production&Construaction Corps Hospital

    Ürümqi, Xinjiang Uygur Autonomous Region, 830002

    Yan Liu, 15292409455, liuyan_333@126.com

  • Weifang People's Hospital

    Weifang, Shandong, 261000

    Li Zhou, 13869621818, weifangzhou003@163.com

  • People's Hospital of Gaomi

    Weifang, Shandong, 261500

    Quanhao Li, 13721968559, liquanhao120@sina.com

  • People's Hospital of Changle County

    Weifang, Shandong, 262400

    Feng Fen, 13573682667, 1013830768@qq.com

  • Weihai Central Hospital

    Weihai, Shandong, 264400

    Xia Zhan, 18306305637, wdzhx686@sina.com

  • Weihai Central Hospital

    Weihai, Shandong, 264400

    Honghao Man, 18306300858, manhonghao1@163.com

  • Weihai Wendeng District People's Hospital

    Weihai, Shandong, 264499

    Jinguo Zhao, 13561852177, zjg52177@163.com

  • Department of Yongjia People's Hospital

    Wenzhou, Zhejiang, 325100

    Han Yu, 13616621974, han21974@126.com

  • Affiliated Yueqing Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325600

    Saizhen Wu, 13757789268, wusaizhen@163.com

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

    Bin Mei, 13037196699, neuromei20@163.com

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241001

    Zhiming Zhou, 13966019211, Neuro_depar@hotmail.com

  • Xi 'an Fengcheng Hospital

    Xi'an, Shaanxi, 710016

    Aimei Wu, 13319207439, 13319207439@163.com

  • The Second Affiliated Hospital of Xi'an Medical University

    Xi'an, Shaanxi, 710038

    Qi Zhou, 15902926849, zhouqi939@163.com

  • Xianning Central Hospital

    Xianning, Hubei, 437000

    Jie Du, 15272730557, 20106452@qq.com

  • Xingtai central hospital

    Xingtai, Hebei, 054000

    Yongmei Kong, 13603193670, xtsykym@126.com

  • Xingtai People's Hospital

    Xingtai, Hebei, 054001

    Xipeng Li, 13932916969, lxp731221@163.com

  • Weixian People's Hospital

    Xingtai, Hebei, 054700

    Zhenlin Wang, 15383196218, sunzhengyishi@126.com

  • Qinghe people's hospital

    Xingtai, Hebei, 054899

    Yingzhuo Zang, 13223268969, wangzang2008@sina.com

  • Qinghai Provincial Traffic Hospital

    Xining, Qinghai, 810000

    Jinlei Zhu, 13997289117, 13997289117@163.com

  • The First Affiliated Hospital of Henan Medical University

    Xinxiang, Henan, 453100

    Jianhua Zhao, 13803800541, 051092@xxmu.edu.cn

  • People's Hospital of Xixian

    Xinyang, Henan, 464399

    Ruiyi Wang, 15137600760, wry15137600760@163.com

  • Changge People's Hospital

    Xuchang, Henan, 461500

    Gexia Liu, 13503899368, m13903992308@163.com

  • Inner Mongolia Forestry General Hospital

    Yakeshi, Inner Mongolia, 022150

    Jing Wang, 13947002639, Wj5667mail@163.com

  • Zichang People's Hospital

    Yan’an, Shaanxi, 717399

    Runting Jing, 13891139790, 250711302@qq.com

  • The First People's Hospital of Yangquan

    Yangquan, Shanxi, 045000

    Jiabin Zhao, 13994470191, 1436660584@qq.com

  • Yantai Hospital of Traditional Chinese Medicine

    Yantai, Shandong, 264000

    Lin Sun, 15953554077, ytzyysl@163.com

  • YEDA hospital

    Yantai, Shandong, 264006

    Haihui Luan, 15264551600, haihuiluan@163.com

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264099

    Zhigang Liang, 13723987720, zgliang@hotmail.com

  • Yantai Taocun Central Hospital

    Yantai, Shandong, 265301

    Zhihua Hao, 13012563066, ythaozhihua@163.com

  • Qixia traditional Chinese medicine hospital

    Yantai, Shandong, 265399

    Xiaoyan Li, 13808915211, 1357612106@qq.com

  • Yantai Penglai traditional Chinese medicine hospital

    Yantai, Shandong, 265699

    Penglai Shi, 18953551266, 452405222@qq.com

  • Jiang'an County Hospital of Traditional Chinese Medicine

    Yibin, Sichuan, 644200

    Xiang Liu, 18408203949, 1027440878@qq.com

  • The Affiliated Hospital of Yongzhou Vocational and Technical College

    Yongzhou, Hunan, 425199

    Jie Yan, 18075812111, arnyyanjie@163.com

  • Zhalantun Hospital of Traditional Chinese and Mongolian Medicine

    Zhalantun, Inner Mongolia, 162650

    Chengyan Yang, 13948903839, y20080608@126.com

  • Zhalantun People's Hospital

    Zhalantun, Inner Mongolia, 162650

    Xiaoyu Qu, 17704705678, quxiaoyu2023@qq.com

  • Xuangang Hospital

    Zhangjiakou, Hebei, 075199

    Lina Qiao, 15031328157, 15031328157@163.com

  • Wuchuan People's Hospital

    Zhanjiang, Guangdong, 524557

    Guanrong Chen, 13543504754, 7161458@qq.com

  • Xingyang People's Hospital

    Zhengzhou, Henan, 450199

    Dongliang Yang, 15639730888, 824025309@qq.com

  • Xinmi Hospital of T.C.M

    Zhengzhou, Henan, 452370

    Jianmin Guo, 13938238698, kingguo0371@163.com

  • Zhoukou Yongshan Hospital

    Zhoukou, Henan, 461300

    Jinqi Fan, 18638083426, 765288157@qq.com

  • Taikang Xian People's Hospital

    Zhoukou, Henan, 461499

    Xinxia Zhao, 15890587206, 15890587206@139.com

  • The First People's Hospital of Zhumadian

    Zhumadian, Henan, 463000

    Xumei Li, 13513865177, 350029688@qq.com

  • Zhumadian Central Hospital

    Zhumadian, Henan, 463000

    Wanchun Li, 15713652696, 15713652696@163.com

  • The People's Hospital of Queshan County

    Zhumadian, Henan, 463200

    Jianxin Xu, 15978828086, 249957242@qq.com

  • The People's Hospital Of Biyang County

    Zhumadian, Henan, 463799

    Shuo Zhang, 17530350999, 84493071@qq.com

Other trials in China

About this study

Official title: A Multicenter, Randomized, Open-label, Parallel-controlled, Event-driven, Blinded-endpoint Trial Evaluating the Efficacy and Safety of Ongericimab Injection in High-risk Stroke Patients With Intracranial or Extracranial Atherosclerotic Stenosis.

The Oris trial aims to evaluate whether the use of Ongericimab injection in patients with atherosclerotic ischemic cerebrovascular disease within 3 months of onset can reduce the risk of recurrent major cardiovascular events by achieving lower lipid-lowering target values (LDL-C < 1.4 mmol/L).

Being tested
High target group, Low target group
Keywords
ischemic stroke, lipid lowering therapy, Ongericimab Injection, LDL-C target
Medical subject headings
Ischemic Stroke

What participants receive

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

  • High target groupCombination product

    Standardized lipid-lowering therapy according to the Chinese Stroke Association Guidelines for Clinical Management of Cerebrovascular Diseases to achieve an LDL-C target below 70 mg/dL (1.8 mmol/L)

  • Low target groupCombination product

    Ongericimab subcutaneous injection once every two weeks (150mg) or every four weeks(300mg) combined with standardized lipid-lowering therapy to achieve an LDL-C target below 55 mg/dL (1.4 mmol/L)

Study groups in NCT07242599
Study groupRoleWhat they receive
Control group (High target group)Active comparatorStandardized lipid-lowering therapy according to the Chinese Stroke Association Guidelines for Clinical Management of Cerebrovascular Diseases to achieve an LDL-C target below 70 mg/dL (1.8 mmol/L).
Receives: Combination Product: High target group
Intervention group (Low target group)ExperimentalOngericimab subcutaneous injection once every two weeks (150mg) or every four weeks(300mg) combined with standardized lipid-lowering therapy to achieve an LDL-C target below 55 mg/dL (1.4 mmol/L)
Receives: Combination Product: Low target group

What is being measured

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

  1. The major cardiovascular events

    The composite primary end point of major cardiovascular events includes ischemic stroke, myocardial infarction, death from cardiovascular causes.

    Measured: A median of 2 years follow-up

Secondary outcomes (7)

  1. New ischemic stroke

    Ischemic stroke refers to acute focal cerebral or retinal infarction, excluding other non-ischemic causes, and meeting any of the following conditions: (1) clinical symptoms or imaging evidence of acute new focal neurological deficit lasting more than 24 hours; or (2) focal symptoms or signs lasting less than 24 hours, but with imaging evidence of new infarction; or (3) progression of pre-existing vascular ischemic stroke (i.e., NIHSS increase of ≥ 4 on the basis of the primary ischemic stroke, excluding hemorrhagic transformation after infarction or symptomatic intracranial hemorrhage) lasting more than 24 hours, with new ischemic changes on head MRI or CT.

    Measured: A median follow-up of 2 years

  2. Myocardial infarction

    Measured: A median of 2 year follow-up

  3. Vascular death

    Measured: A median of 2 years follow-up

  4. Poor functional prognosis (mRS score > 1) at 1 year

    Measured: A median of 2 years follow-up

  5. Severity of new stroke

    Measured: A median of 2 years follow-up

  6. Absolute and percent changes in LDL-C levels

    Measured: A median of 2 years follow-up

  7. Treatment-emergent serious adverse events (SAEs) and adverse events (AEs)

    Treatment-emergent serious adverse events (SAEs) and adverse events (AEs) include cerebral hemorrhage, injection site infections, muscle-related adverse events, new-onset diabetes mellitus, and clinically significant laboratory abnormalities encompassing hepatic/renal function markers, creatine kinase (CK), fasting glucose, and glycated hemoglobin (HbA1c) during the double-blind treatment phase.

    Measured: A median of 2 years follow-up

Timeline

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

  1. First posted21 Nov 2025
  2. Study start22 Apr 2026 (estimated)
  3. Primary completion1 Apr 2029 (estimated)
  4. Study completion1 Apr 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4,810 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07242599
Sponsor's protocol ID
ORIS-2025-10
Acronym
ORIS
Status last verified
Mar 2026
First submitted
17 Nov 2025
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.

    PubMed 21067804

  • Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.

    PubMed 28304224

  • Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H, Lewis BS, Ophuis TO, Jukema JW, De Ferrari GM, Ruzyllo W, De Lucca P, Im K, Bohula EA, Reist C, Wiviott SD, Tershakovec AM, Musliner TA, Braunwald E, Califf RM; IMPROVE-IT Investigators. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015 Jun 18;372(25):2387-97. doi: 10.1056/NEJMoa1410489. Epub 2015 Jun 3.

    PubMed 26039521

  • Turan TN, Nizam A, Lynn MJ, Egan BM, Le NA, Lopes-Virella MF, Hermayer KL, Harrell J, Derdeyn CP, Fiorella D, Janis LS, Lane B, Montgomery J, Chimowitz MI. Relationship between risk factor control and vascular events in the SAMMPRIS trial. Neurology. 2017 Jan 24;88(4):379-385. doi: 10.1212/WNL.0000000000003534. Epub 2016 Dec 21.

    PubMed 28003500

  • Shao C, Zhang S, Cheng Z, Yang K, Wang G, Shi X, Yang H, Ji Y, Li H, Zhang S, Ma J, Pei Z, Zhang Y, Li Y, Li L, Zheng Y, Shao C, Zhang M, Hao Y, Tang YD. Efficacy and safety of ongericimab in Chinese statin-intolerant patients with primary hypercholesterolemia or mixed dyslipidemia: a randomized, placebo-controlled phase 3 trial. Atherosclerosis. 2025 Aug;407:120408. doi: 10.1016/j.atherosclerosis.2025.120408. Epub 2025 Jun 16.

    PubMed 40543299

  • Lin J, Ji Y, Wang G, Ma X, Yao Z, Han X, Chen J, Chen J, Huang W, Xu G, Peng D, Yan P, Qiao P, He Y, Tang Y, Wang M, Zhang M, Yu J, Hao Y, Ma C. Efficacy and safety of ongericimab in Chinese patients with heterozygous familial hypercholesterolemia: A randomized, double-blind, placebo-controlled phase 3 trial. Atherosclerosis. 2025 Apr;403:119120. doi: 10.1016/j.atherosclerosis.2025.119120. Epub 2025 Jan 29.

    PubMed 39999660

  • Xu YY, Chen WQ, Wang MX, Pan YS, Li ZX, Liu LP, Zhao XQ, Wang YL, Li H, Wang YJ, Meng X; CNSR-III Investigators. Lipid management in ischaemic stroke or transient ischaemic attack in China: result from China National Stroke Registry III. BMJ Open. 2023 Mar 8;13(3):e069465. doi: 10.1136/bmjopen-2022-069465.

    PubMed 36889830

  • Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7.

    PubMed 21899409

  • Amarenco P, Bogousslavsky J, Callahan A 3rd, Goldstein LB, Hennerici M, Rudolph AE, Sillesen H, Simunovic L, Szarek M, Welch KM, Zivin JA; Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Investigators. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med. 2006 Aug 10;355(6):549-59. doi: 10.1056/NEJMoa061894.

    PubMed 16899775

  • Amarenco P, Kim JS, Labreuche J, Charles H, Abtan J, Bejot Y, Cabrejo L, Cha JK, Ducrocq G, Giroud M, Guidoux C, Hobeanu C, Kim YJ, Lapergue B, Lavallee PC, Lee BC, Lee KB, Leys D, Mahagne MH, Meseguer E, Nighoghossian N, Pico F, Samson Y, Sibon I, Steg PG, Sung SM, Touboul PJ, Touze E, Varenne O, Vicaut E, Yelles N, Bruckert E; Treat Stroke to Target Investigators. A Comparison of Two LDL Cholesterol Targets after Ischemic Stroke. N Engl J Med. 2020 Jan 2;382(1):9. doi: 10.1056/NEJMoa1910355. Epub 2019 Nov 18.

    PubMed 31738483

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing High target group and Low target group in people with Ischemic Cerebral Infarction, run by Beijing Tiantan Hospital at 199 sites in China.

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 20 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: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 199 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Yongjun Wang, MD (+86 13911172565, yongjunwang111@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The major cardiovascular events (time frame: A median of 2 years follow-up). 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 NCT07242599, which also lists 10 linked publications.

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 16 Apr 2026.

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