New shot aims to slash stroke risk by crushing cholesterol

NCT ID NCT07242599

Disease control Sponsor: Beijing Tiantan Hospital Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests a new injectable drug, ongericimab, in about 4,800 people who recently had a stroke due to narrowed arteries. The goal is to see if lowering LDL cholesterol more than current standard care can prevent future strokes, heart attacks, or death from heart disease. Participants will receive either standard cholesterol-lowering therapy or ongericimab injections plus standard therapy, aiming for very low LDL targets.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Ongericimab injection
What this could lead to: If successful, this could provide a new treatment option to lower cholesterol more aggressively and reduce the risk of another stroke or heart attack in high-risk patients.
What could go wrong: This is a large Phase 3 trial, but it is still experimental. The drug may not prove more effective than standard therapy, and side effects from the injection or very low cholesterol levels are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 4,810 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cerebral infarction intracranial arteriosclerosis ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ischemic cerebral infarction

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

199 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Affiliated Hospital of Chifeng University

Chifeng, Inner Mongolia, 024000, China
Affiliated Hospital of Hebei University

Baoding, Hebei, 071000, China
Affiliated Yueqing Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325600, China
Baise City People's Hospital

Baise City, Guangxi, 533099, China
Baotou City Central Hospital

Baotou, Inner Mongolia, 014040, China
Bayannur Hospital

Bayan Nur, Inner Mongolia, 015000, China
Beian No.1 People's Hospital

Harbin, Heilongjiang, 164000, China
Beijing Tiantan Hospital, Capital Medical University

Beijing, China
Benxi Central Hospital

Benxi, Liaoning, 117100, China
Binzhou Medical University Hospital

Binzhou, Shandong, 256603, China
Central Hospital Affiliated to Shenyang Medical College

Shenyang, Liaoning, 110024, China
Central Hospital of Dalian University of Technology （Dalian Municipal Central Hospital）

Dalian, Liaoning, 116000, China
Changge People's Hospital

Xuchang, Henan, 461500, China
Changzhi People's Hospital

Changzhi, Shanxi, 046000, China
Chenzhou 3rd People's Hospital

Chenzhou, Hunan, 423000, China
Chenzhou No.1 People's Hospital

Chenzhou, Hunan, 423099, China
Chifeng City Center Hospital Ningcheng County

Chifeng, Inner Mongolia, 024200, China
Chifeng Hospital of Traditional Chinese and Mongolian Medicine

Chifeng, Inner Mongolia, 024005, China
China-Japan Union Hospital of Jilin University

Changchun, Jilin, 130033, China
Chinese Medicine Hospital Of Puyang

Puyang, Henan, 457000, China
Chongqing Sanbo Changan Hospital

Chongqing, Chongqing Municipality, 400023, China
Cixian People's Hospital

Handan, Hebei, 056500, China
DA QING LongNan Hospital

Daqing, Heilongjiang, 163453, China
Dalian Jinzhou District First People's Hospital

Dalian, Liaoning, 116199, China
Dalian University Affiliated Xinhua Hospital

Dalian, Liaoning, 116021, China
Dalian lvshunkou district traditional Chinese medicine hospital

Dalian, Liaoning, 116041, China
Dandong Central Hospital

Dandong, Liaoning, 118000, China
Dandong First Hospital

Dandong, Liaoning, 118000, China
Daqing No.4 hospital

Daqing, Heilongjiang, 163000, China
Daqing Oilfield General Hospital

Daqing, Heilongjiang, 163001, China
Department of Yongjia People's Hospital

Wenzhou, Zhejiang, 325100, China
First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China
First People's Hospital of Tianshui

Tianshui, Gansu, 741000, China
Fuyang People's Hospital

Fuyang, Anhui, 236004, China
Gansu Provincial Maternity and Child-care Hospital(Gansu Provincial Central Hospital)

Lanzhou, Gansu, 730070, China
General Hospital of Benxi Iron

Benxi, Liaoning, 117000, China
Grand Hospital of Shuozhou

Shuozhou, Shanxi, 036002, China
Guye District Hospital of Traditional Chinese Medicine, Tangshan

Tangshan, Hebei, 063199, China
Haiyan People's Hospital

Jiaxing, Zhejiang, 314399, China
HanDan Central Hospital

Handan, Hebei, 057150, China
Hebei Tang County People's Hospital

Baoding, Hebei, 071030, China
Hebi Coal Industry (Group) Co., Ltd. General Hospital

Hebi, Henan, 458031, China
Hejian People's Hospital

Hejian, Hebei, 062450, China
Hengshui People's Hospital

Hengshui, Hebei, 053000, China
Hongxinglong Hospital of Beidahuang Group

Shuangyashan, Heilongjiang, 155811, China
HuZhou Central Hospital

Huzhou, Zhejiang, 313000, China
Huidong People'S Hospital

Huizhou, Guangdong, 516300, China
Huizhou First Hospital

Huizhou, Guangdong, 516003, China
Huludao Central Hospital

Huludao, Liaoning, 125001, China
Inner Mongolia Forestry General Hospital

Yakeshi, Inner Mongolia, 022150, China
Jiang'an County Hospital of Traditional Chinese Medicine

Yibin, Sichuan, 644200, China
Jiaozuo Coal Mining Group Co., Ltd. Central Hospital

Jiaozuo, Henan, 454001, China
Jiujiang No.1 People's Hospital

Jiujiang, Jiangxi, 332000, China
Jiyuan Hospital of Traditional Chinese Medicine

Jiyuan, Henan, 459001, China
Lianshui County People's Hospital

Huai'an, Jiangsu, 223400, China
Lianyuan People's Hospital

Loudi, Hunan, 417100, China
Liaocheng Brain Hospital

Liaocheng, Shandong, 252000, China
Liaocheng City Central Hospital

Liaocheng, Shandong, 252001, China
Liaocheng People's Hospital

Liaocheng, Shandong, 252037, China
Liaoning Health Industry Group Fukuang General Hospital

Fushun, Liaoning, 113008, China
Linfen Central Hospital

Linfen, Shanxi, 041000, China
Liqun Hospital, Putuo District, Shanghai

Shanghai, Shanghai Municipality, 200333, China
Lishui Central Hospital

Lishui, Zhejiang, 323000, China
Liuyang Jili Hospital

Changsha, Hunan, 410399, China
Liuzhou Worker's Hospital

Liuzhou, Guangxi, 545005, China
Luoyang Central Hospital

Luoyang, Henan, 471009, China
Luoyang First People's Hospital

Luoyang, Henan, 471002, China
Meihekou Central Hospital

Meihekou, Jilin, 135000, China
Meishan Cardio Cerebrovascular Disease Hospital

Meishan, Sichuan, 062000, China
Mengzhou Fuxing hospital

Jiaozuo, Henan, 454750, China
Mengzhou Hospital of Traditional Chinese Medicine

Jiaozuo, Henan, 454750, China
Minxian County Hospital of Traditional Chinese Medicine

Dingxi, Gansu, 748400, China
Mudanjiang Hospital of Beidahuang Group

Jixi, Heilongjiang, 158300, China
Nanle People's Hospital

Puyang, Henan, 457400, China
Ningcheng County Hospital of Traditional Chinese and Mongolian Medicine

Chifeng, Inner Mongolia, 024200, China
Ningde People's Hospital

Ningde, Fujian, 352100, China
Ninger People's Hospital

Pu'er, Yunnan, 665199, China
Ningjin People's Hospital

Dezhou, Shandong, 253499, China
No.1 People'S Hospital of Heihe

Heihe, Heilongjiang, 164300, China
Northern Theater Command Air Force Hospital

Shenyang, Liaoning, 110042, China
Northern Theater Command General Hospital

Shenyang, Liaoning, 110016, China
People'S Hospital of Tanghe

Nanyang, Henan, 473400, China
People's Hospital of Changle County

Weifang, Shandong, 262400, China
People's Hospital of Gaomi

Weifang, Shandong, 261500, China
People's Hospital of Qihe County

Dezhou, Shandong, 251100, China
People's Hospital of Xixian

Xinyang, Henan, 464399, China
People's hospital of NingLing

Shangqiu, Henan, 476700, China
Pingdingshan The second people's hospital

Pingdingshan, Henan, 467000, China
Puding County People's Hospital

Anshun, Guizhou, 562100, China
Puyang County People's Hospital

Puyang, Henan, 457161, China
Puyang Oilfield General Hospital

Puyang, Henan, 457000, China
Puyang People's Hospital

Puyang, Henan, 457000, China
Qingdao Cardiovascular Hospital Co., Ltd.

Qingdao, Shandong, 266000, China
Qinghai Provincial Traffic Hospital

Xining, Qinghai, 810000, China
Qinghe people's hospital

Xingtai, Hebei, 054899, China
Qinyang City Hospital of Traditional Chinese Medicine

Jiaozuo, Henan, 454550, China
Qinyang People's Hospital

Jiaozuo, Henan, 454550, China
Qiuxian County People's Hospital

Handan, Hebei, 057450, China
Qixia traditional Chinese medicine hospital

Yantai, Shandong, 265399, China
Qufu People's Hospital

Jining, Shandong, 273100, China
Sanmenxia Central Hospital

Sanmenxia, Henan, 472000, China
Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China
Shang Qiu Hospital of Tcm

Shangqiu, Henan, 476000, China
Shanghai Fourth People's Hospital, Affiliated to Tongji University

Shanghai, Shanghai Municipality, 200434, China
Shanghai General Hospital Jiuquan Hospital

Jiuquan, Gansu, 735008, China
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 201999, China
Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, 030024, China
Shaoguan Qujiang District People's Hospital

Shaoguan, Guangdong, 512100, China
Shaoxing people's hospital

Shaoxing, Zhejiang, 312000, China
Shenmu Hospital

Shenmu, Shaanxi, 719300, China
Sinopharm North Hospital

Baotou, Inner Mongolia, 221116, China
Siping City Central People's Hospital

Siping, Jilin, 136099, China
Siyang Kangda Hospital

Suqian, Jiangsu, 223798, China
Sui county traditional Chinese medicine hospital

Shangqiu, Henan, 476999, China
Suining Center Hospital

Suining, Sichuan, 629099, China
Taikang Xian People's Hospital

Zhoukou, Henan, 461499, China
Taoyuan People'S Hospital

Changde, Hunan, 415700, China
The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China
The Affiliated Hospital of Yongzhou Vocational and Technical College

Yongzhou, Hunan, 425199, China
The Fifth People's Hospital of Chongqing

Chongqing, Chongqing Municipality, 400062, China
The Fifth People's Hospital of Ningxia

Shizuishan, Ningxia, 753000, China
The First Affiliated Hospital of Chongqing Medical and Pharmaceutical College

Chongqing, Chongqing Municipality, 401334, China
The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Henan Medical University

Xinxiang, Henan, 453100, China
The First Affiliated Hospital of Henan Polytechnic University (Jiaozuo Second People's Hospital)

Jiaozuo, Henan, 454001, China
The First Affiliated Hospital of Jiamusi University

Jiamusi, Heilongjiang, 154000, China
The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, 241001, China
The First Hospital of Fangshan District, Beijing

Beijing, Beijing Municipality, 102499, China
The First Hospital of Xifeng County

Tieling, Liaoning, 112400, China
The First People Hospital of Lingbao

Sanmenxia, Henan, 472599, China
The First People's Hospital Of Shenyang

Shenyang, Liaoning, 110041, China
The First People's Hospital of Jingdezhen

Jingdezhen, Jiangxi, 333099, China
The First People's Hospital of Pingdingshan

Pingdingshan, Henan, 467099, China
The First People's Hospital of Yangquan

Yangquan, Shanxi, 045000, China
The First People's Hospital of Yuzhong County

Lanzhou, Gansu, 730100, China
The First People's Hospital of Zhumadian

Zhumadian, Henan, 463000, China
The Hongda Hospital of Jiamusi University

Jiamusi, Heilongjiang, 154000, China
The NO.4 People's Hospital of Hengshui

Hengshui, Hebei, 053000, China
The NO.4 People's Hospital of Hengshui

Hengshui, Hebei, 053000, China
The No.2 Hospital Of Baoding

Baoding, Hebei, 071051, China
The People's Hospital Of Biyang County

Zhumadian, Henan, 463799, China
The People's Hospital of Gaotang

Liaocheng, Shandong, 252899, China
The People's Hospital of Liaoning Province

Shenyang, Liaoning, 110067, China
The People's Hospital of Nujiang Lisu Autonomous Prefecture

Nujiang, Yunnan, 673299, China
The People's Hospital of Queshan County

Zhumadian, Henan, 463200, China
The People's Hospital of the Qiandongnan Miao and Dong Autonomous Prefecture

Kaili, Guizhou, 556099, China
The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570311, China
The Second Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471099, China
The Second Affiliated Hospital of Qiqihar Medical University

Qiqihar, Heilongjiang, 161000, China
The Second Affiliated Hospital of Shandong First Medical University

Tai’an, Shandong, 271099, China
The Second Affiliated Hospital of Xi'an Medical University

Xi'an, Shaanxi, 710038, China
The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China
The Second Hospital of Qinhuangdao

Qinhuangdao, Hebei, 066699, China
The Second People's Hospital of Dongying

Dongying, Shandong, 257335, China
The Third People Hospital in Liaocheng

Liaocheng, Shandong, 252006, China
The first affiliated hospital of Dalian Medical University

Dalian, Liaoning, 116011, China
The people's Hospital of Linqing

Liaocheng, Shandong, 252699, China
The third hospital of shi zui shan

Shizuishan, Ningxia, 753400, China
Tianjin Cancer Hospital Qinhuangdao Branch

Qinhuangdao, Hebei, 066002, China
Tonghua Dongchang District People's Hospital

Tonghua, Jilin, 134001, China
Tongliao People's Hospital

Tongliao, Inner Mongolia, 028000, China
Tongren People's Hospital

Tongren, Guizhou, 554300, China
Tuoketuo County Hospital

Hohhot, Inner Mongolia, 010200, China
Wafangdian Third Hospital Co., Ltd.

Dalian, Liaoning, 116300, China
Weifang People's Hospital

Weifang, Shandong, 261000, China
Weihai Central Hospital

Weihai, Shandong, 264400, China
Weihai Central Hospital

Weihai, Shandong, 264400, China
Weihai Wendeng District People's Hospital

Weihai, Shandong, 264499, China
Weixian People's Hospital

Handan, Hebei, 056800, China
Weixian People's Hospital

Xingtai, Hebei, 054700, China
Wuchuan People's Hospital

Zhanjiang, Guangdong, 524557, China
Wuyuan County People's Hospital

Bayan Nur, Inner Mongolia, 015100, China
Xi 'an Fengcheng Hospital

Xi'an, Shaanxi, 710016, China
Xianning Central Hospital

Xianning, Hubei, 437000, China
Xingtai People's Hospital

Xingtai, Hebei, 054001, China
Xingtai central hospital

Xingtai, Hebei, 054000, China
Xingtang County People's Hospital

Shijiazhuang, Hebei, 050699, China
Xingyang People's Hospital

Zhengzhou, Henan, 450199, China
Xinji Traditional Chinese Medicine Hospital

Shijiazhuang, Hebei, 052360, China
Xinjiang Production&Construaction Corps Hospital

Ürümqi, Xinjiang Uygur Autonomous Region, 830002, China
Xinmi Hospital of T.C.M

Zhengzhou, Henan, 452370, China
Xiuwu County People's Hospital

Jiaozuo, Henan, 454350, China
Xuangang Hospital

Zhangjiakou, Hebei, 075199, China
YEDA hospital

Yantai, Shandong, 264006, China
Yangxin County People's Hospital

Binzhou, Shandong, 251800, China
Yantai Hospital of Traditional Chinese Medicine

Yantai, Shandong, 264000, China
Yantai Penglai traditional Chinese medicine hospital

Yantai, Shandong, 265699, China
Yantai Taocun Central Hospital

Yantai, Shandong, 265301, China
Yantai Yuhuangding Hospital

Yantai, Shandong, 264099, China
Yellow River Sanmenxia Hospital

Sanmenxia, Henan, 472000, China
Yugan Xinjiang hospital

Shangrao, Jiangxi, 335100, China
Yuncheng County People's Hospital

Heze, Shandong, 274799, China
Yutian County Hospital of Traditional Chinese Medicine

Tangshan, Hebei, 064199, China
Zhalantun Hospital of Traditional Chinese and Mongolian Medicine

Zhalantun, Inner Mongolia, 162650, China
Zhalantun People's Hospital

Zhalantun, Inner Mongolia, 162650, China
Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China
Zhoukou Yongshan Hospital

Zhoukou, Henan, 461300, China
Zhumadian Central Hospital

Zhumadian, Henan, 463000, China
Zichang People's Hospital

Yan’an, Shaanxi, 717399, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.