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Clinical Trials in China / NCT07242599
Starting soon Phase 3

Ongericimab Injection Reducing Recurrence of Ischemic Stroke

NCT07242599 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Tiantan Hospital
Phase
Phase 3
Started
2026-04-22
Last updated
2026-04-16

Condition(s) studied

Ischemic Cerebral Infarction

Investigational drug(s) / intervention(s)

High target groupLow target group

High target group: 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 group: 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 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (199)

FacilityCityRegionStatus
Fuyang People's Hospital Fuyang Anhui
The First Affiliated Hospital of Wannan Medical College Wuhu Anhui
The First Hospital of Fangshan District, Beijing Beijing Beijing Municipality
Chongqing Sanbo Changan Hospital Chongqing Chongqing Municipality
The Fifth People's Hospital of Chongqing Chongqing Chongqing Municipality
The First Affiliated Hospital of Chongqing Medical and Pharmaceutical College Chongqing Chongqing Municipality
Ningde People's Hospital Ningde Fujian
Minxian County Hospital of Traditional Chinese Medicine Dingxi Gansu
Shanghai General Hospital Jiuquan Hospital Jiuquan Gansu
Gansu Provincial Maternity and Child-care Hospital(Gansu Provincial Central Hospital) Lanzhou Gansu
The First People's Hospital of Yuzhong County Lanzhou Gansu
First People's Hospital of Tianshui Tianshui Gansu
Huizhou First Hospital Huizhou Guangdong
Huidong People'S Hospital Huizhou Guangdong
Shaoguan Qujiang District People's Hospital Shaoguan Guangdong
Wuchuan People's Hospital Zhanjiang Guangdong
Baise City People's Hospital Baise City Guangxi
Liuzhou Worker's Hospital Liuzhou Guangxi
Puding County People's Hospital Anshun Guizhou
The People's Hospital of the Qiandongnan Miao and Dong Autonomous Prefecture Kaili Guizhou
Tongren People's Hospital Tongren Guizhou
The Second Affiliated Hospital of Hainan Medical University Haikou Hainan
Affiliated Hospital of Hebei University Baoding Hebei
Hebei Tang County People's Hospital Baoding Hebei
The No.2 Hospital Of Baoding Baoding Hebei
Cixian People's Hospital Handan Hebei
Weixian People's Hospital Handan Hebei
HanDan Central Hospital Handan Hebei
Qiuxian County People's Hospital Handan Hebei
Hejian People's Hospital Hejian Hebei
Hengshui People's Hospital Hengshui Hebei
The NO.4 People's Hospital of Hengshui Hengshui Hebei
The NO.4 People's Hospital of Hengshui Hengshui Hebei
Tianjin Cancer Hospital Qinhuangdao Branch Qinhuangdao Hebei
The Second Hospital of Qinhuangdao Qinhuangdao Hebei
The Second Hospital of Hebei Medical University Shijiazhuang Hebei
Xingtang County People's Hospital Shijiazhuang Hebei
Xinji Traditional Chinese Medicine Hospital Shijiazhuang Hebei
Guye District Hospital of Traditional Chinese Medicine, Tangshan Tangshan Hebei
Yutian County Hospital of Traditional Chinese Medicine Tangshan Hebei

+ 159 more sites — see the full list on the official registry below.

More Beijing Tiantan Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07242599 on ClinicalTrials.gov ↗ ← All trials in China