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New stroke drug shows promise in Mid-Stage trial

NCT ID NCT05686642

Disease control Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase II trial tests a drug called LT3001 in 300 people who have had an acute ischemic stroke. Participants receive either a high or low dose of LT3001 or a placebo by IV infusion within 24 hours of their stroke. The study aims to see if the drug is safe and helps improve recovery, measured by disability scores and stroke severity scales.

What this could mean

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

Active substance
LT3001 (a drug given by IV infusion)
What this could lead to
If successful, this could lead to a new treatment option for acute ischemic stroke that improves recovery and reduces disability.
What could go wrong
This is an early Phase II trial with 300 participants, so results may not confirm benefit. The drug could have side effects or fail to improve outcomes compared to placebo.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 300 people

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

Started

Apr 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 80 years

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: 1. Subjects aged between 18 and 80 years at screening; 2. Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment; 3.4 points ≤ NIHSS score ≤ 25 points at randomization; 4.Subjects who are able to receive the investigational drug within 24 hours after the onset of stroke; 5.Female subjects of childbearing potential or male subjects whose sexual partner are women of childbearing potential have no pregnancy plan and voluntarily take effective contraceptive measures during the study period and for 3 months after the last dose; 6.All subjects sign the informed consent form by themselves or their guardians after receiving complete study information. Exclusion Criteria: 1. Subjects have received or plan to receive endovascular treatment and/or intravenous thrombolytic therapy recommended by Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018 during this onset period; 2. Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points; 3. Neurological signs have improved rapidly and spontaneously at screening; 4. Subjects who have used or are using protocol-prohibited medications after the onset; 5. Subjects with pre-stroke disability; 6. Subjects with intracranial hemorrhagic diseases, tumor in brain parenchyma, arteriovenous malformation, aortic arch dissection, other central nervous system lesions that may increase the risk of hemorrhage, or imaging evidence for arterial aneurysm requiring treatment; 7. Massive infarction on imaging; 8. Patients who are unable to cooperate due to epileptic seizure at the onset of stroke or other concomitant mental disorders or are unwilling to cooperate; 9. Systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg after active antihypertensive therapy; 10. Acute hemorrhage tendency; 11. Blood glucose level \< 50 mg/dL or \> 400 mg/dL; 12. Active visceral hemorrhage; 13. Lactating or pregnant subjects, or women of childbearing potential with positive pregnancy test results; 14. International normalized ratio \> 1.7 or prothrombin time \> 15 s; 15. Subjects with a history of serious hypersensitivity; 16. Subjects who experienced AIS, ICH, acute myocardial infarction or serious head trauma before screening; 17. Subjects who underwent any major surgery before screening; 18. Subjects with a history of active digestive ulcer before screening; 19. Subjects who experienced hemorrhagic disease before screening; 20. Subjects who underwent arterial puncture at the site not easy for hemostasis by compression before screening; 21. Serious hepatic impairment or serious renal insufficiency; 22. Subjects who have participated in another investigational study and used investigational product before screening; 23. Other conditions unsuitable for participation in this study determined by the Investigator.

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

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

Acute ischemic stroke

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    28 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Beijing Luhe Hospital Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 101199, China

    Contact Email: •••••@•••••

  • Beijing Tiantan Hospital, Capital Medical University

    RECRUITING

    Beijing, 100070, China

  • Beijing Tsinghua Changgung Hospital

    RECRUITING

    Beijing, 102218, China

  • Beipiao Central Hospital

    RECRUITING

    Chaoyang, Liaoning, 122199, China

  • Central People's Hospital of Zhanjiang

    RECRUITING

    Zhanjiang, China

  • Daqing Oilfield General Hospital

    RECRUITING

    Daqing, Heilongjiang, 163001, China

  • Harrison International Peace Hospital

    RECRUITING

    Hengshui, Hebei, 053099, China

  • Huai'an Second People's Hospital

    RECRUITING

    Huai'an, Jiangsu, 223022, China

  • Inner Mongolia Baogang Hospital

    RECRUITING

    Baotou, Inner Mongolia, 750306, China

  • Liaocheng People's Hospital

    RECRUITING

    Liaocheng, Shandong, 252004, China

  • Linfen Central Hospital

    RECRUITING

    Linfen, China

  • Linfen People's Hospital

    RECRUITING

    Linfen, China

  • Luoyang Third People's Hospital

    RECRUITING

    Luoyang, He'nan, 471002, China

  • Nanshi Hospital of Nanyang

    RECRUITING

    Nanyang, China

  • Pingxiang People's Hospital

    RECRUITING

    Pingxiang, Jiangxi, 337000, China

  • Shanghai Pudong Hospital

    RECRUITING

    Shanghai, 201399, China

  • Taizhou First People's Hospital

    RECRUITING

    Taizhou, Zhejiang, 318020, China

  • Taizhou Municipal Hospital

    RECRUITING

    Taizhou, Zhejiang, 318000, China

  • The Affiliated Hospital of Xuzhou Medical University

    RECRUITING

    Xuzhou, Jiangsu, 221000, China

  • The First Affiliated Hospital of Baotou Medical College

    RECRUITING

    Baotou, Inner Mongolia, 014017, China

  • The First Affiliated Hospital of Jinan University

    RECRUITING

    Guangzhou, Guangdong, 510630, China

  • The First Bethune Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130061, China

  • The Second Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215004, China

  • The Third Hospital of Mianyang

    RECRUITING

    Mianyang, Sichuan, China

  • Xi'an Gaoxin Hospital

    RECRUITING

    Xi’an, Shanxi, 710077, China

  • Yan'an University Xianyang Hospital

    RECRUITING

    Xianyang, Shanxi, 716099, China

  • Zhejiang Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310013, China

  • Zhongnan Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, 430071, China

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