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New stroke drug LT3001 tested in small trial – could it be safer?

NCT ID NCT04091945

Disease control Sponsor: Lumosa Therapeutics Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase IIa trial tested a single dose of LT3001, a new drug, in 24 people who had an acute ischemic stroke within the past 24 hours. The main goal was to see if the drug causes dangerous bleeding in the brain compared to a placebo. Researchers also looked for early signs that the drug might help improve outcomes. The study is complete, but results are not yet published.

What this could mean

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

Active substance
LT3001
What this could lead to
If successful, this could point toward a new treatment option for acute ischemic stroke that may help restore blood flow with a lower risk of bleeding.
What could go wrong
This is an early Phase IIa trial with only 24 participants, so results may not apply broadly. The main safety concern is bleeding in the brain, and the drug may not prove effective in larger studies.

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

24 people

The number who actually took part.

Started

Jan 2020

Finished

Feb 2021

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 90 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: * 18 to 90 years * NIHSS of 4 to 30 * Diagnosis of AIS within 24 hours after stroke symptoms onset Exclusion Criteria: * Treatement with approved drug during the current AIS * Pre-stroke disability * Imaging evidence of acute intracranial hemorrhage, intraparenchymal tumor, arteriovenous malformations, other central nervous system lesions that could increase bleeding risk, or aneurysm requiring treatment * Suspected subarachnoid hemorrhage * Seizure * Uncontrolled hypertension * INR \>1.7 and/or abnormal aPTT or platelet count \<100,000/mm3 * Blood glucose concentration \<50 mg/dL or \>400 mg/dL * Lactating or pregnant subjects or those planning to become pregnant during the study * Received anticoagulants and/or antiplatelet therapy and glycoprotein IIb/IIIa inhibitors within 48 hours * AIS, myocardial infarction, serious head trauma or major surgery within 90 days * Bleeding event within 21 days * Puncture of noncompressible vessels within 7 days * Severe hepatic, renal, and/or infectious disease

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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

Contacts and locations

Locations

  • Chattanooga Center for Neurologic Research

    Chattanooga, Tennessee, 37403, United States

  • China Medical University Hospital

    Taichung, Taiwan

  • JFK Neuroscience Institute, JFK Medical Center

    Edison, New Jersey, 08837, United States

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Taiwan

  • Linkou Chang Gung Memorial Hospital

    New Taipei City, Taiwan

  • Taichung Veterans General Hospital

    Taichung, Taiwan

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, Taiwan

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • The Ohio State University - Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536, United States

More trials for these conditions

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