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Can a natural protein fragment help the brain heal after severe injury?

NCT ID NCT06282965

Disease control Sponsor: University of Arizona 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial tests whether Angiotensin (1-7), a synthetic version of a natural protein fragment, is safe and effective for people with moderate to severe traumatic brain injury (TBI). Participants receive a daily injection for 21 days, along with blood tests, MRI scans, and cognitive assessments. Researchers compare two different doses of the drug against a placebo to see if it improves mental functioning and reduces physical signs of brain damage.

What this could mean

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

Active substance
Angiotensin (1-7), a synthetic version of a natural protein fragment, given as a daily injection
What this could lead to
If it works, this could point toward a new treatment to help people recover mental function and reduce brain damage after a traumatic brain injury.
What could go wrong
This is an early-stage trial with a small number of participants, so results may not apply broadly. The drug's safety and effectiveness are still unproven, and it may not improve outcomes.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 90 people

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

Started

May 2024

Expected to finish

Sep 2027

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: * Participant or representative willing to provide informed consent. * Age 18 years or older at time of enrollment. * Traumatically induced head injury resulting from insult to head from an external force. * Clinical diagnosis of acute intracranial lesion based on neuroradiologist report. CT scan and report must be available. * Moderate or severe traumatic brain injury (TBI) defined as Glasgow Coma Scale (GCS) score on trauma presentation of 12 or less. In general: Moderate TBI will be defined as loss of consciousness between 30 minutes and 24 hours and GCS between 9 and 12. Severe TBI will be defined as loss of consciousness \> 24 hours and GCS ≤ 9. * Enrollment within 48 hours of TBI. Exclusion Criteria: * Time of injury cannot be determined. * Neurosurgery within the last 30 days. * History of neurodegenerative disease or disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors that would impact cognitive testing. * Contraindication to having an MRI. * Pregnant or lactating female. * Female of childbearing potential or sexually active male who is not willing to use an acceptable method of birth control for the treatment period and 7 days after the last dose of the study drug. * Participation in another clinical study involving investigational product within 30 days prior to study enrollment. * If in the opinion of the investigator, candidate is unsuitable for participation in the study.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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

Traumatic brain injury

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • University of Arizona

    RECRUITING

    Tucson, Arizona, 85724, United States

More trials for these conditions

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