Recruiting
Phase 1
Phase 2

Angiotensin (1-7)

Sponsor:

University of Arizona

Code:

NCT06282965

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Angiotensin (1-7)

Sterile saline

Study Details

Brief summary:

The goal of this clinical trial is to test the safety of the drug Angiotensin (1-7) and learn whether it works well as a treatment in people who have suffered a moderate to severe traumatic brain injury (TBI).

The main questions this trial aims to answer are:

  • Is Angiotensin (1-7) safe?
  • Does Angiotensin (1-7) improve mental functioning and reduce physical signs of brain damage in people who have suffered a moderate to severe TBI?

Participants will:

  • Complete 21 days of study treatment consisting of a once-daily injection.
  • Provide blood samples.
  • Undergo two magnetic resonance imaging (MRI) scans of the brain.
  • Complete specific tasks and questionnaires that allow researchers to evaluate the participant's brain and psychological functioning.

Researchers will compare three groups: two groups that receive different doses of Angiotensin (1-7) and one group that receives a look-alike treatment with no active drug. This will allow researchers to see if the drug has any negative effects and whether it improves mental functioning and physical signs of brain damage after a TBI.

Conditions

Traumatic Brain Injury

Study ID

NCT06282965

Start date

May 28, 2024

Status verified date

Jul, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ang 1-7 100 mcg/kg/day

Angiotensin I/II (1-7) acetate will be delivered as a subcutaneous injection at a dose of 100 micrograms per kilogram per day for 21 days.

experimental: Ang 1-7 200 mcg/kg/day

Angiotensin I/II (1-7) acetate will be delivered as a subcutaneous injection at a dose of 200 micrograms per kilogram per day for 21 days.

placebo comparator: Placebo

Sterile saline (NaCl) will be delivered as a subcutaneous injection for 21 days.

Interventions

Angiotensin (1-7)

The drug will be dissolved in 0.9% USP/NF grade sterile for injection saline (NaCl) and prepared in a concentration that aligns with the participant's weight.

Sterile saline

Sterile solution of 0.9% NaCl in water.

Primary outcome measure

  • Number of participants with adverse events [ Time Frame: At 21 days ]
  • Performance on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Clinical Research Coordinator

(520) 237-6845traumaresearch@arizona.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Clinical Research Coordinator

(520) 237-6845traumaresearch@arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

Aug 11, 2026

Last verified

Jul, 2026

Keywords

  • renin angiotensin system
  • cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2026-08-11.