Effects of Semaglutide on Intracranial Blood Flow and Brain-Barrier Permeability in Type-2 Diabetes

What Was Tested

This registered phase 4 trial tested Semaglutide.

A human subjects research study, the primary purpose of which is to assess the EFFECTS OF SEMAGLUTIDE ON INTRACRANIAL BLOOD FLOW AND BLOOD-BRAIN BARRIER PERMEABILITY IN TYPE-2 DIABETES (T2D) through testing of the intervention on patients in a clinical setting.

The study will randomize subjects with diabetes to either semaglutide or matching placebo.

Magnetic resonance images will be primary endpoint measured at baseline and at one year to assess effect of this FDA approved medication.

It had two arms (groups): Placebo (placebo comparator) and Active (active comparator).

Subjects randomized to placebo for 1 year.

Subjects randomized to semaglutide for 1 year.

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 50 planned participants were the target.

It was open to people of any sex aged from 40 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men and women 40-65 years of age. Has not received any investigational drug in the past 6 months. Willing to participate and sign informed consent.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: contraindication to mri or contrast agent; currently treated with glucagon-like peptide-1 receptor antagonist (same drug class as study intervention); unable to perform home-glucose monitoring.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-01-11 with completion listed for 2026-03-31.

It ran at 1 site in United States.

Its stated primary purpose is screening.

What Was Measured

Researchers chose this as the main measure: Intracranial blood flow (IBF) (time frame: Approximately 12 Months). bloodbrain barrier Ktrans (time frame: Approximately 12 Months).

It also tracked 1 secondary outcome, for example Inflammatory markers.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 50 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.