Acute Subcutaneous SemaglutidE in Acute Ischemic sTroke

What Was Tested

This registered phase 2 trial tested Semaglutide.

It had two arms (groups): one (active comparator) and Control (other).

Standard care.

The registry classes the interventions as drug and other.

More on the Plan

For detailed project description, please refer to the full trial information at the Clinical Trials Information System (see 'More information' below for link).

Who Took Part

380 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Male and female patients (≥ 18 years) at the time of signed informed consent/proxy consent. Acute ischemic stroke with disabling neurological deficits (defined as an impairment of one or more of the following: language, motor function, cognition, gaze, vision, neglect, or ataxia). Onset/last seen well to randomization \< 4.5 hours. None to moderate disability in daily living before symptom onset (pre-stroke modified Rankin Scale 0-3).

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: BMI\< 22; history of pancreatitis, medullary thyroid carcinoma; predisposition or known multiple endocrine neoplasia syndrome type 2 (men 2).

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

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

Only one side, usually the participants, was kept unaware of whether Semaglutide was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2023-04-12 with completion listed for 2025-09.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Modified Ranking Scale (time frame: 90 (+/- 14) days).

It also tracked 16 secondary outcomes, for example Serious Adverse Events and/or Serious Unexpected Serious Adverse Events, 90-day mortality, One-year mortality, Predefined SAEs, Excellent functional outcome at 90 days and MACCE and recurrent ischemic events, 90 days.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 380 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.