GLP-1 Receptor Agonist in Primary Intracerebral Hemorrhage: A Phase 2 Randomized Trial

What Was Tested

The trial (phase 2) is built around Semaglutide.

Intracerebral hemorrhage (ICH) is a devastating form of acute stroke with poor clinical outcomes.

It had two arms (groups): Semaglutide Group (active comparator) and Standard of care (no intervention).

Patients randomized into the semaglutide group will receive subcutaneous injections of semaglutide on baseline (D0), Day 7 (D7), Day 14 (D14) and Day 21 (D21) after enrollment.

The registry classes the interventions as drug.

More on the Plan

Participants will be randomized in a 1:1 ratio to receive additional semaglutide or just standard therapy after a written informed consent.

Patients in the semaglutide group will receive subcutaneous injections of semaglutide on baseline (D0), Day 7 (D7), Day 14 (D14) and Day 21 (D21) after enrollment.

Serial imaging with non-contrast computed tomography (CT) will be performed at baseline, 3+/-1 days, and 7+/-1 days post-enrollment to assess hematoma volume, hematoma expansion, and perihematomal edema (PHE).

Brain magnetic resonance imaging (MRI) will be arranged on Day 5-9 (D30) post-ICH to assess the degree of neuronal injury.

Who Took Part

The registry lists 200 planned participants were the target.

It was open to people of any sex aged from 18 years up to 100 years.

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

Examples of who could join: 2\. National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 AND ≤ 25 at presentation. 3\. Glasgow Coma Scale (GCS) score ≥ 10. 4\. Last-known-well (LKW) to presentation time ≤ 24 hours. 5\. Pre-stroke modified Rankin Scale (mRS) ≤ 2. 6\. Patients deemed not suitable for acute neurosurgical intervention at the time of randomization.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: 1\. secondary ich: ich due to macrovascular abnormalities (e.g., arteriovenous malformation, aneurysm, arterial dissection, cavernous malformation), coagulopathy, anticoagulant use, antiplatelet overdose, or thrombocytopenia; 3\. ich with planned neurosurgical procedure prior to randomization, including hematoma evacuation, external ventricular drainage and decompressive craniectomy; 4\. estimated or known body mass index (bmi) \< 18 kg/m².

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-06-15 with completion listed for 2028-06-14.

It ran at 3 sites in China (2) and Hong Kong (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Edema extension distance on Day 7 (time frame: Day 7).

It also tracked 9 secondary outcomes, for example Proportion of patients with excellent functional outcome (mRS 0-1), Proportion of patients with functional independence (mRS 0-2), Proportion of patients with ambulatory independence (mRS 0-3), Ordinal shift of modified Rankin Scale, 6. Neurological function of participants assessed by National Institute of Health Stroke Scale and Hematoma expansion.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 200 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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