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GLICH

Not yet recruitingPhase 2

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

Lead sponsor

Chinese University of Hong Kong

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

200

estimated

Study population

Stroke

Key I/E criterion

—

Primary endpoint

•Edema extension distance on Day 7

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07613437

Org study IDCREC 2026.169

Timeline

Milestones

Study first posted2026-05-29actual

Last update posted2026-05-29actual

Study start2026-06-15estimated

Primary completion2028-06-14estimated

Study completion2028-12-31estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all Semaglutide

Study populations

Who this study enrolls

Stroke

Eligibility

Who can enroll

Minimum age18 Years

Maximum age100 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•1. Primary spontaneous ICH with hematoma location in putamen (10-30mL) or thalamus (5-15mL) on admission CT imaging. Both locations are selected because they are strongly associated with hypertensive arteriopathy-related ICH and there is limited evidence supporting neurosurgical intervention compared with posterior fossa hemorrhages. The thalamic and putaminal volume cutoffs are based on a recent observational study showing that restricting enrolment to 5-15 mL (thalamus) and 10-30 mL (putamen) enriches for patients with substantial but potentially modifiable prognosis while avoiding extremes with ceiling or floor effects. For patients with hematoma involving both putamen and thalamus, a volume cutoff of 5-30mL will be used.

•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

•7. Informed consent obtained from patient (if mentally competent) or legal representative, as per national laws, regulations, and applicable ethics committee requirements

Exclusion criteria

•1. Secondary ICH: ICH due to macrovascular abnormalities (e.g., arteriovenous malformation, aneurysm, arterial dissection, cavernous malformation), coagulopathy, anticoagulant use, antiplatelet overdose, or thrombocytopenia.

•2. ICH involving locations other than putamen or thalamus (e.g., lobar, brainstem, cerebellar, isolated intraventricular hemorrhage). Extension of hematoma into other structures is allowed if the hematoma centroid is within the thalamus or putamen, and the hematoma volume does not exist the respective thresholds as stated in Inclusion Criterion 1.

•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.

•5. Pregnancy, lactation, or positive urine or serum beta human chorionic gonadotropin (β-hCG) test. β-hCG testing should be guided by clinical need.

•6. Creatinine clearance < 30 mL/min (estimated by Cockcroft-Gault equation or measured)

•7. Severe or fatal comorbid illness with life expectancy < 3 years (e.g., terminal malignancy, advanced organ failure)

•8. Participation in another clinical trial investigating a drug, medical device, or medical procedure within 30 days preceding trial inclusion.

•9. Known history of allergy or hypersensitivity to GLP-1RA.

•10. Family or personal history of multiple endocrine neoplasia (MEN), medullary thyroid carcinoma, or pancreatic carcinoma

•11. Active sepsis at time of randomization, defined as a body temperature of ≥ 38.5C, or suspected or documented infection and acute organ dysfunction, operationalized as an increase in SOFA score ≥ 2 points from baseline (baseline assumed 0 if no pre-existing organ dysfunction)

•12. Contraindications to proposed imaging studies (e.g., pacemaker incompatibility with MRI where applicable)

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Cardiovascular outcomes

1 endpoint

Secondary/protocol endpoint

6. Neurological function of participants assessed by National Institute of Health Stroke Scale

Time frame:Day 3, Day 7, Day 14, Day 30, Day 90 and Day 180

descriptive

Other (unclassified)

12 endpoints

Primary/protocol endpoint/low confidence

Edema extension distance on Day 7

Time frame:Day 7

descriptive