Could a common diabetes drug be the key to better stroke recovery?
NCT ID NCT07613437
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a GLP-1 receptor agonist (a type of diabetes medicine) can reduce brain swelling and improve recovery in people who have had a bleeding stroke. About 200 adults with a specific type of brain bleed will receive either standard care or the drug plus standard care. The goal is to see if the drug limits secondary brain injury and leads to better function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chinese University of Hong Kong
Hong Kong, Hong Kong
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The First Affiliated Hospital of University of Science and Technology China
Hefei, Anhui, China
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The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a web program rebuild memory after brain injury?
- Portable MRI could speed up stroke treatment
- Can a herbal formula match traditional medicine for brain bleeds?
- Can a blood marker tell fever from infection in stroke?
- Can blood markers predict brain injury outcomes?
- Can an ancient herbal pill improve outcomes after a bleeding stroke?