Can a diabetes drug help the brain heal after a stroke?
NCT ID NCT07734792
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial investigates whether tirzepatide, a drug approved for diabetes and obesity, can improve recovery in people who have had a severe stroke caused by a large artery blockage. Participants receive two injections of tirzepatide—one before a clot-removal procedure and another a week later—or standard care alone. The goal is to see if the drug reduces brain injury and helps patients regain independence 90 days after the stroke.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tirzepatide (a drug that activates GLP-1 and GIP pathways, also used for diabetes and obesity)
- What this could lead to
- If it works, tirzepatide could become a new treatment to reduce disability after a severe stroke, helping more people regain independence.
- What could go wrong
- This is an early-to-mid-stage trial, so the drug may not improve recovery and could cause side effects like nausea or low blood sugar. Results may not apply to all stroke patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 430 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 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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19 to 80 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: Participants must meet all of the following criteria: 1. Age \>18 years and ≤80 years; 2. Acute ischemic stroke with imaging-confirmed anterior large vessel occlusion at: * Terminal ICA, * M1 segment of the middle cerebral artery, or * Dominant M2 segment; 3. NIHSS score between 6 and 25 prior to randomization; 4. Alberta Stroke Program Early CT Score (ASPECTS) of 6-10 before randomization; 5. Time from symptom onset (or last known well) to planned endovascular thrombectomy within 24 hours; 6. Pre-stroke mRS score of 0-1; 7. Patients presenting within 6 hours of symptom onset are eligible for direct EVT. Patients presenting between 6 and 24 hours after symptom onset must undergo advanced imaging demonstrating a salvageable perfusion mismatch and meet the DEFUSE-3 criteria: an infarct core volume \<70 mL, a mismatch volume \>15 mL, and a mismatch ratio \>1.8; 8. Written informed consent provided by the participant or a legally authorized representative. Exclusion Criteria: Participants meeting any of the following criteria will be excluded: 1. Posterior-circulation large vessel occlusion stroke; 2. Receipt of intravenous thrombolysis prior to randomization; 3. Simultaneous bilateral anterior-circulation occlusions or concurrent anterior- and posterior-circulation occlusions; 4. Intracranial hemorrhage on baseline CT or MRI, including subarachnoid hemorrhage or intracerebral hemorrhage; evidence of large established infarction, defined as: * ASPECTS \<6, * Ischemic core volume ≥70 mL on CTP, or * Infarction involving \>1/3 of the middle cerebral artery territory; 5. Active bleeding within the previous month (e.g., gastrointestinal, genitourinary, or retinal hemorrhage), major organ surgery or biopsy within 14 days before stroke onset, or known bleeding diathesis; 6. Refractory hypertension despite treatment, defined as persistent systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg; 7. Severe hepatic or renal impairment, including: * Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m², * Serum creatinine \>200 μmol/L, * Child-Pugh Class C or higher liver disease, * Recurrent unexplained hypoglycemia; 8. Blood glucose \<2.7 mmol/L or \>22.2 mmol/L; platelet count \<80 × 10⁹/L; or international normalized ratio (INR) \>1.7; 9. Previous use of GLP-1 receptor agonists or GIP receptor agonists, or known hypersensitivity to these agents; 10. Personal or family history of medullary thyroid carcinoma (MTC) or diagnosis of Multiple Endocrine Neoplasia Type 2 (MEN2); 11. History of severe anxiety or depression prior to stroke onset; 12. Severe underlying disease with life expectancy \<1 year, such as advanced malignancy; 13. Pregnancy or breastfeeding; 14. Participation in another clinical trial.
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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
1 site. 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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The Second Afliated Hospital of SooChow University
Suzhou, Jiangsu, 215004, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stroke treatment upgrade: adding a Clot-Buster after clot removal may boost recovery
- Gene therapy particles aim to boost stroke recovery
- Stroke recovery breakthrough? new study tests simple blood flow trick
- Balloon catheters may improve stroke clot removal
- Blood test may forecast stroke severity
- Could a single shot boost stroke recovery? new trial aims to find out