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Trial · Interventional

Not yet recruitingPhase 2/3Registry data

Tirzepatide in Thrombectomy-Treated Acute Ischemic Stroke: A Randomized Trial

Short name TOPAZ

NCTNCT07734792 (opens ClinicalTrials.gov in a new tab)Other idJD-LK2026069-A01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 2/3
Enrollment
726 participants (estimated)
Sponsor
yifang zhu · Other
Design
Randomized · Single masking
Countries
1 country

China

Start
20 Sept 2026 (estimated)
Primary completion
31 May 2028 (estimated)
Completion
31 Jul 2028 (estimated)
First posted
29 Jul 2026
Last update posted
1 Oct 2026
Conditions
Acute Ischemic Stroke (AIS)

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 2/3

    TOPAZ

    NCT07734792

    est. 20 Sept 2026 to est. 31 Jul 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Acute ischemic stroke caused by blockage of a large artery in the brain is one of the leading causes of death and long-term disability worldwide. For patients with this type of stroke, endovascular thrombectomy (EVT), a procedure that removes the blood clot and restores blood flow to the brain, has become the standard treatment. However, even when blood flow is successfully restored, many patients continue to experience disability because of ongoing brain injury caused by inflammation, oxidative stress, and damage to brain cells after the stroke. This study aims to evaluate whether tirzepatide, a medication that activates both glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) pathways, can improve recovery in patients with acute ischemic stroke caused by large vessel occlusion who receive thrombectomy. Tirzepatide is currently approved for the treatment of conditions such as type 2 diabetes and obesity. Previous studies have shown that tirzepatide can improve blood sugar control, reduce body weight, and provide beneficial effects on cardiovascular health. Laboratory studies and early clinical evidence suggest that medications targeting GLP-1 and GIP pathways may also have protective effects on the brain by reducing inflammation, protecting brain cells, improving blood vessel function, and supporting recovery after stroke. In this study, eligible patients with acute ischemic stroke caused by blockage of a major brain artery will be randomly assigned to receive either tirzepatide plus standard stroke care or standard stroke care alone. Participants will receive two subcutaneous injections of tirzepatide: the first dose before the thrombectomy procedure and the second dose 7 days after the procedure. The study will include multiple hospitals and will use independent assessment of outcomes to ensure reliable evaluation of treatment effects. The primary purpose of this study is to determine whether early treatment with tirzepatide can improve functional recovery 90 days after stroke, measured by the patient's ability to perform daily activities and live independently. The study will also evaluate whether tirzepatide is safe in patients with acute ischemic stroke by monitoring adverse events, complications, and other clinical outcomes. The findings from this study may provide important evidence for a new treatment approach to improve recovery after thrombectomy and reduce disability among patients with severe ischemic stroke.

Interventions

  • TirzepatideDrug
  • Standard Medical Care (SMC)Other

Arms2

  • Experimental

    Tirzepatide Intervention Group

    Participants will receive two subcutaneous injections of tirzepatide: the first administered before EVT and the second administered 7 days after EVT, in addition to standard medical care

  • Active comparator

    Control Group

    Participants will receive EVT and standard medical care without tirzepatide.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. The primary efficacy outcome: Proportion of patients achieving an excellent functional outcome

    Time frame · 90 ± 7 days after randomization

    Registry description

    A excellent functional outcome is defined as modified Rankin Scale (mRS) score of 0-1 at 90 days. The Modified Rankin Scale ranges from 0 to 6, where 0 indicates no symptoms, 1 indicates symptoms without significant disability, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe disability, 5 indicates severe disability, and 6 indicates death. Higher scores indicate worse functional outcomes.

  2. The primary safety outcome: All-cause mortality

    Time frame · 90 ± 7 days

    Registry description

    death from any cause within 90 days

Secondary outcomes(3)

  1. The secondary efficacy outcome: Distribution of mRS scores at 90 days after randomization

    Time frame · 90 ± 7 days

    Registry description

    Ordinal Modified Rankin Scale (mRS) analysis. The Modified Rankin Scale ranges from 0 to 6, where 0 indicates no symptoms, 1 indicates symptoms without significant disability, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe disability, 5 indicates severe disability, and 6 indicates death. Higher scores indicate worse functional outcomes.

  2. The secondary efficacy outcome: Proportion of patients achieving an good functional outcome

    Time frame · 90 ± 7 days

    Registry description

    A good functional outcome is defined as an Modified Rankin Scale (mRS) 0-2 at 90 days after randomization.

  3. The secondary safety outcome: Symptomatic intracranial hemorrhage (sICH)

    Time frame · within 48 hours after thrombectomy

    Registry description

    defined by the Heidelberg Bleeding Classification within 48 hours after thrombectomy

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies8

Studies that cite this trial.

Studies with results

6 studies on this page

Indexing hint: Randomized controlled trial · 2025

7 results

Tirzepatide for Obesity Treatment and Diabetes Prevention.

Jastreboff et al. 2025The New England journal of medicinecited by 343

PMID 39536238DOI 10.1056/nejmoa2410819PUB-39536238

Full text at the publisher7 results
Publisher pageSee results (7)

Indexing hint: Observational study · 2025

5 results

Semaglutide and Tirzepatide in Patients With Heart Failure With Preserved Ejection Fraction.

Krüger et al. 2025JAMAcited by 43

PMID 40886075PMC12400167DOI 10.1001/jama.2025.14092PUB-40886075

Rights unknown5 results
Source linkSee results (5)

Indexing hint: Randomized controlled trial · 2025

5 results

Glucagon-like peptide-1 receptor agonist in large vessel occlusion treated by reperfusion therapy-a phase 2 randomized trial.

Wang et al. 2025Nature communicationscited by 3

PMID 41392086PMC12717234DOI 10.1038/s41467-025-66167-zPUB-41392086

CC BY5 results
Download PDFSee results (5)

Indexing hint: Randomized controlled trial · 2023

2 results

Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes.

Lincoff et al. 2023The New England journal of medicinecited by 2,458

PMID 37952131DOI 10.1056/nejmoa2307563PUB-37952131

Rights unknown2 results
Source linkSee results (2)

Indexing hint: Randomized controlled trial · 2022

8 results

A phase 1 multiple-ascending dose study of tirzepatide in Japanese participants with type 2 diabetes.

Furihata et al. 2022Diabetes, obesity & metabolismcited by 49

PMID 34647404PMC9299227DOI 10.1111/dom.14572PUB-34647404

Free to read · publisher termsCC BY-NC-ND8 results
Read at sourceSee results (8)

Indexing hint: Randomized controlled trial · 2021

19 results

Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes.

Frías et al. 2021The New England journal of medicinecited by 1,535

PMID 34170647DOI 10.1056/nejmoa2107519PUB-34170647

Full text at the publisher19 results
Publisher pageSee results (19)

More studies

2 studies on this page

PubMed tag: none · 2025

Tirzepatide mitigates Stroke-Induced Blood-Brain barrier disruption by modulating Claudin-1 and C/EBP-α pathways.

Wang et al. 2025Molecular medicine (Cambridge, Mass.)cited by 4

PMID 40702450PMC12285096DOI 10.1186/s10020-025-01312-4PUB-40702450

CC BY
Download PDF

Indexing hint: Animal study · 2016

The GLP-1 receptor agonists exendin-4 and liraglutide alleviate oxidative stress and cognitive and micturition deficits induced by middle cerebral artery occlusion in diabetic mice.

Li et al. 2016BMC neurosciencecited by 52

PMID 27296974PMC4907076DOI 10.1186/s12868-016-0272-9PUB-27296974

CC BY
Download PDF

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultHolscher C. Novel dual GLP-1/GIP receptor agonists show neuroprotective effects in Alzheimer's and Parkinson's disease models. Neuropharmacology. 2018 Jul 1;136(Pt B):251-259. doi: 10.1016/j.neuropharm.2018.01.040. Epub 2018 Jan 31. PMID 29402504
  • ResultGoldenberg RM, Cheng AYY, Fitzpatrick T, Gilbert JD, Verma S, Hopyan JJ. Benefits of GLP-1 (Glucagon-Like Peptide 1) Receptor Agonists for Stroke Reduction in Type 2 Diabetes: A Call to Action for Neurologists. Stroke. 2022 May;53(5):1813-1822. doi: 10.1161/STROKEAHA.121.038151. Epub 2022 Mar 9. PMID 35259929
  • ResultKopp KO, Glotfelty EJ, Li Y, Greig NH. Glucagon-like peptide-1 (GLP-1) receptor agonists and neuroinflammation: Implications for neurodegenerative disease treatment. Pharmacol Res. 2022 Dec;186:106550. doi: 10.1016/j.phrs.2022.106550. Epub 2022 Nov 11. PMID 36372278
  • ResultWang C, Gu H, Huo X, Yuan B, Li S, Xu J, Jiang Y, Jing J, Yao X, Li Z, Long F, Ma Z, Zhuang X, Xu L, Jin Y, Huang W, Zhang Y, Wen J, Wang A, Pan Y, Ye W, Yu W, Cheng A, Wang M, Dong Q, Xu A, Wang N, Yang Y, Meng X, Liu L, Zhao X, Li H, Miao Z, Li Z, Wang Y; TASTE-2 investigators. Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial. BMJ. 2026 Jan 7;392:e086850. doi: 10.1136/bmj-2025-086850. PMID 41500725
  • ResultAlbers GW, Marks MP, Kemp S, Christensen S, Tsai JP, Ortega-Gutierrez S, McTaggart RA, Torbey MT, Kim-Tenser M, Leslie-Mazwi T, Sarraj A, Kasner SE, Ansari SA, Yeatts SD, Hamilton S, Mlynash M, Heit JJ, Zaharchuk G, Kim S, Carrozzella J, Palesch YY, Demchuk AM, Bammer R, Lavori PW, Broderick JP, Lansberg MG; DEFUSE 3 Investigators. Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. N Engl J Med. 2018 Feb 22;378(8):708-718. doi: 10.1056/NEJMoa1713973. Epub 2018 Jan 24. PMID 29364767
  • ResultNogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11. PMID 29129157
  • ResultGoyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18. PMID 26898852
  • ResultCampbell BC, Mitchell PJ, Kleinig TJ, Dewey HM, Churilov L, Yassi N, Yan B, Dowling RJ, Parsons MW, Oxley TJ, Wu TY, Brooks M, Simpson MA, Miteff F, Levi CR, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Priglinger M, Ang T, Scroop R, Barber PA, McGuinness B, Wijeratne T, Phan TG, Chong W, Chandra RV, Bladin CF, Badve M, Rice H, de Villiers L, Ma H, Desmond PM, Donnan GA, Davis SM; EXTEND-IA Investigators. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015 Mar 12;372(11):1009-18. doi: 10.1056/NEJMoa1414792. Epub 2015 Feb 11. PMID 25671797
  • ResultPowers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30. PMID 31662037
  • ResultWu S, Wu B, Liu M, Chen Z, Wang W, Anderson CS, Sandercock P, Wang Y, Huang Y, Cui L, Pu C, Jia J, Zhang T, Liu X, Zhang S, Xie P, Fan D, Ji X, Wong KL, Wang L; China Stroke Study Collaboration. Stroke in China: advances and challenges in epidemiology, prevention, and management. Lancet Neurol. 2019 Apr;18(4):394-405. doi: 10.1016/S1474-4422(18)30500-3. PMID 30878104
  • ResultWang W, Jiang B, Sun H, Ru X, Sun D, Wang L, Wang L, Jiang Y, Li Y, Wang Y, Chen Z, Wu S, Zhang Y, Wang D, Wang Y, Feigin VL; NESS-China Investigators. Prevalence, Incidence, and Mortality of Stroke in China: Results from a Nationwide Population-Based Survey of 480 687 Adults. Circulation. 2017 Feb 21;135(8):759-771. doi: 10.1161/CIRCULATIONAHA.116.025250. Epub 2017 Jan 4. PMID 28052979

Eligibility

Who could join, as posted.

Sex
All
Age
from 19 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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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