Efficacy of Semaglutide in Improving Neurological Outcomes After Endovascular Thrombectomy for Acute Ischemic Stroke: A Randomized Double-Blind Controlled Trial

NCT07030621 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2025-175
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 1

Brief Summary

The trial will be a randomized, double-blind, controlled, single-center trial. The purpose of this trial is to determine the efficacy and safety of semaglutide in improving neurological outcomes after endovascular thrombectomy for acute ischemic stroke. The patients in the treatment group will receive a subcutaneous injection of 0.5 mg semaglutide into the abdomen during endovascular thrombectomy. The patients in the control group will receive a similar-looking placebo. Patients will be randomized to the treatment or control group by the pharmacy, eliminating the selection bias. The patient and evaluator will be blind to the allocation of patients, further minimizing the bias.

Conditions

Acute Ischemic Stroke

Keywords

endovascular thrombectomy; semaglutide

Outcome Measures

Primary Outcomes (1)

• mRS at 90-days

  The primary endpoint is the degree of disability or dependence at 90 days as assessed by the mRS shift. A global measure of disability, the mRS comprises of seven grades ranging from 0 (no symptoms) to 6 (death). 0-2 points: indicating good neurological function recovery in patients; 3-6 points: indicating poor neurological function recovery in patients.

  90 days postoperatively

Secondary Outcomes (3)

• National Institute of Health Stroke Scale (NIHSS) at 24 hours and 7-days

  A decrease of ≥8 points in the NIHSS score from baseline to 24 hours and 7 days postoperatively, or a score of 0 to 1, indicates neurological improvement; an increase of ≥4 points indicates neurological deterioration.

• Infarct volume after 72 hours of treatment

  72 hours postoperatively

• the incidence of surgical complications within 90 days postoperatively

  within 90 days postoperatively

Study Arms (2)

semaglutide group

EXPERIMENTAL

The patients will receive a subcutaneous injection of 0.5 mg semaglutide into the abdomen during endovascular thrombectomy

Drug: Semaglutide 0.5 mg

placebo group

PLACEBO COMPARATOR

The patients in the control group will receive a similar-looking Normal Saline

Drug: Normal Saline

Interventions

Semaglutide 0.5 mg DRUG

Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) analog, which has been found to have neuroprotective effects.

semaglutide group

Normal Saline DRUG

Normal saline is the placebo drug.

placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical or imaging diagnosis of acute ischemic stroke within 24 hours after onset;
• Scheduled for endovascular thrombectomy;
• Age ≥18 years;
• Pre-stroke modified Rankin Scale (mRS) score ≤1;
• Informed consent voluntarily signed by the patient or legal representative.

You may not qualify if:

• Preoperative imaging diagnosis of intracranial hemorrhage, or history of intracranial hemorrhage within 3 months prior to surgery;
• Contraindications for endovascular thrombectomy;
• Recent history of ischemic stroke;
• Fasting blood glucose \<3.9 mmol/L;
• ASA classification of IV-V;
• Severe organic heart disease or severe arrhythmia;
• Pregnant or lactating women;
• Contraindications to semaglutide or allergy to semaglutide.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (12)

• Garcia-Casares N, Gonzalez-Gonzalez G, de la Cruz-Cosme C, Garzon-Maldonado FJ, de Rojas-Leal C, Ariza MJ, Narvaez M, Barbancho MA, Garcia-Arnes JA, Tinahones FJ. Effects of GLP-1 receptor agonists on neurological complications of diabetes. Rev Endocr Metab Disord. 2023 Aug;24(4):655-672. doi: 10.1007/s11154-023-09807-3. Epub 2023 May 26.

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• Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15.

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• Cui QN, Stein LM, Fortin SM, Hayes MR. The role of glia in the physiology and pharmacology of glucagon-like peptide-1: implications for obesity, diabetes, neurodegeneration and glaucoma. Br J Pharmacol. 2022 Feb;179(4):715-726. doi: 10.1111/bph.15683. Epub 2021 Nov 23.

  PMID: 34519040 BACKGROUND

• Li Y, Fan Q, Pang R, Cai L, Qi J, Chen W, Zhang Y, Chen C, Yu W, Li P. Semaglultide targets Spp1+ microglia/macrophage to attenuate neuroinflammation following perioperative stroke. J Neuroinflammation. 2025 May 27;22(1):143. doi: 10.1186/s12974-025-03465-9.

  PMID: 40426210 BACKGROUND

• Candelario-Jalil E, Dijkhuizen RM, Magnus T. Neuroinflammation, Stroke, Blood-Brain Barrier Dysfunction, and Imaging Modalities. Stroke. 2022 May;53(5):1473-1486. doi: 10.1161/STROKEAHA.122.036946. Epub 2022 Apr 7.

  PMID: 35387495 BACKGROUND

• DeLong JH, Ohashi SN, O'Connor KC, Sansing LH. Inflammatory Responses After Ischemic Stroke. Semin Immunopathol. 2022 Sep;44(5):625-648. doi: 10.1007/s00281-022-00943-7. Epub 2022 Jun 29.

  PMID: 35767089 BACKGROUND

• Nie X, Leng X, Miao Z, Fisher M, Liu L. Clinically Ineffective Reperfusion After Endovascular Therapy in Acute Ischemic Stroke. Stroke. 2023 Mar;54(3):873-881. doi: 10.1161/STROKEAHA.122.038466. Epub 2022 Dec 7.

  PMID: 36475464 BACKGROUND

• Yoshimura S, Sakai N, Yamagami H, Uchida K, Beppu M, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Takeuchi M, Yazawa Y, Kimura N, Shigeta K, Imamura H, Suzuki I, Enomoto Y, Tokunaga S, Morita K, Sakakibara F, Kinjo N, Saito T, Ishikura R, Inoue M, Morimoto T. Endovascular Therapy for Acute Stroke with a Large Ischemic Region. N Engl J Med. 2022 Apr 7;386(14):1303-1313. doi: 10.1056/NEJMoa2118191. Epub 2022 Feb 9.

  PMID: 35138767 BACKGROUND

• Lansberg MG, Schrooten M, Bluhmki E, Thijs VN, Saver JL. Treatment time-specific number needed to treat estimates for tissue plasminogen activator therapy in acute stroke based on shifts over the entire range of the modified Rankin Scale. Stroke. 2009 Jun;40(6):2079-84. doi: 10.1161/STROKEAHA.108.540708. Epub 2009 Apr 16.

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  PMID: 32668115 BACKGROUND

• Powers 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.

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• GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.

  PMID: 34487721 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

semaglutide; Saline Solution

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Peiying Li MD，Ph.D

CONTACT

+8615800616866; peiyingli.md@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)