Role of GLP1 RA Dulaglutide on Severe Intracranial Atherosclerosis

NCT07282041 · tracked via the Priya Life Science Singapore tracker

Sponsor

National University of Singapore

Phase

Phase 2/3

Started

2025-12-17

Last updated

2025-12-23

Condition(s) studied

Intracranial AtherosclerosisStroke, Ischemic

Investigational drug(s) / intervention(s)

Dulaglutide →

Dulaglutide: Study participants would be randomised (1:1) to receive standard medical therapy or Dulaglutide plus standard medical therapy

Study summary

One important mechanism of action of GLP1 RA is the improvement in endothelial function, which may be evaluated by the assessment of cerebral vasodilatory reserve (CVR) in patients with severe ICAD. The investigators believe that GLP1 RA would be beneficial for patients with severe ICAD and lead to an improvement in cerebral vasodilatory reserve (CVR) in patients with severe and recently symptomatic stenosis of intracranial carotid artery (ICA) or middle cerebral artery (MCA).

In this open label randomised clinical trial, patients with recently symptomatic and severe stenosis of intracranial carotid artery (ICA) or middle cerebral artery (MCA) with impaired cerebral vasodilatory reserve (CVR) will be included. CVR will be measured with transcranial Doppler (TCD) breath holding index and acetazolamide-challenged single photon emission computed tomography (SPECT). Patients meeting the eligibility criteria would be randomised to receive best medical therapy (according to the international guidelines and institutional practices) or Dulaglutide subcutaneous injection (0.75mg and titrating to 1.5mg, if indicated) once a week, in addition to the best medical therapy. CVR will be measured again at the completion of 1 year. MRI of the brain will be repeated to evaluate any new ischaemic brain lesions. All patients would be followed up for two years for cerebral ischaemic events.

The investigators hypothesize that addition of GLP1 RA therapy would lead to a reduction of at least 4 units in CVR on SPECT as compared to best medical therapy.

Eligibility

Sex

ALL

Min age

21 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Adult patients aged 21 - 80 years old inclusive, * Able to provide consent, * Score 3 or less on the Modified Rankin Score (mRS), * Patients with TIA or mild stroke with severe stenosis of intracranial ICA or MCA and impaired CVR within previous 3-months of acute stroke or TIA Exclusion Criteria: * Chronic kidney disease stage 5 (eGFR\<15 mL/min) or on dialysis, * Cancer diagnosed within past 3 years, * Currently being planned for coronary or carotid artery revascularization, * History of previous pancreatitis, * History of medullary thyroid cancer, * Atrial fibrillation, * Any other condition likely to limit protocol compliance (judged by investigator). * For diabetic patients, patients should not be on Sodium-glucose cotransporter 2 (SGLT2) inhibitor or pioglitazone during the duration of the study, unless these drugs can be stopped without affecting participants' medical condition. For those on Dipeptidyl peptidase-4 (DPP IV) inhibitor, this agent will be discontinued if the patient is randomised to the intervention group. * Known allergies to Acetazolamide. * Women who are pregnant or breastfeeding.

Primary outcome measure(s)

To evaluate whether GLP1 RA (Dulaglutide) therapy would improveme cerebral vasodilatory reserve by at least 4 points in patients with severe stenosis of ICA or MCA — within 1 year
To evaluate whether GLP1 RA (Dulaglutide) therapy would lead to an improvement in cerebral vasodilatory reserve (CVR) by at least 4 points in patients with recently symptomatic and severe stenosis of ICA or MCA.

Trial sites (1)

Facility	City	Region	Status
National University Hospital	Singapore	Singapore	Recruiting

On this site

📄 Trulicity (dulaglutide) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07282041 on ClinicalTrials.gov ↗ ← All trials in Singapore