NCT07282041 Role of GLP1 RA Dulaglutide on Severe Intracranial Atherosclerosis
| NCT ID | NCT07282041 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | National University of Singapore |
| Condition | Intracranial Atherosclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2025-12-17 |
| Primary Completion | 2030-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 130 participants in total. It began in 2025-12-17 with a primary completion date of 2030-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
vijay K sharma, MD
PRINCIPAL INVESTIGATOR
National University of Singapore
Frequently Asked Questions
Who can join the NCT07282041 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Intracranial Atherosclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07282041 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07282041 currently recruiting?
Yes, NCT07282041 is actively recruiting participants. Contact the research team at mdcvks@nus.edu.sg for enrollment information.
Where is the NCT07282041 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT07282041 clinical trial?
NCT07282041 is sponsored by National University of Singapore. The principal investigator is vijay K sharma, MD at National University of Singapore. The trial plans to enroll 130 participants.