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Role of GLP1 RA Dulaglutide on Severe Intracranial Atherosclerosis
Plain-language guide to NCT07282041: phase 2, phase 3 randomized trial of Dulaglutide, 130 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07282041
- Phase
- phase 2, phase 3
- Status
- recruiting participants
- Start
- 2025-12-17
- Completion (planned or actual)
- 2030-12-01
- Participants
- 130 (estimated)
- Design
- randomized, single-blind, prevention
- Conditions studied
- Intracranial Atherosclerosis; Stroke, Ischemic
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2, phase 3 trial, researchers set out to test Dulaglutide.
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.
It had two arms (groups): Dulaglutide (experimental) and Standard medical therapy (no intervention).
Study participants would receive standard medical therapy plus Dulaglutide.
Study participants would receive standard medical therapy.
The registry classes the interventions as drug.
More on the Plan
BACKGROUND AND RATIONALE Intracranial large artery atherosclerotic disease (ICAD) is widely prevalent among Asians.
Rationale for the Study Purpose GLP1 receptor agonists (GLP1 RA) beyond glucose lowering Glucagon-like peptide 1 (GLP1) was discovered in 1987.
GLP1 enhances release of insulin in response to ingestion of glucose, known as incretin effect.
The first GLP1 receptor agonist (GLP1 RA) exenatide, was approved in 2005 to treat T2DM.
Who Took Part
130 planned participants were the target.
It was open to people of any sex aged from 21 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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.
The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: cancer diagnosed within past 3 years,; currently being planned for coronary or carotid artery revascularization,; history of previous pancreatitis,.
How the Study Was Run
The set-up was randomized, parallel-group and single-blind.
Because people in this Dulaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Only one side, usually the participants, was kept unaware of whether Dulaglutide was given.
Those kept unaware of assignments: outcomes assessor.
It started in 2025-12-17 with completion listed for 2030-12-01.
It ran at 1 site in Singapore.
Its stated primary purpose is prevention.
What Was Measured
It also tracked 2 secondary outcomes, for example To evaluate the impact of Dulaglutide on recurrence of cerebral ischaemic event within 1 year.
What This Means in Plain Language
Put simply, this is a phase 2, phase 3, randomized trial of Dulaglutide in 130 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Dulaglutide compound page, all human trials.
Our Notes on the Compound
Dulaglutide: A once-weekly GLP-1 receptor agonist (two GLP-1 analog chains joined to an antibody Fc fragment), sold as Trulicity.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.