Ischemic StrokeLAMPNCT03948347
Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus
A study testing Liraglutide in people with Ischemic Stroke and Transient Ischemic Attack, run by First Affiliated Hospital of Jinan University at 1 site in China.
Trial summary
The purpose of this study is to assess the safety and efficacy of glucagon-like peptide-1 (GLP-1) analogue liraglutide in the treatment of acute minor stroke (National Institute of Health stroke scale, NIHSS ≤ 3) or high-risk transient ischemic attack (TIA) (ABCD2 score ≥ 4 ) patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack, Type 2 Diabetes Mellitus
- What is being tested?
- Liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,708 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2019to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects (male or female ≥ 50 years);
- Acute ischemic stroke patients (NIHSS ≤ 3 at the time of randomization) with type 2 diabetes mellitus within 24 hours of symptoms onset;
- High-risk TIA patients (ABCD2 score ≥ 4 at the time of randomization) with type 2 diabetes mellitus within 24 hours of onset;
- First stroke, or prior stroke without sequel (mRS score ≤ 1) and does not affect the NIHSS score;
- Informed consent signed.
Who cannot join
- Diagnosis of hemorrhage brain disease on baseline head CT;
- Iatrogenic and cardiogenic stroke;
- Patients receiving thrombolysis or endovascular treatment;
- Use of a GLP-1 analogue or any dipeptidyl peptidase-IV (DPP-IV) inhibitor within the 3 months prior to screening;
- Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC);
- Patients with pancreatitis or previous history of pancreatitis, inflammatory bowel disease and gastroparesis;
Show all 13Show fewer
- Pregnant, lactating women,or patients who are likely to have a pregnancy and plan to have one;
- Allergic to liraglutide or excipients;
- Congestive heart failure (NYHA class III-IV);
- Severe liver and kidney dysfunction (AST/ALT is 3 times higher than the normal upper limit, serum creatinine is 3 times higher than the normal upper limit);
- Patients with malignant tumors who are expected to have a survival period of less than three months;
- Participated in other clinical trials of drugs within 3 months;
- Researchers believe that patients who are not suitable for this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong
Anding Xu, M.D, Ph.D, +86 013392692160, tlil@jnu.edu.cn
Huili Zhu, M.D, +86 013922165588, zhlffff@163.com
About this study
Official title: Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus: A Prospective, Multicenter, Randomized, Blank-controlled，Blinded End-point Study.
The purpose of this study is to assess the safety and efficacy of glucagon-like peptide-1 (GLP-1) analogue liraglutide in the treatment of acute minor stroke (National Institute of Health stroke scale, NIHSS ≤ 3) or high-risk transient ischemic attack (TIA) (ABCD2 score ≥ 4 ) patients with type 2 diabetes mellitus.
Read the detailed description
The treatment arm will receive the starting dose of liraglutide of 0.6mg/d subcutaneously once daily, and the dose will be increased to 1.8mg/d in two weeks, and then continue to administrate this dose for 90 days. The control arm will not use liraglutide. Other types of GLP-1 analogues or degraded by dipeptidyl peptidase-IV (DPP-IV) inhibitors will be prohibited. Study visits will be performed at day 7, day 30±3 and at 90±7 day.
- Being tested
- Liraglutide
- Keywords
- ischemic stroke, transient ischemic attack, glucagon-like peptide-1, type 2 diabetes mellitus
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
The treatment arm will receive the starting dose of liraglutide of 0.6 mg/d subcutaneously once daily, and the dose will be increased to 1.8 mg/d in two weeks, and then continue to administrate this dose for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| active | Active comparator | Active patients will receive liraglutide injections Receives: Drug: Liraglutide |
| standard care/no intervention | No intervention | standard care for stroke as per hospital protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with the 90-day new stroke events (ischemic or hemorrhagic)
Definition of ischemic stroke: An episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction. Either of the following is considered to be an ischemic stroke: a new focal neurologic deficit lasting for less than 24 hours and not attributable to a nonischemic cause but accompanied by neuroimaging evidence of new brain infarction; sudden onset of a new focal neurologic deficit, with clinical or imaging evidence of infarction lasting 24 hours or more and not attributable to a nonischemic cause.
Definition of hemorrhagic stroke: Rapidly developing clinical signs of neurological dysfunction attributable to a focal collection of blood within the brain parenchyma, ventricular system or subarachnoid space that is not caused by trauma.
Measured: 90 days
Secondary outcomes (2)
Percentage of patients with the 90-day new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
Transient ischemic attack was defined as transient neurological deficits caused by focal brain or retinal ischemia, the clinical symptoms are generally no more than 1 hour, and the longest duration is less than 24 hours, and there is no evidence of a responsible lesion.
The clinical definition of myocardial infarction denotes the presence of acute myocardial injury detected by abnormal cardiac biomarkers in the setting of evidence of acute myocardial ischemia.
Vascular death was defined as death due to stroke (ischemic or hemorrhagic), systemic hemorrhage, myocardial infarction, congestive heart failure, pulmonary embolism, sudden death, or arrhythmia.
Measured: 90 days
Percentage of patients with the 90-day Modified Rankin Scale (mRS) ≤ 2
The modified Rankin scale is used to measure the recovery of neurological function in patients after stroke. The following questionnaire will be used to determine the mRs score:
The modified Rankin scale is used to measure the recovery of neurological function in patients after stroke. The following questionnaire will be used to determine the mRs score:
0- No symptoms at all.
- No significant disability despite symptoms; able to carry out all usual duties and activities.
- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.
- Moderate disability; requiring some help, but able to walk without assistance.
- Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance.
- Severe disability, bedridden, incontinent and require constant nursing care and attention.
- Dead.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start25 Jun 2019
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,708 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Jinan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anding Xu, First Affiliated Hospital of Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948347
- Sponsor's protocol ID
- LAMP20190508
- Acronym
- LAMP
- Status last verified
- Feb 2023
- First submitted
- 10 May 2019
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu L, Yang B, Wang Y, Zhu C, Liu Z, Li F, Yang S, Liu Y, Yang Y, Liu X, Huang L, Xu A, Zhu H. Liraglutide and Recurrent Stroke by Baseline Insulin Resistance: A Post Hoc Analysis of the LAMP Trial. Stroke. 2026 Jul;57(7):1960-1970. doi: 10.1161/STROKEAHA.125.056010. Epub 2026 May 18.
PubMed 42145088Zhu H, Yang B, Lu L, Li Y, Sui R, Liu K, Tan S, Wang L, Qiu J, Zhong J, Wei T, Bei Y, Huang J, Zhang S, Ji Y, Wu W, Li Y, Huang Y, Chen Y, Huang X, Zeng G, Zhang Y, Huang L, Li H, Wang X, Wang Y, Xu A; LAMP Investigators. Liraglutide in Acute Minor Ischemic Stroke or High-Risk Transient Ischemic Attack With Type 2 Diabetes: The LAMP Randomized Clinical Trial. JAMA Intern Med. 2026 Jan 1;186(1):46-54. doi: 10.1001/jamainternmed.2025.5684.
PubMed 41182740
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus: A Prospective, Multicenter, Randomized, Blank-controlled，Blinded End-point Study.
- ClinicalTrials.gov ID
- NCT03948347
- Acronym / sponsor ID
- LAMP / LAMP20190508
- Keywords
- ischemic stroke, transient ischemic attack, glucagon-like peptide-1, type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,708 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Jinan UniversityUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and efficacy of glucagon-like peptide-1 (GLP-1) analogue liraglutide in the treatment of acute minor stroke (National Institute of Health stroke scale, NIHSS ≤ 3) or high-risk transient ischemic attack (TIA) (ABCD2 score ≥ 4 ) patients with type 2 diabetes mellitus.
Detailed description
The treatment arm will receive the starting dose of liraglutide of 0.6mg/d subcutaneously once daily, and the dose will be increased to 1.8mg/d in two weeks, and then continue to administrate this dose for 90 days. The control arm will not use liraglutide. Other types of GLP-1 analogues or degraded by dipeptidyl peptidase-IV (DPP-IV) inhibitors will be prohibited. Study visits will be performed at day 7, day 30±3 and at 90±7 day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active | Active comparator | Drug: LiraglutideActive patients will receive liraglutide injections |
| standard care/no intervention | No intervention | –standard care for stroke as per hospital protocol |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subjects (male or female ≥ 50 years);
- Acute ischemic stroke patients (NIHSS ≤ 3 at the time of randomization) with type 2 diabetes mellitus within 24 hours of symptoms onset;
- High-risk TIA patients (ABCD2 score ≥ 4 at the time of randomization) with type 2 diabetes mellitus within 24 hours of onset;
- First stroke, or prior stroke without sequel (mRS score ≤ 1) and does not affect the NIHSS score;
- Informed consent signed.
Key exclusion criteria (13 listed)
- Diagnosis of hemorrhage brain disease on baseline head CT;
- Iatrogenic and cardiogenic stroke;
- Patients receiving thrombolysis or endovascular treatment;
- Use of a GLP-1 analogue or any dipeptidyl peptidase-IV (DPP-IV) inhibitor within the 3 months prior to screening;
- Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideAlso: VictozaThe treatment arm will receive the starting dose of liraglutide of 0.6 mg/d subcutaneously once daily, and the dose will be increased to 1.8 mg/d in two weeks, and then continue to administrate this dose for 90 days. | Drug | active |
Primary outcome
Percentage of patients with the 90-day new stroke events (ischemic or hemorrhagic)
Time frame: 90 days
Definition of ischemic stroke: An episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction. Either of the following is considered to be an ischemic stroke: a new focal neurologic deficit lasting for less than 24 hours and not attributable to a nonischemic cause but accompanied by neuroimaging evidence of new brain infarction; sudden onset of a new focal neurologic deficit, with clinical or imaging evidence of infarction lasting 24 hours or more and not attributable to a nonischemic cause. Definition of hemorrhagic stroke: Rapidly developing clinical signs of neurological dysfunction attributable to a focal collection of blood within the brain parenchyma, ventricular system or subarachnoid space that is not caused by trauma.
2 secondary outcomes
Percentage of patients with the 90-day new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
Time frame: 90 days
Percentage of patients with the 90-day Modified Rankin Scale (mRS) ≤ 2
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Derived from this study: PubMed 42145088Lu L, Yang B, Wang Y, Zhu C, Liu Z, Li F, Yang S, Liu Y, Yang Y, Liu X, Huang L, Xu A, Zhu H. Liraglutide and Recurrent Stroke by Baseline Insulin Resistance: A Post Hoc Analysis of the LAMP Trial. Stroke. 2026 Jul;57(7):1960-1970. doi: 10.1161/STROKEAHA.125.056010. Epub 2026 May 18.
- Derived from this study: PubMed 41182740Zhu H, Yang B, Lu L, Li Y, Sui R, Liu K, Tan S, Wang L, Qiu J, Zhong J, Wei T, Bei Y, Huang J, Zhang S, Ji Y, Wu W, Li Y, Huang Y, Chen Y, Huang X, Zeng G, Zhang Y, Huang L, Li H, Wang X, Wang Y, Xu A; LAMP Investigators. Liraglutide in Acute Minor Ischemic Stroke or High-Risk Transient Ischemic Attack With Type 2 Diabetes: The LAMP Randomized Clinical Trial. JAMA Intern Med. 2026 Jan 1;186(1):46-54. doi: 10.1001/jamainternmed.2025.5684.
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liraglutide in people with Ischemic Stroke and Transient Ischemic Attack, run by First Affiliated Hospital of Jinan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anding Xu, M.D, Ph.D (+86 013392692160, tlil@jnu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with the 90-day new stroke events (ischemic or hemorrhagic) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03948347, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.