Acute Ischemic StrokePhase 2ASSETNCT05630586
Acute Subcutaneous SemaglutidE in Acute Ischemic sTroke
A Phase 2 study testing Semaglutide in people with Acute Ischemic Stroke, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Can Semaglutide help reduce the damage caused by a stroke? ASSET trial is a national, multicenter, clinical trial, investigating the safety and efficacy of Semaglutide in non-diabetic patients with acute ischemic stroke. Stroke is a worldwide leading cause of long-term disability and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Apr 2023to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients (≥ 18 years) at the time of signed informed consent/proxy consent
- Acute ischemic stroke with disabling neurological deficits (defined as an impairment of one or more of the following: language, motor function, cognition, gaze, vision, neglect, or ataxia)
- Onset/last seen well to randomization < 4.5 hours
- None to moderate disability in daily living before symptom onset (pre-stroke modified Rankin Scale 0-3)
Who cannot join
- Diabetes (known) or plasma/point of care test-glucose >11.1 mmol/L at admission
- BMI< 22
- History of pancreatitis, medullary thyroid carcinoma
- Predisposition or known Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Short remaining life expectancy (< 12months) and/or severe neurodegenerative disease
- Pregnancy or planned pregnancy within 12 months or breastfeeding
- Renal impairment measured as estimated glomerular filtration rate (eGFR) value of <30 mL/min/1.73 m2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8000
Claus Z Simonsen, MD, 004523669875, clasim@rm.dk
About this study
Official title: The Safety and Efficacy of Acute Subcutaneous Administration of Semaglutide in Non-diabetic Patients With Acute Ischemic Stroke: A Multicentre, Phase 2, Prospective, Randomized, Open-label, Blinded Endpoint Trial
Can Semaglutide help reduce the damage caused by a stroke? ASSET trial is a national, multicenter, clinical trial, investigating the safety and efficacy of Semaglutide in non-diabetic patients with acute ischemic stroke.
Stroke is a worldwide leading cause of long-term disability and death. In the most common type of stroke (ischemic stroke), a blood clot obstructs an artery in the brain, and thereby prevents oxygenated blood from reaching an area of the brain. Brain cells are particularly vulnerable to the lack of oxygen. In the areas most severely affected by a stroke, brain cells die after 5 minutes. As more time pass, the affected area expands, and more brain cells perish. Today, efficient treatments aiming at reestablishing the flow of blood by either breaking down the blood clot (thrombolysis) or removing the clot (thrombektomi) are used. However, a significant amount of patients undergoing succesful treamtent, still suffer permanent disability following an ischemic stroke.
Read more
Semaglutide mimics a naturally occurring hormone (glucagon-like peptide-1) and is currently used to treat diabetes and obesity. However, semaglutide has also been shown to possess neuroprotective abilities in recent animal studies, where it reduced the damage caused by ischemic stroke in rats. This study sets out to investigate if it's possible to utilize Semaglutide, to increase the resilience of brain cells in patients with an acute ischemic stroke, with the aim of bettering their outcome.
The participants consist of non-diabetic patients with acute ischemic stroke, who will be randomized to:
- Treatment with subcutaneous Semaglutide, or
- No additional treatment (control group)
Both groups will be treated according to the standard national guidelies for acute ischemic stroke.
The two groups will then be compared to see, if patients in the group treated with Semaglutide are less impacted by their stroke.
Read the detailed description
For detailed project description, please refer to the full trial information at the Clinical Trials Information System (see 'More information' below for link).
- Conditions
- Acute Ischemic Stroke
- Being tested
- Semaglutide, Standard care
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Ozempic
Subcutaneous Semaglutide, 0.5 mg weekly for 4 weeks. First dose given at inclusion.
Standard careOther
Treatment according to Danish national clinical guidelines on stroke treatment, including reperfusion therapy if eligible.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide 0.5 mg | Active comparator | Inj. Semaglutide 0.5 mg s.c., 0.5 mg per week for 4 weeks
+ standard care Receives: Drug: Semaglutide; Other: Standard care |
| Control | Other | Standard care Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ranking Scale
A shift towards better functional outcomes in the distribution of the modified Ranking Scale (mRS)
Measured: 90 (+/- 14) days
Secondary outcomes (16)
Serious Adverse Events and/or Serious Unexpected Serious Adverse Events
Proportion of patients with Serious Adverse Events (SAE) and/or Serious Unexpected Serious Adverse Events (SUSAR) within 90 days of randomization
Measured: 90 days
90-day mortality
Measured: 90 days
One-year mortality
Measured: 1 year
Predefined SAEs
Frequency of predefined serious adverse events
Measured: 1 year
Excellent functional outcome at 90 days
mRS score of 0-1
Measured: 90 (+/- 14) days
MACCE and recurrent ischemic events, 90 days
Major Adverse Cardiac and Cerebral Events (MACCE) and recurrent ischemic events based on registry data at 3 months in AIS patients
Measured: 90 days
MACCE and recurrent ischemic events, 12 months
Major Adverse Cardiac and Cerebral Events (MACCE) and recurrent ischemic events based on registry data at 12 months in AIS patients
Measured: 12 months
Stroke recurrence at 12 months in patients with a stroke due to small vessel disease
Measured: 12 months
Early neurological improvement
NIHSS_24hour - NIHSS_baseline (NIHSS National Institutes of Health Stroke Scale)
Measured: 24 (+/- 8) hours
Change in body weight (kg)
90 days - baseline
Measured: 90 (+/- 14) days
Change in fasting plasma glucose
90 days - baseline
Measured: 90 (+/- 14) days
Change in body mass index (BMI)
90 days - baseline
Measured: 90 (+/- 14) days
Change in waist circumference
90 days - baseline
Measured: 90 (+/- 14) days
Difference in HbA1c
90 days - baseline
Measured: 90 (+/- 14) days
Diabetes diagnosis and/or antidiabetic medication
Diagnosed with and/or started antidiabetic medication within 1 year of enrollment
Measured: 12 months
Blood pressure, 90 days
Systolic and diastolic blood pressure (90 days BP - discharge BP)
Measured: 90 (+/- 14) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start12 Apr 2023
- Primary completionSep 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, Glostrup University Hospital, Copenhagen, Odense University Hospital, Herning Hospital, Aalborg University Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Claus Z Simonsen, Professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630586
- Sponsor's protocol ID
- ASSET
- Other IDs
- EUCT number: 2022-501072-25-02
- Acronym
- ASSET
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Acute Subcutaneous Administration of Semaglutide in Non-diabetic Patients With Acute Ischemic Stroke: A Multicentre, Phase 2, Prospective, Randomized, Open-label, Blinded Endpoint Trial
- ClinicalTrials.gov ID
- NCT05630586
- Acronym / sponsor ID
- ASSET / ASSET
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, Glostrup University Hospital, Copenhagen, Odense University Hospital, Herning Hospital, Aalborg University Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Nov 2022 (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.
Can Semaglutide help reduce the damage caused by a stroke? ASSET trial is a national, multicenter, clinical trial, investigating the safety and efficacy of Semaglutide in non-diabetic patients with acute ischemic stroke.
Stroke is a worldwide leading cause of long-term disability and death. In the most common type of stroke (ischemic stroke), a blood clot obstructs an artery in the brain, and thereby prevents oxygenated blood from reaching an area of the brain. Brain cells are particularly vulnerable to the lack of oxygen. In the areas most severely affected by a stroke, brain cells die after 5 minutes. As more time pass, the affected area expands, and more brain cells perish. Today, efficient treatments aiming at reestablishing the flow of blood by either breaking down the blood clot (thrombolysis) or removing the clot (thrombektomi) are used. However, a significant amount of patients undergoing succesful treamtent, still suffer permanent disability following an ischemic stroke.
Semaglutide mimics a naturally occurring hormone (glucagon-like peptide-1) and is currently used to treat diabetes and obesity. However, semaglutide has also been shown to possess neuroprotective abilities in recent animal studies, where it reduced the damage caused by ischemic stroke in rats. This study sets out to investigate if it's possible to utilize Semaglutide, to increase the resilience of brain cells in patients with an acute ischemic stroke, with the aim of bettering their outcome.
The participants consist of non-diabetic patients with acute ischemic stroke, who will be randomized to:
- Treatment with subcutaneous Semaglutide, or
- No additional treatment (control group)
Both groups will be treated according to the standard national guidelies for acute ischemic stroke.
The two groups will then be compared to see, if patients in the group treated with Semaglutide are less impacted by their stroke.
Detailed description
For detailed project description, please refer to the full trial information at the Clinical Trials Information System (see 'More information' below for link).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide 0.5 mg | Active comparator | Drug: Semaglutide, Other: Standard careInj. Semaglutide 0.5 mg s.c., 0.5 mg per week for 4 weeks + standard care |
| Control | Other | Other: Standard careStandard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients (≥ 18 years) at the time of signed informed consent/proxy consent
- Acute ischemic stroke with disabling neurological deficits (defined as an impairment of one or more of the following: language, motor function, cognition, gaze, vision, neglect, or ataxia)
- Onset/last seen well to randomization < 4.5 hours
- None to moderate disability in daily living before symptom onset (pre-stroke modified Rankin Scale 0-3)
Key exclusion criteria (7 listed)
- Diabetes (known) or plasma/point of care test-glucose >11.1 mmol/L at admission
- BMI< 22
- History of pancreatitis, medullary thyroid carcinoma
- Predisposition or known Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Short remaining life expectancy (< 12months) and/or severe neurodegenerative disease
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 |
|---|---|---|
| SemaglutideAlso: OzempicSubcutaneous Semaglutide, 0.5 mg weekly for 4 weeks. First dose given at inclusion. | Drug | Semaglutide 0.5 mg |
| Standard careTreatment according to Danish national clinical guidelines on stroke treatment, including reperfusion therapy if eligible. | Other | Control, Semaglutide 0.5 mg |
Primary outcome
Modified Ranking Scale
Time frame: 90 (+/- 14) days
A shift towards better functional outcomes in the distribution of the modified Ranking Scale (mRS)
16 secondary outcomes
Serious Adverse Events and/or Serious Unexpected Serious Adverse Events
Time frame: 90 days
90-day mortality
Time frame: 90 days
One-year mortality
Time frame: 1 year
Predefined SAEs
Time frame: 1 year
Excellent functional outcome at 90 days
Time frame: 90 (+/- 14) days
MACCE and recurrent ischemic events, 90 days
Time frame: 90 days
MACCE and recurrent ischemic events, 12 months
Time frame: 12 months
Stroke recurrence at 12 months in patients with a stroke due to small vessel disease
Time frame: 12 months
Early neurological improvement
Time frame: 24 (+/- 8) hours
Change in body weight (kg)
Time frame: 90 (+/- 14) days
Change in fasting plasma glucose
Time frame: 90 (+/- 14) days
Change in body mass index (BMI)
Time frame: 90 (+/- 14) days
Change in waist circumference
Time frame: 90 (+/- 14) days
Difference in HbA1c
Time frame: 90 (+/- 14) days
Diabetes diagnosis and/or antidiabetic medication
Time frame: 12 months
Blood pressure, 90 days
Time frame: 90 (+/- 14) days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Trial informaion on CTIS (Clinical Trials Information System), European Medicinal AgencyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Claus Z Simonsen, Professor principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide in people with Acute Ischemic Stroke, run by Aarhus University Hospital at 1 site in Denmark.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Apr 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 Denmark. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Mellemkjaer, MD (004551430175, thomas.mellemkjaer@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ranking Scale (time frame: 90 (+/- 14) days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2023.