NCT05630586

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for phase_2

Timeline
19mo left

Started Apr 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Apr 2023Dec 2027

First Submitted

Initial submission to the registry

November 1, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

April 12, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

April 25, 2023

Status Verified

November 1, 2022

Enrollment Period

2.4 years

First QC Date

November 1, 2022

Last Update Submit

April 24, 2023

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Modified Ranking Scale

    A shift towards better functional outcomes in the distribution of the modified Ranking Scale (mRS)

    90 (+/- 14) days

Secondary Outcomes (16)

  • Serious Adverse Events and/or Serious Unexpected Serious Adverse Events

    90 days

  • 90-day mortality

    90 days

  • One-year mortality

    1 year

  • Predefined SAEs

    1 year

  • Excellent functional outcome at 90 days

    90 (+/- 14) days

  • +11 more secondary outcomes

Other Outcomes (8)

  • Patient reported outcome: Quality of Life (QoL)

    90 (+/- 14) days

  • Patient reported outcome: Major Depression Inventory (MDI)

    90 (+/- 14) days

  • Patient reported outcome: SSQOL-DK

    90 (+/- 14) days

  • +5 more other outcomes

Study Arms (2)

Semaglutide 0.5 mg

ACTIVE COMPARATOR

Inj. Semaglutide 0.5 mg s.c., 0.5 mg per week for 4 weeks \+ standard care

Drug: SemaglutideOther: Standard care

Control

OTHER

Standard care

Other: Standard care

Interventions

SemaglutideDRUG

Subcutaneous Semaglutide, 0.5 mg weekly for 4 weeks. First dose given at inclusion.

Also known as: Ozempic
Semaglutide 0.5 mg
Standard careOTHER

Treatment according to Danish national clinical guidelines on stroke treatment, including reperfusion therapy if eligible.

ControlSemaglutide 0.5 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

RECRUITING

Related Links

MeSH Terms

Conditions

Ischemic Stroke

Interventions

semaglutideStandard of Care

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Claus Z Simonsen, Professor

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Mellemkjaer, MD

CONTACT

004551430175thomas.mellemkjaer@rm.dk

Claus Z Simonsen, Professor

CONTACT

004523669875clausimo@rm.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 29, 2022

Study Start

April 12, 2023

Primary Completion

September 1, 2025

Study Completion (Estimated)

December 1, 2027

Last Updated

April 25, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)