Recruiting

Semaglutide

Sponsor:

University of Washington

Code:

NCT05780905

Conditions

Diabetes Mellitus, Type 2

Stroke (CVA) or Transient Ischemic Attack

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Not accepted

Interventions

Semaglutide Auto-Injector

Placebo

Study Details

Brief summary:

A human subjects research study, the primary purpose of which is to assess the EFFECTS OF SEMAGLUTIDE ON INTRACRANIAL BLOOD FLOW AND BLOOD-BRAIN BARRIER PERMEABILITY IN TYPE-2 DIABETES (T2D) through testing of the intervention on patients in a clinical setting. The study will randomize subjects with diabetes to either semaglutide or matching placebo. Magnetic resonance images will be primary endpoint measured at baseline and at one year to assess effect of this FDA approved medication.

Given the available evidence supporting the neuroprotective effect of this drug class and stroke reduction with semaglutide, and the investigators preliminary data showing that T2D had significantly reduced total number of distal arterial branches in the brain than non-T2D, the investigators expect treatment with semaglutide will be associated with improved intracranial blood flow condition.

Conditions

Diabetes Mellitus, Type 2

Stroke (CVA) or Transient Ischemic Attack

Study ID

NCT05780905

Start date

Jan 11, 2024

Status verified date

May, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Men and women 40-65 years of age
2. Subjects with type-2 diabetes >= 3 years and HbA1C 7%-10% with blood sugar control medications including insulin, metformin, sulfonylureas, or SGLT2 inhibitors
3. Medically stable
4. Has not received any investigational drug in the past 6 months
5. Willing to participate and sign informed consent.

Exclusion Criteria:

1. Contraindication to MRI or contrast agent
2. eGFR<45 mL/min/1.73m2 (eGFR is a measurement of kidney function)
3. Currently treated with glucagon-like peptide-1 receptor antagonist (same drug class as study intervention)
4. Unable to perform home-glucose monitoring
5. Currently need more than 100 units of insulin daily
6. Uncontrolled hypertension with systolic blood pressure (SBP)>180 mmHg or diastolic blood pressure (DBP)>100 mmHg
7. LDL-C>130 mg/dL or not on stable statin therapy in the past 6 months
8. Treatment with pioglitazone in the past 3 months
9. History of pancreatitis
10. History of myocardial infarction, stroke or transient ischemic attack
11. History or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
12. Hypersensitivity to semaglutide or any of the product components
13. Participating in other clinical trial
14. Women of child-bearing potential (ie, those who are not chemically or surgically sterilized or who are not post-menopausal) who have a positive pregnancy test at enrollment or who are breastfeeding or who plan to become pregnant in the next 15 months.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Subjects randomized to placebo for 1 year.

active comparator: Active

Subjects randomized to semaglutide for 1 year.

Interventions

Semaglutide Auto-Injector

Subjects have an equal chance of receiving semaglutide or placebo. Which treatment subjects receive is decided at random by a computer (purely by chance, like the tossing of a coin). Neither subjects, Study Site personnel nor image reviewers will know which treatment subjects are assigned to. The study drug must be taken weekly. The subject's other medications may be changed by the study's un-blinded Endocrinologist.

At baseline subject will receive and take home 0.25mg injector for use 3 more times. They will be given a 0.5mg injector and a 1mg injector for use beginning 5 and 9 weeks from baseline respectively.

The target dose for subjects is 1mg per week up to the 52 week treatment duration.

Placebo

Placebo

Primary outcome measure

  • Intracranial blood flow (IBF) [ Time Frame: Approximately 12 Months ]
  • bloodbrain barrier Ktrans [ Time Frame: Approximately 12 Months ]

Central Contacts and Locations

Central contacts

Francis Kim, MD

206-744-8305fkim@u.washington.edu

Locations

University of Washington - Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Francis Kim, MD

206-744-8305fkim@u.washington.edu

Principal Investigator:

Francis Kim, MD

More Information

Sponsor

University of Washington

Last update posted

Jun 5, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-12. This information was provided to ClinicalTrials.gov by University of Washington on 2024-06-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.