DelfaGLP-1 Atlas

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RecruitingPhase 4

Effects of Semaglutide on Intracranial Blood Flow and Brain-Barrier Permeability in Type-2 Diabetes

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

50

estimated

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

Primary endpoints

•Intracranial blood flow (IBF)•Bloodbrain barrier Ktrans

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05780905
Org study IDSTUDY00016594
Secondary IDU1111-1271-3352Novo Nordisk US

Timeline

Milestones

Study first posted2023-03-23actual
Study start2024-01-11actual
Last update posted2024-06-05actual
Primary completion2026-03-31estimated
Study completion2026-12-31estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age40 Years
Maximum age65 Years
SexAll
Healthy volunteersNot 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.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
2
Cardiometabolic biomarkers
1

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Inflammatory markers

Time frame:Approximately 12 Months

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Intracranial blood flow (IBF)

Time frame:Approximately 12 Months

descriptive

Primary/protocol endpoint/low confidence

bloodbrain barrier Ktrans

Time frame:Approximately 12 Months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.