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Delfa

← All trials/NCT05870462

SEMA-VR

UnknownPhase 4

Semaglutide and Vascular Regeneration

Semaglutide and Vascular Regeneration in People With Diabetes and/or Obesity

Asset

Semaglutide

GLP-1 agonist

Listed sites

2

Recruiting sites

2

Estimated enrollment

100

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI ≥30•eGFR ≤60

Primary endpoint

•Changes in the mean frequency (%) of circulating ALDHhiSSClow primitive

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05870462
Org study IDPro00068765

Timeline

Milestones

Study start2023-04-29actual
Study first posted2023-05-23actual
Last update posted2023-07-25actual
Primary completion2024-12estimated (month precision)
Study completion2024-12estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Adults ≥ 18 years of age who meet one of the following Health Canada indications to receive subcutaneous semaglutide injections:

-Documented T2D with inadequate glycemic control
-Body mass index (BMI) ≥ 30 kg/m^2 (obesity)
-BMI ≥ 27 kg/m^2 (overweight) and at least one weight-related comorbidity, such as hypertension, dyslipidemia, or obstructive sleep apnea

2. AND meet one of the following ASCVD criteria:

-History of ASCVD:
-Documented coronary artery disease
-Documented cerebrovascular or carotid disease
-Documented peripheral artery disease
-No ASCVD but has 2 or more of the following risk factors:
-Cigarette smoker or stopped smoking within 3 months of screening
-Persistent hypertension (defined as office blood pressure ≥ 140/90 mmHg) or currently on antihypertensive medications
-BMI ≥ 27 kg/m^2
-estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73m^2
-Treated or untreated dyslipidemia
-Triglyceride ≥ 2.0 mmol/L
-HDL-C ≤ 1.0 mmol/L for men or ≤ 1.3 mmol/L for women
-High sensitivity C-reactive protein (hsCRP) ≥ 2.0 mg/L
-Documented micro- or macro-albuminuria
-Self-identified South Asian ethnicity

Exclusion criteria

•Female subjects who are pregnant, planning pregnancy, or breastfeeding
•HbA1c > 11.0 %
•Currently on a GLP-1RA or previously taken a GLP-1RA
•Personal or family history of medullary thyroid carcinoma
•Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
•New York Heart Association class IV symptoms of heart failure
•Known history of severe liver disease (e.g. Child-Pugh Class B or C)
•White blood cell count ≥ 15 x 10^9/L
•Active infectious disease requiring antibiotic or anti-viral agents
•Known acquired immunodeficiency syndrome such as HIV
•On oral steroid therapy (e.g. prednisone or other corticosteroids) or other immunosuppressive agents (e.g. methotrexate)
•Any malignancy not considered cured (except basal cell carcinoma of the skin). A subject is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening
•Any clinically significant or unstable medical condition that might limit one's ability to complete the study or comply with the requirements of the protocol, including: dermatologic disease, hematological disease, pulmonary disease, hepatic disease, gastrointestinal disease, genitourinary disease, endocrine disease, neurological disease, and psychiatric disease

Endpoints (4)

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)
3
Cardiometabolic biomarkers
1

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint/low confidence

Changes in the mean frequency (%) of circulating ALDHhiSSCmid pro-vascular monocytes in individuals treated with semaglutide versus usual care for 6 months

Time frame:Baseline to 6 months post-randomization

change from baseline, improvement

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Changes in the mean frequency (%) of circulating ALDHhiSSClow primitive progenitor cells in individuals treated with semaglutide versus usual care for 6 months

Time frame:Baseline to 6 months post-randomization

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Changes in the frequency (%) of circulating ALDHhiSSCmid pro-inflammatory monocytes in individuals treated with semaglutide versus usual care for 6 months

Time frame:Baseline to 6 months post-randomization

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Changes in the frequency (%) of circulating ALDHhiSSChi pro-inflammatory granulocyte precursors in individuals treated with semaglutide versus usual care for 6 months

Time frame:Baseline to 6 months post-randomization

change from baseline, improvement

Publications (11)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 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 6, 2026 snapshot.