Semaglutide and Vascular Regeneration

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

SEMA-VR is a prospective, randomized, 6-month long, open-label study of semaglutide. Approximately 100 participants with type 2 diabetes and/or obesity will be randomized (1:1) to receive semaglutide at escalating doses (up to 1.0 mg/week) or usual care without semaglutide for 6 months.

The goal of this trial is to understand how semaglutide exerts cardio-protective effects in people with type 2 diabetes and/or obesity. The main question it aims to answer is:

• Does semaglutide treatment preserve or increase the number of vessel-repairing cells circulating in the blood?

Participants will:

• Be allocated to receive either semaglutide or usual care for 6 months

• Provide a blood sample at the baseline visit and another blood sample at the 6-month visit

Researchers will compare participants receiving semaglutide to those receiving usual care for any differences in the 6-month change in the number of vessel-repairing cells in the blood.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Canadian Medical and Surgical Knowledge Translation Research Group
• Collaborators: Unity Health Toronto; Western University, Canada

Criteria

Inclusion Criteria:

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

1. Documented T2D with inadequate glycemic control

2. BMI ≥ 30 kg/m^2 (obesity)

3. BMI ≥ 27 kg/m^2 (overweight) and at least one weight-related comorbidity, such as hypertension, dyslipidemia, or obstructive sleep apnea

AND meet ONE of the following ASCVD criteria:

1. History of ASCVD:

• Documented coronary artery disease

• Documented cerebrovascular or carotid disease

• Documented peripheral artery disease

2. 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

• 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:

1. Female subjects who are pregnant, planning pregnancy, or breastfeeding

2. HbA1c > 11.0 %

3. Currently on a GLP-1RA or previously taken a GLP-1RA

4. Personal or family history of medullary thyroid carcinoma

5. Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

6. New York Heart Association class IV symptoms of heart failure

7. Known history of severe liver disease (e.g. Child-Pugh Class B or C)

8. White blood cell count ≥ 15 x 10^9/L

9. Active infectious disease requiring antibiotic or anti-viral agents

10. Known acquired immunodeficiency syndrome such as HIV

11. On oral steroid therapy (e.g. prednisone or other corticosteroids) or other immunosuppressive agents (e.g. methotrexate)

12. 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

13. 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