Semaglutide and Vascular Regeneration
- Status
- UnknownResults none
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 18 Years to no upper limit; BMI ≥30 required; conditions: Atherosclerosis; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Obesity
- Interventions
- Semaglutide Pen Injector
- Conditions
- Atherosclerosis; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Obesity
- Phase and size
- Phase 4 · 100 participants
- Dates
- Start 2023-04-29
Primary completion 2024-12 - Sponsor
- Canadian Medical and Surgical Knowledge Translation Research Group (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Changes in the mean frequency (%) of circulating ALDHhiSSClow primitive progenitor cells in individuals treated with semaglutide versus usual care for 6 monthsBaseline to 6 months post-randomization
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.