GLP-1 Evidence

Not medical advice. A record of published research and our assessments of it. The limits

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.