Using semaglutide to improve blood vessel repair in patients with diabetes and obesity

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

This study is testing if the medication semaglutide can help people with diabetes and obesity improve their blood vessel repair over six months.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Canadian Medical and Surgical Knowledge Translation Research Group (Academic / other)
• Drugs / interventions: methotrexate, prednisone
• Locations: 2 sites (North York, Ontario and 1 other locations)
• Trial ID: NCT05870462 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of semaglutide, a GLP-1 receptor agonist, on vascular regeneration in individuals with type 2 diabetes and/or obesity. Approximately 100 participants will be randomly assigned to receive either semaglutide or usual care for six months. The study aims to determine whether semaglutide treatment can preserve or increase the number of vessel-repairing cells in the bloodstream. Blood samples will be collected at the beginning and end of the trial to assess changes in these regenerative cells using advanced flow cytometry techniques.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with type 2 diabetes, obesity, or related cardiovascular risk factors.

Not a fit: Patients without type 2 diabetes or obesity, or those who do not meet the cardiovascular risk criteria, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance cardiovascular health by improving the body's ability to repair blood vessels in patients with diabetes and obesity.

How similar studies have performed: Previous studies have shown promising results with GLP-1 receptor agonists in improving cardiovascular outcomes, suggesting potential success for this approach.

Eligibility criteria

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

Where this trial is running

North York, Ontario and 1 other locations

• North York Diagnostic and Cardiac Centre — North York, Ontario, Canada (Recruiting)
• Diagnostic Assessment Centre — Scarborough, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Subodh Verma, MD, PhD — Unity Health Toronto
• Study coordinator: Brady Park, BMSc

Conditions Atherosclerosis; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Obesity; GLP-1 receptor agonists; GLP-1; Semaglutide; Vascular regeneration