Recruiting

Semaglutide & Vascular Regeneration

Sponsor:

Canadian Medical and Surgical Knowledge Translation Research Group

Code:

NCT05870462

Conditions

Atherosclerosis

Cardiovascular Diseases

Diabetes Mellitus, Type 2

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Semaglutide Pen Injector

Study Details

Brief 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.

Conditions

Atherosclerosis

Cardiovascular Diseases

Diabetes Mellitus, Type 2

Obesity

Study ID

NCT05870462

Start date

Apr 29, 2023

Status verified date

Jul, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Semaglutide

Participants will receive once-weekly semaglutide subcutaneous injection \[Ozempic\] at escalating doses from 0.25 mg/week, 0.5 mg/week, to 1.0 mg/week.

no intervention: Usual care

Participants will continue to receive other usual medications, rehabilitation, procedures, and interventions as recommended by their healthcare providers.

Interventions

Semaglutide Pen Injector

  • 0.25 mg/week (non-therapeutic dose) during Weeks 1-4
  • 0.50 mg/week during Weeks 5-8
  • 1.0 mg/week during Weeks 9-24

Participants experiencing side effects (e.g. nausea, stomach pain, constipation, diarrhea, vomiting) at the maximum dose (1.0 mg/week) may be down-titrated to 0.50 mg/week.

Participants who had been receiving a dipeptidyl peptidase 4 (DPP-4) inhibitor (sitagliptin, saxagliptin, linagliptin, alogliptin) will stop taking their DPP-4 inhibitor upon randomization to this arm.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Brady Park, BMSc

2262359725brady.park@mail.utoronto.ca

Locations

North York Diagnostic and Cardiac Centre

Recruiting

North York, Ontario, Canada, M6B 1N6

Diagnostic Assessment Centre

Recruiting

Scarborough, Ontario, Canada, M1S4N6

More Information

Sponsor

Canadian Medical and Surgical Knowledge Translation Research Group

Last update posted

Jul 25, 2023

Last verified

Jul, 2023

Keywords

  • GLP-1 receptor agonists
  • GLP-1
  • Semaglutide
  • Vascular regeneration
  • Inflammation
  • Monocytes
  • Granulocytes
  • Hematopoietic progenitor cells
  • Cardiovascular risk
  • Type 2 diabetes
  • Obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Medical and Surgical Knowledge Translation Research Group on 2023-07-25.