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Semaglutide and Vascular Regeneration (SEMA-VR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05870462
Recruitment Status : Recruiting
First Posted : May 23, 2023
Last Update Posted : July 25, 2023
Sponsor:
Collaborators:
Unity Health Toronto
Western University, Canada
Information provided by (Responsible Party):
Canadian Medical and Surgical Knowledge Translation Research Group

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.


Condition or disease Intervention/treatment Phase
Atherosclerosis Cardiovascular Diseases Diabetes Mellitus, Type 2 Obesity Drug: Semaglutide Pen Injector Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Semaglutide and Vascular Regeneration in People With Diabetes and/or Obesity
Actual Study Start Date : April 29, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
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.
Drug: 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.

Other Names:
  • Ozempic
  • Wegovy

No Intervention: Usual care
Participants will continue to receive other usual medications, rehabilitation, procedures, and interventions as recommended by their healthcare providers.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Changes in the mean frequency (%) of circulating ALDHhiSSCmid pro-vascular monocytes in individuals treated with semaglutide versus usual care for 6 months [ Time Frame: Baseline to 6 months post-randomization ]
  2. Changes in the frequency (%) of circulating ALDHhiSSCmid pro-inflammatory monocytes in individuals treated with semaglutide versus usual care for 6 months [ Time Frame: Baseline to 6 months post-randomization ]
  3. Changes in the frequency (%) of circulating ALDHhiSSChi pro-inflammatory granulocyte precursors in individuals treated with semaglutide versus usual care for 6 months [ Time Frame: Baseline to 6 months post-randomization ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05870462


Contacts
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Contact: Brady Park, BMSc 2262359725 brady.park@mail.utoronto.ca

Locations
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Canada, Ontario
North York Diagnostic and Cardiac Centre Recruiting
North York, Ontario, Canada, M6B 1N6
Contact: Subodh Verma, MD, PhD         
Diagnostic Assessment Centre Recruiting
Scarborough, Ontario, Canada, M1S4N6
Contact: Subodh Verma, MD, PhD         
Sponsors and Collaborators
Canadian Medical and Surgical Knowledge Translation Research Group
Unity Health Toronto
Western University, Canada
Investigators
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Principal Investigator: Subodh Verma, MD, PhD Unity Health Toronto
Principal Investigator: David A Hess, PhD Robarts Research Institute, London, Ontario
Study Chair: David Mazer, MD Unity Health Toronto
Study Chair: Hwee Teoh, PhD Unity Health Toronto
Publications of Results:

Other Publications:
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Responsible Party: Canadian Medical and Surgical Knowledge Translation Research Group
ClinicalTrials.gov Identifier: NCT05870462    
Other Study ID Numbers: Pro00068765
First Posted: May 23, 2023    Key Record Dates
Last Update Posted: July 25, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Canadian Medical and Surgical Knowledge Translation Research Group:
GLP-1 receptor agonists
GLP-1
Semaglutide
Vascular regeneration
Inflammation
Monocytes
Granulocytes
Hematopoietic progenitor cells
Cardiovascular risk
Type 2 diabetes
Obesity
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Obesity
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Semaglutide
Glucagon-Like Peptide-1 Receptor Agonists
Hypoglycemic Agents
Physiological Effects of Drugs