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Trial · Interventional

Status unknownPhase 4Registry data

Semaglutide and Vascular Regeneration

Short name SEMA-VR

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
100 participants (estimated)
Sponsor
Canadian Medical and Surgical Knowledge Translation Research Group · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Canada

Start
29 Apr 2023
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
First posted
23 May 2023
Last update posted
25 Jul 2023
Conditions
Atherosclerosis · Cardiovascular Diseases · Diabetes Mellitus, Type 2 · Obesity

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph 4

    SEMA-VR

    NCT05870462

    29 Apr 2023 to est. Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Semaglutide Pen InjectorDrug

Arms2

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  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 outcomes(3)
  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2017

12 results

Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial.

Sorli et al. 2017The lancet. Diabetes & endocrinologycited by 600

PMID 28110911DOI 10.1016/s2213-8587(17)30013-xPUB-28110911

Rights unknown12 results

Indexing hint: Randomized controlled trial · 2016

8 results

Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.

Marso et al. 2016The New England journal of medicinecited by 5,002

PMID 27633186DOI 10.1056/nejmoa1607141PUB-27633186

Rights unknown8 results

More studies

1 study on this page

Indexing hint: Review · 2006

The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes.

Drucker et al. 2006Lancet (London, England)cited by 2,833

PMID 17098089DOI 10.1016/s0140-6736(06)69705-5PUB-17098089

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultCappellari R, D'Anna M, Menegazzo L, Bonora BM, Albiero M, Avogaro A, Fadini GP. Diabetes mellitus impairs circulating proangiogenic granulocytes. Diabetologia. 2020 Sep;63(9):1872-1884. doi: 10.1007/s00125-020-05142-3. Epub 2020 Apr 18. PMID 32306097
  • ResultTerenzi DC, Al-Omran M, Quan A, Teoh H, Verma S, Hess DA. Circulating Pro-Vascular Progenitor Cell Depletion During Type 2 Diabetes: Translational Insights Into the Prevention of Ischemic Complications in Diabetes. JACC Basic Transl Sci. 2018 Nov 5;4(1):98-112. doi: 10.1016/j.jacbts.2018.10.005. eCollection 2019 Feb. PMID 30847424
  • ResultHess DA, Terenzi DC, Trac JZ, Quan A, Mason T, Al-Omran M, Bhatt DL, Dhingra N, Rotstein OD, Leiter LA, Zinman B, Sabongui S, Yan AT, Teoh H, Mazer CD, Connelly KA, Verma S. SGLT2 Inhibition with Empagliflozin Increases Circulating Provascular Progenitor Cells in People with Type 2 Diabetes Mellitus. Cell Metab. 2019 Oct 1;30(4):609-613. doi: 10.1016/j.cmet.2019.08.015. Epub 2019 Aug 30. PMID 31477497
  • ResultHess DA, Trac JZ, Glazer SA, Terenzi DC, Quan A, Teoh H, Al-Omran M, Bhatt DL, Mazer CD, Rotstein OD, Verma S. Vascular Risk Reduction in Obesity through Reduced Granulocyte Burden and Improved Angiogenic Monocyte Content following Bariatric Surgery. Cell Rep Med. 2020 May 19;1(2):100018. doi: 10.1016/j.xcrm.2020.100018. eCollection 2020 May 19. PMID 33205058
  • ResultSattar N, Lee MMY, Kristensen SL, Branch KRH, Del Prato S, Khurmi NS, Lam CSP, Lopes RD, McMurray JJV, Pratley RE, Rosenstock J, Gerstein HC. Cardiovascular, mortality, and kidney outcomes with GLP-1 receptor agonists in patients with type 2 diabetes: a systematic review and meta-analysis of randomised trials. Lancet Diabetes Endocrinol. 2021 Oct;9(10):653-662. doi: 10.1016/S2213-8587(21)00203-5. Epub 2021 Aug 20. PMID 34425083

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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