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Semaglutide and Vascular Regeneration

NCT05870462 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-07-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Unity Health Toronto

    collaborator OTHER

  • Western University, Canada

    collaborator OTHER

  • Canadian Medical and Surgical Knowledge Translation Research Group

    lead OTHER

Principal Investigators

  • Subodh Verma, MD, PhD · Unity Health Toronto

  • David A Hess, PhD · Robarts Research Institute, London, Ontario

  • David Mazer, MD · Unity Health Toronto

  • Hwee Teoh, PhD · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-29
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05870462 on ClinicalTrials.gov