Semaglutide and Vascular Regeneration

What Was Tested

This registered phase 4 trial tested Semaglutide for atherosclerosis, cardiovascular disease & high blood pressure.

SEMA-VR is a prospective, randomized, 6-month long, open-label study of semaglutide.

The goal of this trial is to understand how semaglutide exerts cardio-protective effects in people with type 2 diabetes and/or obesity.

It had two arms (groups): Semaglutide (experimental) and Usual care (no intervention).

The registry classes the interventions as drug.

More on the Plan

Key cellular modulators of these processes include hematopoietic stem/progenitor cells (HPC) and their myeloid progenies, together referred to as vascular regenerative cells.

An established and innovative multi-parametric flow cytometry assay that utilizes lineage-specific cell surface marker expression and aldehyde dehydrogenase (ALDH) activity will be used to characterize and quantify vascular regenerative cells from peripheral blood samples.

Using this multi-parametric flow cytometry assay, it has been previously reported that people with T2D presented lower frequencies of vascular regenerative cells in their peripheral blood compared to people without T2D.

These studies established circulating vascular regenerative cells as key mechanistic constituents of vessel homeostasis that can be quantified from readily available blood samples, and highlighted the utility of the multi-parametric flow cytometry assay in providing high-throughput, real-time biological readouts of vascular repair potential or deficiency.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. AND meet one of the following ASCVD criteria:. History of ASCVD:.

The full record lists 20 inclusion and 13 exclusion criteria; among the exclusions: female subjects who are pregnant, planning pregnancy, or breastfeeding; currently on a glp-1ra or previously taken a glp-1ra; personal or family history of medullary thyroid carcinoma.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Semaglutide study: the atherosclerosis, cardiovascular disease & high blood pressure participants and staff both knew the treatment.

It started in 2023-04-29 with completion listed for 2024-12.

It ran at 2 sites in Canada (2).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: 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).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 100 people with atherosclerosis, cardiovascular disease & high blood pressure.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Atherosclerosis, cardiovascular disease & high blood pressure research.