Impact of Semaglutide on CD34+ EPC and Fat Derived MSC

What Was Tested

This registered phase 4 trial tested Semaglutide.

It had two arms (groups): Group A Placebo (placebo comparator) and Group B Active (active comparator).

Placebo.

Semaglutide.

The registry classes the interventions as drug.

More on the Plan

Endothelium and its progenitors, meaning endothelial progenitor cells (EPCs), are an established surrogate of cardiovascular risk outcome measures.

EPCs have been defined as CD34+ cells thereby identifying a defined homogenous population from a heterogeneous peripheral blood derived mononuclear cells.

On the other-hand serum biomarkers usually take much longer time to change secondary to an intervention.

Also the paracrine effect of damaged endothelium is secondary to gene expression changes that have been altered in the progenitor cells several months ahead of discernible changes in serum based biomarkers such as endothelium based inflammatory markers.

Who Took Part

10 actual participants took part.

It was open to people of any sex aged from 20 years up to 90 years.

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

Examples of who could join: Diagnosed with Type 2 diabetes mellitus. Body Mass Index (BMI) between 25.0-45.0 (both inclusive). Ability to provide informed consent (and document informed consent by signature) before any trial-related activities are conducted. Retinal examination within last 2 years of enrollment, showing no proliferative retinopathy.

The full record lists 9 inclusion and 26 exclusion criteria; among the exclusions: liver disease with alt, ast or alp ≥ x3 uln; known (recent) personal history of cerebral stroke or heart attack (myocardial infarction) within last 6 months; personal or family history of medullary thyroid cancer (mtc).

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-08-01 with completion listed for 2023-10-25.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: CD34+ Endothelial Progenitor Cell Number (EPC) Per Mononuclear Cells (MNC) Ratio (time frame: First Visit at Baseline and Last Visit at 24 weeks). CD34+ Endothelial Progenitor Cell Migration (EPC) Against Serum SDF1a Gradient (time frame: First Visit at Baseline and Last Visit at 24 weeks). Gene Expression of CD34+ Endothelial Progenitor Cell Number (time frame: First Visit at Baseline and Last Visit at 24 weeks).

It also tracked 9 secondary outcomes, for example Gene Expression of Subcutaneous Adipose Cell, Arterial Stiffness: Pulse Wave Analysis Augmentation Index, Arterial Stiffness: Pulse Wave Analysis Augmentation Pressure, Arterial Stiffness: Pulse Wave Analysis Augmentation Index 75, Body Composition: BMI and Body Composition: Body Fat Percent.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 10 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, all human trials.