GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide.

Glucagon-like-peptide-1 receptor agonists (GLP1-RAs) are recommended in subjects suffering from T2DM with a history or at risk for CV disease; however there is a lack of evidence on local actions of GLP1-RAs on inflammation and endothelial function.

It had two arms (groups): Semaglutide in addition to standard therapy (experimental) and Standard therapy alone (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 80 planned participants were the target.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Age ≥ 18 years. Stable clinical conditions, with controlled blood pressure, lipid profile, and glycemic values, based on assessments performed within 4 weeks prior to inclusion. Stable antidiabetic treatment for at least 6 weeks. For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at enrollment by one of the following:. Ability to understand study procedures and sign informed consent.

The full record lists 8 inclusion and 19 exclusion criteria; among the exclusions: age \> 85 years; previous treatment with semaglutide or glp1-ras; any history of ascvd.

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 participants and staff both knew the treatment.

It started in 2025-09-08 with completion listed for 2027-03-08.

It ran at 2 sites in Italy (2).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 80 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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