Effect Of Semaglutide In Coronary Atheroma Plaque

What Was Tested

In this phase 3 trial, researchers set out to test Semaglutide.

The main objective of this trial is to evaluate the effect of Semaglutide on the burden of coronary atherosclerosis, based on the change in Percent Atheroma Volume (PAV) by quantifying atheroma plaque throughout the coronary tree based on the analysis of CCTA in asymptomatic subjects with T2D in optimized and stable treatment with Semaglutide.

It had 1 arm (groups): Semaglutide (experimental).

Patients on semaglutide.

The registry classes the interventions as drug.

More on the Plan

Patients with type 2 diabetes mellitus (DM2) are considered to be at high vascular risk (VR).

However, the VR risk may vary, depending on the presence of other cardiovascular risk factors (CVRFs), particularly dyslipidemia, smoking habit, hypertension, and obesity.

Atherosclerosis is considered a chronic immunoinflammatory process with a polygenic and multifactorial origin that begins early due to vascular endothelial dysfunction.

Atherosclerosis is a dynamic process that develops intermittently over time; periods of inactivity and rapid evolution are interspersed and modulated by environmental and genetic factors.

Who Took Part

The registry lists 120 planned participants were the target.

It was open to people of any sex aged from 35 years up to 65 years.

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

Examples of who could join: Men and women ≥35 and ≤ 65 years. Absence of previous history of clinical cardiovascular events. Coronary CT performed less than 3 months before starting study medication.

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: new york heart association (nyha) class \>ii; known stroke or transient ischemic accident; uncontrolled hypertension at randomization, defined as a resting systolic blood pressure of 180 mm hg at rest.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Semaglutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-11 with completion listed for 2024-12.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Plaque burden modification assessed by coronary CT and plaque quantification (time frame: 18 months).

It also tracked 5 secondary outcomes, for example Atheroma volume modification assessed by coronary CT and plaque quantification, Changes in composition of artery wall assessed by coronary CT and plaque quantification, Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) and Incidence of cardiovascular events.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Semaglutide in 120 people.

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

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