Semaglutide Treatment On Coronary Progression

What Was Tested

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

The purpose of this research study is to see the effect of the diabetes medicine Semaglutide on a condition called atherosclerosis.

Atherosclerosis is a narrowing, blockage, or hardening of the arteries due to a build up of calcium.

This study will look specifically at the arteries involving the heart.

It had two arms (groups): Semaglutide (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

To determine the effects of semaglutide therapy on the morphology and composition of non-calcified coronary atherosclerotic plaque (NCP), including the progression of plaque volume.

Who Took Part

140 actual participants took part.

It was open to people of any sex aged from 40 years with no upper age limit.

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

Examples of who could join: Willingness to participate in the study and ability to sign informed consent.

The full record lists 4 inclusion and 25 exclusion criteria; among the exclusions: history of type 1 diabetes mellitus or a history of ketoacidosis; current use of glp-1-receptor agonists or use of a glp-1 receptor agonist within 3 mos. of screening; current use of sglt-2 inhibitors within 30 days of screening.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

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

It started in 2019-04-30 with completion listed for 2022-12-27.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Rate of change in non-calcified plaque volume (time frame: 12 months).

It also tracked 1 secondary outcome, for example Rate of change in total plaque volume.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 140 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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