A Research Study of How Semaglutide Works in People With Disease Affecting the Heart and/or Blood Vessels and Type 2 Diabetes

What Was Tested

The trial (phase 1) is built around Semaglutide.

Participants will either get semaglutide or placebo ("dummy" medicine) - which treatment is decided by chance.

Semaglutide is a new medicine to treat type 2 diabetes and can be prescribed by doctors in some countries.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 101 actual participants took part.

It was open to people of any sex aged from 50 years with no upper age limit.

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

Examples of who could join: Male or female, age above or equal to 50 years at the time of signing informed consent. Body mass index equal to or less than 39.9 kg/m\^2. Diagnosed with type 2 diabetes 180 daysor more prior to the day of the first screening visit. Established cardiovascular disease.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: hospitalisation for unstable angina pectoris or transient ischaemic attack within 90 days prior to the day of the first screening visit; planned coronary, carotid or peripheral artery revascularisation; presently classified as being in new york heart association (nyha) equal to or above class iii.

How the Study Was Run

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

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 2019-08-12 with completion listed for 2022-12-16.

It ran at 4 sites in Sweden (2), Austria (1) and Denmark (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in maximum target-to-background ratio (TBR) for 18F-fluorodeoxyglucose (FDG) in the carotid arteries (time frame: From baseline (from 41 days before randomisation) to week 26).

It also tracked 4 secondary outcomes, for example Change in maximum target-to-background ratio (TBR) for 68Ga-DOTATATE in the carotid arteries, Change in total wall volume of the most diseased carotid artery, Change in lipid rich necrotic core (LRNC) volume of the atherosclerotic plaque in the most diseased carotid artery and Change in average fibrous cap thickness (FCT) of the atherosclerotic plaque in the most diseased carotid artery.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 101 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.