Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes

What Was Tested

The trial (phase 4) is built around Semaglutide.

The diagnosis of coronary artery disease will be defined as the presence of coronary atherosclerosis confirmed by coronary artery computed tomography (coronary CT).

The study will evaluate the effect of treatment with flozin vs. semaglutide compared to treatment with metformin on the progression/regression of coronary atherosclerosis, change in plaque character, and control of cardiovascular risk factors.

It had three arms (groups): DAPAGLIFLOZIN (experimental), SEMAGLUTIDE (experimental) and METFORMIN (active comparator).

Dapagliflozin + OMT \& Lifestyle Intervention.

Semaglutide + OMT \& Lifestyle Intervention.

Metformin + OMT \& Lifestyle Intervention.

The registry classes the interventions as behavioral and drug.

Who Took Part

Enrollment: 300 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Age 18 - 80. Coronary CT scan performed \<3 months after inclusion in the study, at least of good quality. Stable treatment and control of cardiovascular risk factors, including dietary and lifestyle management for at least 4 weeks. Willing and able to give informed consent to participate in the study.

The full record lists 7 inclusion and 25 exclusion criteria; among the exclusions: severe valvular defect; clinical condition requiring surgical treatment of coronary artery disease; status after coronary artery bypass surgery.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-07-10 with completion listed for 2029-08-01.

It ran at 1 site in Poland.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Evaluation of the effect of GLP-1 analogue treatment on coronary artery disease progression AND Evaluation of the effect of flozin treatment on the progression of coronary artery disease (CO-PRIMARY ENDPOINTS) (time frame: 24 months).

It also tracked 30 secondary outcomes, for example Evaluation of the effect of each of the tested drugs vs. control group on progression of coronary artery disease, Comparison of the effect of semaglutide vs. flozin on coronary artery disease progression, Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - body weight, Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - total body fat, Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - body cell mass and Evaluation of change in inflammatory parameters in patients treated with semaglutide vs. patients treated with flozin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 300 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.