Semaglutide in Patients Undergoing Transcatether Aortic Valve Replacement

What Was Tested

This registered phase 3 trial tested Semaglutide.

A total of 826 participants will be randomized 1:1 to receive semaglutide or placebo as an add-on to standard-of-care, starting 3 months before TAVR and continuing for 24 months post-procedure.

It had two arms (groups): Treatment Arm (active comparator) and Control Arm (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 826 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Adults (≥18 years) undergoing TAVR for severe AS, and. BMI ≥30 kg/m2, or. BMI 27-30 kg/m2, AND at least one of the following:. Obstructive sleep apnea.

The full record lists 11 inclusion and 15 exclusion criteria; among the exclusions: treatment with an glp-1 receptor agonist within the previous 90 days; myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within the previous 60 days; planned coronary, carotid or peripheral artery revascularization known on the day of screening.

How the Study Was Run

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

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.

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 2026-04-01 with completion listed for 2030-09-01.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 14 secondary outcomes, for example Incidence rate of each component of the primary outcome, Change in high sensitivity C-Reactive Protein (hsCRP) (mg/L), Change in Lipid Profile (mg/dL), Change in waist circumference, Change in HbA1c (%, mmol /mol) and Change in systolic blood pressure.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 826 people.

With 826 participants it is a large trial for this field.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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