Semaglutide for the Reduction of Arrhythmia Burden in Overweight AF Patients

What Was Tested

The trial (phase 3) is built around Semaglutide.

It had two arms (groups): Intervention group (active comparator) and Control group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The SOCRATES-AF pilot study is a prospective, parallel-group, double-blind, randomized controlled trial in patients with paroxysmal or early persistent atrial fibrillation and overweight and obesity.

To assess recurrences of atrial fibrillation all participants will receive an implantable cardiac monitor.

Who Took Part

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: Signed informed consent before any study-related activity. ≥ 18 years of age at the time of signing informed consent. Body mass index (BMI) ≥ 30 kg/m2. Body mass index (BMI) ≥ 27 kg/m2 and at least 1 concomitant cardiometabolic risk factor (hypertension, dyslipidemia, or obstructive sleep apnea).

The full record lists 5 inclusion and 51 exclusion criteria; among the exclusions: general exclusion criteria; age ≥75 years; history of type 1 or 2 diabetes (history of gestational diabetes is allowed).

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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 2022-10 with completion listed for 2024-01.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants to Complete Recruitment (time frame: Up to 68 weeks, until end of treatment). Number of Participants to Complete Follow-up (time frame: Up to 75 weeks, until final follow-up). Total Resource Requirement (time frame: Up to 75 weeks, until final follow-up).

It also tracked 2 secondary outcomes, for example Incidence of adverse effects of Semaglutide in overweight and obese AF patients.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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