NCT04885634

Semaglutide for the Reduction of Arrhythmia Burden in Overweight AF Patients

Semaglutide for the Reduction of Arrhythmia Burden in Overweight and Obese Patients With Atrial Fibrillation (Pilot Study)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Axel Brandes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot study is to assess the feasibility of a double-blind, randomized placebo-controlled trial of semaglutide 2.4 mg subcutaneously once weekly on top of standard care compared to standard care alone.

Detailed description

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. The primary objective is to assess the feasibility of a double-blind, randomized placebo-controlled trial of semaglutide 2.4 mg subcutaneously (s.c.) once weekly on top of current standard care (lifestyle and risk factor management, oral anticoagulant and rate control therapy) versus current standard care alone in overweight or obese patients with symptomatic paroxysmal or early persistent AF. To assess recurrences of atrial fibrillation all participants will receive an implantable cardiac monitor.

Conditions

• Atrial Fibrillation
• Overweight and Obesity

Interventions

Type	Name	Description
DRUG	Semaglutide Injectable Product	Subcutaneous injection of Semaglutide 2.4 mg once weekly
DRUG	Placebo	Subcutaneous injection of volume-matched placebo once weekly

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-01-01
• Completion: 2024-11-01
• First posted: 2021-05-13
• Last updated: 2023-11-03