← Human Trials & Peer-Reviewed Studies
Semaglutide for Metabolic Intervention and Adipose Loss to Treat Atrial Fibrillation
Plain-language guide to NCT06499857: phase 3 randomized trial of Semaglutide, fat loss, obesity & body recomposition, 200 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06499857
- Phase
- phase 3
- Status
- recruiting participants
- Start
- 2025-04-14
- Completion (planned or actual)
- 2027-12
- Participants
- 200 (estimated)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Overweight or Obesity; Atrial Fibrillation
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Semaglutide for fat loss, obesity & body recomposition.
The goal of the study is to learn how a weight loss medication called semaglutide, which is used to treat obesity, in addition to standard AF treatment might affect AF, atrial fibrillation severity, and whether it changes the risk of atrial fibrillation recurring after standard AF treatments.
It had two arms (groups): Semaglutide (active comparator) and Placebo (placebo comparator).
Participants will have a 1 in 3 chance of receiving placebo.
The registry classes the interventions as drug.
More on the Plan
While many associations have been made, the underlying pathophysiological mechanisms linking obesity and AF are incompletely understood.
However, these studies have not systematically investigated the biological mechanisms underlying weight loss and AF.
Who Took Part
200 planned participants were the target.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age 18-75 years. BMI greater than or equal to 30 kg/m2. Ability to provide informed consent before any trial-related activities. Patients with type 2 diabetes mellitus (T2DM) will be included:. If the subject is taking basal insulin only or oral hypoglycemic agents or a combination of those.
The full record lists 12 inclusion and 22 exclusion criteria; among the exclusions: current use of glp-1 ra (glucagon-like peptide receptor agonists) or dpp4 (dipeptidyl peptidase-4)-inhibitors or use within the last 90 days prior to screening; current antiobesity medication use or use within the last 90 days prior to screening; A self-reported change in body weight of \> 5 kg (11 lb.) within 30 days before screening.
How the Study Was Run
The set-up was randomized, parallel-group and triple-blind.
Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.
Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.
As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2025-04-14 with completion listed for 2027-12.
It ran at 2 sites in United States (2).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Time to first AF event detected by routine outpatient monitoring (time frame: Baseline to Week 68). Change from baseline in AF burden detected by routine outpatient monitoring (time frame: Baseline to Week 68).
It also tracked 16 secondary outcomes, for example Weight loss, Change in waist circumference, Change in epicardial and/or pericardial adipose tissue volume, Change in left and right ventricular size (mass), Change in left and right ventricular size (volume) and Change in left and right ventricular function (ejection fraction).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Semaglutide in 200 people with fat loss, obesity & body recomposition.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Semaglutide compound page, Fat loss, obesity & body recomposition research.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.