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Semaglutide to Reduce Atrial Fibrillation Burden
Plain-language guide to NCT05209165: phase 4 randomized trial of Semaglutide, 132 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05209165
- Phase
- phase 4
- Status
- suspended
- Start
- 2023-05
- Completion (planned or actual)
- 2027-05
- Participants
- 132 (estimated)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Atrial Fibrillation; Obesity; Overweight
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Semaglutide.
Atrial fibrillation (AF) is the most common arrhythmia worldwide.
Semaglutide, a Glucagon-like peptide receptor 1 agonist (GLP-1 RA), is currently approved by the Food and Drug Administration for weight loss for individuals with and without diabetes.
It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 132 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.
The full record lists 1 inclusion and 12 exclusion criteria; among the exclusions: unable to consent; A personal or family history of medullary thyroid carcinoma; A personal or family history of multiple endocrine neoplasia syndrome type 2.
How the Study Was Run
It was run as a randomized, parallel-group and quadruple-blind study.
The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.
The Semaglutide group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2023-05 with completion listed for 2027-05.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Atrial fibrillation burden (time frame: 52 weeks).
It also tracked 13 secondary outcomes, for example Epicardial adipose tissue, Sleep apnea, Left atrial function, Weight change, Adherence and Adverse Events and Participation in VA MOVE.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Semaglutide in 132 people.
Its status is suspended; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Semaglutide compound page, all human trials.
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.